Cogent Analytics Jobs in Usa

Are you an experienced Sr Research Associate with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Sr Research Associate to work in Novato, CA.

Position Summary: The selected candidate will work in the Separations and Biophysical Assays team within the Analytical Sciences group to assist in the advancement of clients' therapeutics for clinical evaluation and potential commercialisation. The candidate will be responsible for method development (separations), provide routine testing and characterization support to partner groups to help with early candidate selection, process development, and drug substance and drug product process characterization. The ideal candidate will have hands-on experience working with biologics including but not limited to proteins, peptides, protein-conjugates, enzymes, biologics with a focus on method development and in-depth characterization. The ideal candidate will be able to perform quality work under limited supervision, apply problem solving techniques to maintain accurate results, promote improvements, and assure a safe, stable, on-target operation within the laboratory. The selected candidate should possess excellent analytical, organizational and communication skills and be a self-starter willing to work efficiently and collaboratively in a dynamic environment. This role is primarily a laboratory position; contact with chemicals is part of the job. The role is fully onsite (5 days a week, 8-hour days) with occasional evening or weekend work required. The employee will be trained to use common lab equipment and minimize exposure to hazards. Desktop or laptop computer work is also a major component of the job. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, knee crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities in this job include close vision, depth perception and ability to adjust focus.

Primary Responsibilities/Accountabilities:

• Primary responsibility is to support the Separations and Biophysics group within Analytical Sciences
• Be a hands-on presence in the laboratory, supporting biophysical/ biochemical assay development and qualification using HPLC and CE (must have) for various modalities (preferably biologics). LC-MS (high-res) experience is also desirable.
• Provide routine analytical characterization & testing support to partner groups including Upstream and Downstream PD, Formulations, and Research & Early Development (RED).
• Document experimental results in the company electronic lab notebook (Benchling), author procedures, and contribute to technical documentation (test methods, development reports).
• Actively participate in the operational aspects of the laboratory by conducting safety inspections, lab organization, ordering supplies, and performing routine equipment maintenance.
• Present scientific literature and results from ongoing studies at group meetings and other discussion forums at the company.
• Other duties as assigned.

Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 6+ years of experience in a Biologics or Pharmaceutical environment.
• Master's degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 4+ years of experience in a Biologics or Pharmaceutical environment.
• Hands-on experience in the biotechnology industry or academic setting with a broad range of analytical techniques focused on analytical testing and characterization for proteins, peptides, and protein-conjugates is required.
• Experience with biochemical characterization methods is required:
• SEC, SCX, RP-HPLC experience is a must (Agilent/Waters/Thermo LC instruments)
• Capillary Electrophoresis (PA800 or BioPhase8800) based methods (SDS for size separation, glycan profiling)
• cIEF (Maurice) experience is highly desirable
• LC-MS (Orbitrap/QToF/QQQ) method development experience also desirable
• Technical understanding of all aspects of analytical testing, phase appropriate regulatory requirements, method qualifications, and method transfers.
• Ability to independently troubleshoot issues, ideate, and develop insights into technical challenges and propose solutions to solve them.
• Demonstrates attention-to-detail and "right-the-first time' approach
• Excellent written and oral communication skills, with the ability to communicate complex information. Be able to present data/ideas to functional and cross-functional teams.
• Ability to influence others effectively and develop collaborative relationships with partner teams.
• Familiar with use of statistical software, electronic document management, and laboratory information management.
• Ability to effectively analyze complex problems and present results effectively within and beyond the department
• Ability to flexibly adapt to changing business needs and meet timelines.
• Strong organizational skills with the ability to effectively multi-task and prioritize.

Preferred:

• Experience in method development, qualification, and transfer to/from other laboratories, such as development and quality control.
• Knowledge of biopharmaceutical process development is a plus.
• Experience with automation is a plus.
• Experience working in a cross-functional environment.
• Good understanding of root cause analysis methodology.

Digital Marketing Manager (Hybrid)

Chicago, IL (Hybrid)

The American Medical Association (AMA) is the nation's largest professional Association of physicians and a non-profit organization. We are a unifying voice and powerful ally for America's physicians, the patients they care for, and the promise of a healthier nation. To be part of the AMA is to be part of our Mission to promote the art and science of medicine and the betterment of public health.

At AMA, our mission to improve the health of the nation starts with our people. We foster an inclusive, people-first culture where every employee is empowered to perform at their best. Together, we advance meaningful change in health care and the communities we serve.

We encourage and support professional development for our employees, and we are dedicated to social responsibility. We invite you to learn more about us and we look forward to getting to know you.

We have an opportunity at our corporate offices in Chicago for a Digital Marketing Manager on our Education Center team. This is a hybrid position reporting into our Chicago, IL office, requiring 2 days a week in the office.

This position will develop, design, implement and optimize AMA Ed
Hub marketing plans and tactics to help achieve mission and business growth and
engagement objectives for AMA Ed Hub. Leverage analytics-driven insights to advance
plans in alignment with established business priorities and objectives. Increase
AMA Ed Hub personalization through segmentation, adherence to digital best
practices and utilization and optimization of email and platform automation. Collaborate
with cross-functional teams, including content, product, analytics and other
internal stakeholders, to develop personalized campaigns while enhancing campaign
performance, learners' engagement and audience growth.

RESPONSIBILITIES:

Manage and Implement Personalization Plans

• Develop and execute acquisition and retention marketing plans for AMA Ed Hub users, leveraging personalization as a key driver of increase audience relevance, conversion and retention.
• Develop data-driven audience segments to deliver personalized messaging across channels while building and maintaining automated nurture and retention flows to drive audience engagement.
• Work closely with analysts, editors, web developers, and others to ensure the accurate branding, editorial accuracy and technical integrity of all content in marketing efforts.
• Plan and manage the execution of personalized user journeys across website and email marketing channels through our Customer Data Platform and Customer Communications Management platform to achieve retention and engagement goals.
• Work with email team to plan and execute segmented email campaigns, drip and triggered ones, email testing plan to optimize results.
• Drive satisfaction and loyalty programs that turn one-time users into long-term advocates.

Design and Implement Digital Marketing Campaigns

• Build audience segments for targeted, personalized email campaigns and automated customer journeys.
• Integrate personalization tools and APIs (e.g., CDPs, CRM systems, or marketing automation platforms to deliver real-time experiences.
• Work with platform team to create scalable solutions to support the automation of personalization of user journeys across marketing channels
• Design and implement visually appealing, responsive, and user-friendly website interfaces using HTML, CSS, and JavaScript frameworks.
• Act as marketing liaison with selected internal and external education providers to ensure promotion of educational content to appropriate channels.
• Work with collaborators, vendors and subject matter experts to create high quality and impactful marketing assets to deploy across channels, including but not limited to online banner ads, ad hoc email, newsletters etc.

Analysis and Optimization

• Monitor and analyze performance using tools such as Google Analytics (GA), Google DataStudio, Tableau, identifying trends and actionable insights to improve campaign effectiveness.
• Use behavioral data, preferences, and triggers to create and optimize tailored customer experiences.
• Pull and synthesize data from multiple sources (including marketing automation platforms) to create comprehensive campaign performance reports for several stakeholders.
• Develop data-driven recommendations to optimize marketing channels (email, site, etc.) based on KPIs such as user engagement, conversions, CTR, and ROI.
• Conduct A/B testing and multivariate testing to identify and implement the most effective campaign components (e.g., messaging, creative, calls-to-action), and document results to inform future strategies.

Staff Management

• Lead, mentor, and provide management oversight for staff.
• Responsible for setting objectives, evaluating employee performance, and fostering a collaborative team environment.
• Responsible for developing staff knowledge and skills to support career development.

May include other responsibilities as assigned

REQUIREMENTS:

1. Bachelor's Degree required; concentration in Marketing, Data Analysis, or other analytical related field preferred.
2. 5+ years of experience with marketing automation platforms such as Marketo, Salesforce Marketing Cloud as well as ESP platforms, CMS and CRM systems are required.
3. Demonstrated experience with HTML, CSS, and JavaScript required.
4. Experience in people management preferred.
5. Strong analytical skills and proficiency in analytics tools (e.g., Google Analytics, Adobe Analytics, Google Tag Manager, Tableau, Power BI).
6. Strong technical and creative skills, especially with written communication.
7. Exceptional attention to detail and possess the ability to manage multiple initiatives simultaneously to enable effective internal and external relationships.
8. Ability to develop specific goals and plans to prioritize, organize, and accomplish work.
9. Strong organizational and time management skills.
10. Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams.

The American Medical Association is located at 330 N. Wabash Avenue, Chicago, IL 60611 and is convenient to all public transportation in Chicago.

This role is an exempt position, and the salary range for this position is $85,680-$113,526. This is the lowest to highest salary we believe we would pay for this role at the time of this posting. An employee's pay within the salary range will be determined by a variety of factors including but not limited to business consideration and geographical location, as well as candidate qualifications, such as skills, education, and experience. Employees are also eligible to participate in an incentive plan. To learn more about the American Medical Association's benefits offerings, please click here.

We are an equal opportunity employer, committed to diversity in our workforce. All qualified applicants will receive consideration for employment. As an EOE/AA employer, the American Medical Association will not discriminate in its employment practices due to an applicant's race, color, religion, sex, age, national origin, sexual orientation, gender identity and veteran or disability status.

THE AMA IS COMMITTED TO IMPROVING THE HEALTH OF THE NATION

Title:Sr. Manager Data Governance

Location: Richardson, TX Hybrid

Duration: 6 months possibility of FTE conversion yes

JOB SUMMARY

This position incubates and establishes a leading-edge global Data Governance function to support business segments, corporate functions and the Digital & Technology stakeholders. The responsibility includes

• 
  
• Liaise directly with clients and account teams to provide strategic direction on implementation of data governance programs, best practices, adoption of standards, mast data management, and data quality improvement while leveraging leading-edge data governance tools and technology.
  
• Collaborate with and manage highly performing data governance and data management professionals that support occupier clients and account teams.
  
• Provide support on data strategy execution in the adoption of data products including enterprise data platform that provides game-changing analytics in the CRE industry.
  
• Serve as the data governance champion of strategic data products and supporting metadata and reference data.
  
• Implement and support data ownership and stewardship programs for stakeholders across the business to ensure that account teams adopt improved data governance and management practices.
  

ESSENTIAL DUTIES AND RESPONSIBILITIES

• 
  
• Participate in the strategy, planning, and execution for Enterprise Data Governance at, focusing on Building Operations & Experience (BOE) business segment. Ensure the company has urgency, sensitivity and thought leadership for competitive capabilities around data.
  
• Demonstrated leadership experience in a large, complex, global organization, including the ability to effectively work and communicate across organizational lines. Ensure business stakeholder understanding, alignment and commitment to the objectives of the data governance and management program(s). Be the champion and evangelist for data, the business value, and the potential innovations. Be the trusted advisor to senior leadership and peers.
  
• Demonstrated experience in building relationships and leading high-performing teams with top talents around the world. Build a high performance environment and execute a people strategy that attracts, retains, develops and motivates their team by fostering an inclusive work environment, communicating vision/ values/ business strategy and managing succession and development planning for the team.
  
• Collaborate with partners across business segments/ business lines, regions and accounts to develop consistent data governance capabilities at all levels, influencing decisions relating to policy, practices, supporting technology, and talent development.
  
• Establish leading data management practices and shared services relating to data quality, data provisioning, metadata, lineage, reference data, issue management and change management.
  
• Implement data governance as commodity services that could be leveraged by various clients in different industries. Understand clients' appetite and risk culture in day-to-day support activities and decision-making.
  
• Establish account team data governance programs. Define data domains and implement business oversight via essential data governance organizations and RACI (i.e. central data governance function, Data Ownership and Stewardship Program, etc.). Establish data standards, policies and controls. Design and implement the framework, including associated processes, necessary to sustain a data control environment. Monitoring compliance with data policies and standards
  
• Establish account team and cross-account data quality framework necessary to enable data quality reporting, issue identification, remediation and tracking, ultimately ensuring trust and confidence in data across domains.
  
• Guide the client accounts to adopt the strategic data products including existing account migrations and new account transitions. Manage data to support and its clients' business intelligence and scale appropriately with business growth.
  
• Experience in leading and driving leading-edge data innovation initiatives including big data, cloud computing, IoT, data virtualization and federation, etc., is a plus.
  
• Create and implement strategic approaches, plans, timelines, preparation of business cases to ensure expedited handling of client data protection, and other data compliance and security requirements.
  
• Develop and implement metrics needed to monitor/ report on data governance and data management progress
  
• Develop communication approaches and change management strategies; determines presentation focus and emphasis and prepares board-level presentations.
  
• Performs other duties as assigned.
  

SUPERVISORY RESPONSIBILITIES

Manages the planning, organization, and controls for a major functional area or department. Position will be responsible for managing direct reports across the Americas region and working with peers across all regions, requiring flexibility in schedule. May also be responsible for matrix reports. This position requires subordinates' recommendations for staff recruitment, selection, promotion, advancement, corrective action and termination. Effectively recommends same for direct reports to next level management for review and approval. Monitors appropriate staffing levels and reports on utilization and deployment of human resources. Leads and supports staff in areas of staffing, selection, training, development, coaching, mentoring, measuring, appraising, and rewarding performance and retention. Leads by example and models behaviors that are consistent with the company's values.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and EXPERIENCE

Bachelor's degree (BA/BS) from four-year college or university and a minimum of eight years of related experience and/or training, including five years of experience at the management level.

• 
  
• 5 or more years of progressively responsible management positions in complex organizations required. Demonstrated success with high visibility projects, leaders in technology use and development, change management, budget and business case development and staff development.
  
• 5 or more years of related experience in related industry; commercial real estate management preferred.
  
• 7 or more years of data management related experience such as data analysis, data governance, enterprise information management, data modeling, and data quality management. analytics experience desired, i.e., data visualization, data analytics, data mining, business intelligence, etc.
  
• Candidates must have experience working in large organizations with geographically dispersed teams and complex technical environments.
  
• Experience in dealing with internal and external customers, service providers and vendors. Must be able to manage competing priorities. Needs to be resilient; resolving conflicts quickly to achieve desired business results.
  
  

• 
  
• Bachelor's degree in business administration, Information Management, MIS, Business Intelligence and Data Science, Library Science, Computer Science or related fields; advanced degree preferred.
  

CERTIFICATES and/or LICENSES

None

COMMUNICATION SKILLS

• 
  
• Ability to comprehend, analyze, and interpret the most complex business documents. Ability to respond effectively to the most sensitive issues. Ability to write reports, manuals, speeches and articles using distinctive style. Ability to make effective and persuasive presentations on complex topics to employees, clients, top management and/or public groups. Ability to motivate and negotiate effectively with key employees, top management, and client groups to take desired action.
  
• Ability to establish and maintain a high level of customer trust and confidence in the overall information and analytics space
  
• Excellent oral, written, and presentation communication skills. Strong negotiation and group facilitation skills; ability to move a process forward, while meeting the needs of a variety of clients.
  
• Excellent collaboration, influence and leadership skills. Ability to work with various levels of peers including analysts, developers and executives regarding complex business and data related issues.
  
• Relationship management skills that include excellent listening and consultative capability, the ability to influence and negotiate with business and technology partners to drive change, and the ability to take a broad perspective and make key connections
  

FINANCIAL KNOWLEDGE

• 
  
• Requires basic knowledge of financial terms and principles.
  
• Participates in complex financial/business analysis and report reviews prepared peers or leaders.
  
• Manages to and oversees department budget.
  

REASONING ABILITY

• 
  
• Ability to solve advanced problems and deal with a variety of options in complex situations. Requires expert level analytical and quantitative skills with proven experience in developing strategic solutions for a growing matrix-based environment. Draws upon the analysis of others and makes recommendations that have a direct impact on the company.
  
  • 
    
  • Understanding of global organizational design and the ability to shape and drive large-scale, cross-functional programs around people, technology, processes, and tools.
    
  • Demonstrated ability to balance long-term strategy with quick wins.
    
  • Demonstrated ability for strategic influencing and education of cross-functional stakeholders about the strategic importance and value of data governance
    
  • Excellent managerial skills; collaborative, imaginative, resourceful, reliable, technically savvy.
    
  • Superior analytical and creative problem-solving skills. Demonstrated successes in data analysis, drawing conclusions and improvement. Apply listening and consultative skills to understand business needs; be able to interpret requirements, identify impacts and analyze problems to determine impacts to business processes across the organization.
    
  • Ability to work well under deadlines, ability to work in a multi-tasking production environment to make good judgments about competing priorities.
    
  • Ability to tell a story to explain or sell a concept.
    
  
  
  

OTHER SKILLS and/or ABILITIES

• 
  
• Utilizes an entrepreneurial approach and develops innovative solutions.
  
• Ability to write business cases, process maps, presentation materials and articles using distinctive style.
  
• Ability to make effective and persuasive presentations on complex topics across various levels of leadership
  
• Expert level analytical and quantitative skills with proven experience in developing strategic solutions for a growing matrix-based multi-industry sales environment.
  
• Ability to use strong conceptual and analytical skills to generate insights and recommendations.
  
• Demonstrated information management and quantitative skills, including working knowledge of IT infrastructure, various technologies/ platforms, and aligned vendor solutions with enterprise strategic priorities.
  
• Experience managing small to mid-size teams and delivering results.
  
• Thorough knowledge of cutting-edge data management tools, industry advances, etc.
  
• Superior project management/ consulting and leadership skills. Demonstrated ability to facilitate complex, mission critical projects and to develop, participate in and guide multi-disciplinary work teams. Manage task timelines and deliverable schedules and share concerns about deliverables, timelines, and issues with Data Governance services or deliverables.
  
• Superior ability to manage, manipulate and analyze raw data, draw conclusions, and develop actionable recommendations using technology. Articulate the issues and resolutions via business-friendly communications. Serve as primary day-to-day contact for regional data management issues.
  
• Advanced understanding of data quality management. Knowledge of data governance and how it impacts business processes.
  
• Knowledge of master data management in a global environment, including data lifecycle and maintenance processes.
  
• Skills in MS Visio, Word and PowerPoint is a plus.
  
• Experience with reference data management tools at including Collibra, MS Excel, SQL query, etc., is a plus.
  
• Software development lifecycle knowledge, with background in agile philosophies and
  

Position Summary:

The Associate Director, Quality Control will be responsible for providing strategic, scientific, and operational leadership for the development, qualification, validation, and lifecycle management of analytical methods supporting Upstream Bio’s lead program verekitug. This role will manage and execute GMP quality control (QC) activities directly related to batch release for clinical trial material supply. The leader in this role must assure that quality controls for investigational new drugs (investigational medicinal products) meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations. The Associate Director will report to Senior Director of Analytical and serve as a key partner to Quality, CMC, Regulatory, and cross-functional teams. This individual will provide technical guidance and business acumen to ensure execution of analytical activities for late-stage programs through BLA/MAA submission, approval, and commercial launch.

Key Responsibilities:

• Author, review and approve analytical method procedures/SOPs
• Author, review and approve analytical method transfer/qualification/validation protocols and reports
• Manage external CDMOs and CROs to execute Development and GMP release and stability testing of Drug Substance and Drug Product in a compliant-manner
• Establish and manage reference standard and critical reagent programs
• Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review.
• Perform data verification and audits in order to ensure accuracy of data and analytical processes.
• Ensure compliance with company policies and SOPs as well as global health authority guidelines.
• Create, analyze, verify, and approve QC data such as method validation, release and stability, results, reports, and Certificates of Analysis (COAs).
• Generate, review, and revise specifications, SOPs, and other QC laboratory and testing documentation.
• Lead Out-of-Specification (OOS), Out-of-Trend (OOT), and Deviation investigations related to the QC laboratory and ensure effective corrective and preventive actions (CAPAs) are implemented.

Qualifications:

• Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful.
• Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
• Proficiency with Microsoft software (Word / EXCEL / PowerPoint), Stability software and statistical analysis/trending to support shelf life and labeling is expected.

Knowledge and skills (general and technical) preferred:

• Broad background, strong comprehension, and demonstrated skills in analytical methods development/validation/transfer/similar, reference standards characterization/structural elucidation, and unknown identification.

Education level and/or relevant experience required:

• Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of demonstrated success in leading cross-functional teams and managing projects along with 7+ years relevant analytical experience in a cGMP-compliant pharmaceutical laboratory environment. Any ASQ or other certifications is a plus.

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at .

Compensation

Target Salary Range: $176,400 - $215,600

*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

Title: QC Specialist II

Location: Portsmouth NH

Duration: 12 Months

100% On site

Position Overview

We are seeking a QC Specialist II to join the Quality Control team in Portsmouth, NH. This role supports production and laboratory operations through technical transfer activities, analytical testing, and quality system documentation within a GMP-regulated pharmaceutical environment.

The QC Specialist II will perform in-process, lot release, and stability testing, support method transfers and validations, and contribute to quality investigations and continuous improvement initiatives. The ideal candidate will have experience working with GMP quality systems, laboratory software, and analytical instrumentation while ensuring compliance with data integrity and regulatory requirements.

Key Responsibilities

Quality Control & Analytical Testing

• Perform analytical testing for in-process samples, lot release, and stability studies.
• Conduct testing to support investigations, method transfers, and validation activities.
• Review analytical assays and laboratory results to ensure accuracy and compliance.
• Support laboratory operations by troubleshooting testing issues and identifying deviations from standard procedures.

Technical Transfer & Laboratory Projects

• Support technical transfer activities within the Quality Control laboratory.
• Participate in method transfers, new instrument implementation, and method qualification projects.
• Assist with the validation and qualification of laboratory software and analytical systems.
• Serve as a Subject Matter Expert (SME) for at least one laboratory software system.

Quality Systems & Documentation

• Author and review GMP documentation, including:
• Deviations
• CAPA records
• Change controls
• Investigation reports
• Test methods and procedures
• Participate in root cause investigations and support corrective and preventive actions.
• Ensure compliance with data integrity (DI) policies, procedures, and regulatory requirements.
• Maintain accurate laboratory records in accordance with GMP and regulatory guidelines.

Collaboration & Communication

• Communicate with cross-functional teams to support project priorities and technical needs.
• Provide training and guidance to other team members when needed.
• Interpret analytical data and present findings to internal stakeholders.
• Participate in team meetings and contribute to continuous improvement initiatives.

Required Qualifications

• Associate's Degree in Microbiology, Biochemistry, or a related scientific field.
• Experience working in a GMP-regulated pharmaceutical or biotechnology environment.
• Experience with quality systems and documentation including deviations, CAPA, investigations, and change control.
• Strong understanding of data integrity principles and regulatory compliance.
• Ability to analyze data, troubleshoot issues, and support root-cause investigations.
• Strong written and verbal communication skills

Technical Skills

Experience with the following systems and software is preferred:

• SoftMax Pro
• Empower
• SoloVPE
• LIMS
• TrackWise
• Microsoft Office Suite (Word, Excel, PowerPoint)

Additional experience with software validation activities, including writing GMP procedures, validation documents, and executing test scripts, is highly desirable.

Core Competencies

• Strong analytical and problem-solving skills
• Ability to manage multiple priorities and projects
• Excellent communication and teamwork skills
• High attention to detail and commitment to quality and compliance
• Self-motivated with the ability to work independently and within a team environment

#TB_PH

#ZRPH

QC Supervisor

Kelly® Science & Clinical is seeking a QC Supervisor for a direct-hire position at a cutting-edge client in Fort Collins, CO. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Location:Ft. Collins, CO (onsite)

Shift: 1st or 2nd

Salary: $100-105,000 + Benefits

Essential Duties & Responsibilities

• Prioritize workload to meet timelines while ensuring on-time delivery of all projects, testing and action items.
• Take ownership of tasks and results from initiation to completion to meet commitments and proactively address outcomes.
• Escalate and communicate items which arise per the timelines specified in the department escalation strategy.
• Execute all business and department goals and initiatives on time.
• Ensure adherence for compliance with all processes and procedures including training completions, QE and CAPA due dates, notebook and logbook audits, archiving, schedules, internal assessments.
• Issue all Certificates of Analysis within 2 business days of last test completion.
• Generate, monitor and report weekly team and analyst KPIs.
• Supervise the testing and release of Tolmar products, cleaning samples, EM, Bioburden, Endotoxin, raw materials, and stability samples.
• Strive to balance workload across all sites and teams to ensure adequate resource allocation.
• Partner with the scheduler to schedule all testing and reviews, review the weekly schedule and ensure company and department targets are met in the shortest possible cycle time.
• Provide assistance, training and leadership for direct reports through utilization of the OTD resources.
• Create, revise and monitor training progress utilizing training matrices for immediate functional areas, and collaborate with team on remediation of training gaps for site training matrix.
• Set and communicate clear expectations for analysts including providing regular feedback and coaching, monitoring progress and fostering employee development to align individual and team performance with organization goals.
• Create and revise developmental plans to help employees grow their skills and advance their careers.
• Monitor and discuss progress of employee’s performance, growth and development in one on ones utilizing the career ladder and KPIs.
• Establish sample priorities for QC scheduler, submit schedule tickets as needed and ensure adherence to ship dates.
• Partner with the investigations team and the scheduler to ensure all actions for QEs are completed in 24 hours, second analyst testing is completed in less than 5 business days and QEs are closed on time (less than 45 business days).
• Support and execute all potential 3-day field alert investigations and actions expeditiously.
• Submit document change requests for all document updates and minimize document revisions for routine updates where possible.
• Ensure all samples logged into the LIMS system are submitted correctly.
• Identify, and complete cost savings initiatives and facilitate continuous improvement.
• Participate in leadership development activities and take an active role during department and company activities.
• Aid in setting procedure and ensure that all operations and functions (including the laboratory) are in full FDA, cGMP compliance and staff is properly trained.
• Utilize senior analysts to assist in training, document updates, laboratory investigations, projects, or advanced technical issues.
• Conduct and coordinate laboratory investigations, and all associated actions.
• Review and approve technical reports, test methods, specifications and procedural documents and ensure overall validity of the analytical results and review stability reports.
• Participate in project teams, company and department meetings, third party audits, and regulatory audits.
• Monitor departmental spending to stay within the established budget.
• Demonstrate leadership aptitude in technical functions and people management.
• Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
• Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers.
• Accountable for meeting departmental and compliance timelines.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to, container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Participate in the interview and selection process for candidates, as required.
• Perform other duties as required by business demands.

Knowledge, Skills & Abilities

• Possesses a strong sense of purpose and drive to meet deadlines without sacrificing quality.
• Balances the need for speed with a commitment to accuracy and quality, completing tasks thoughtfully and effectively
• Expert knowledge in analytical testing of drug substances and formulations for Chemistry or Microbiology.
• Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
• Proficient with computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Knowledge in analytical method validation and instrument qualification.
• Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work.
• Technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.
• Exceptional interpersonal and organizational skills that lead directly to the advancement of others and of the QC department.
• Ability to supervise a team of analytical professionals that is fully compliant with current Good Manufacturing Practices.
• Knowledge of analytical troubleshooting and product investigation.
• Effective oral and written communication.
• Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers, CCIT, Endotoxin, MODA,.
• Ability to prepare, review, conduct and assess analytical method validations, feasibility and suitable for use.
• Ability to coordinate activities to assure customers’ needs are met in terms of sample analysis cycle time.

Education & Experience

• Bachelor’s degree in science, preferably in Chemistry or Biochemistry, or Microbiology.
• 6+ years’ experience in an analytical laboratory environment with at least five years in a pharmaceutical GMP setting.
• Supervisory or team lead experience is preferred.

What Happens Next

Once you apply, you’ll move forward to next steps if your background aligns with the role. If not, no worries — you’ll remain in our network, giving our Science & Clinical recruiting team access to your profile, helping open the door to future opportunities.

Ray Therapeutics mission is to restore vision to people with retinal degenerations. RayTx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate RTx-015 in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications.

We are currently seeking an exceptional team member to join our team as a CMC Technical Development Specialist. This role will report to the Senior Director, CMC Analytics, and will have an active role supporting the general CMC department as well as our process, product management, and MSAT teams. The position requires hands on support for AAV analytical development, transfer, and qualification through validation support for our lead candidates from Pre-IND to BLA. The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and may require travel to our external vendors at in the United States. If the lab is where your curiosity comes alive and breakthroughs spark your excitement, this position may be right for you.

The job duties and responsibilities include but is not limited to the following:

• Collaborate with analytical development and process development teams to develop, qualify and/or validate AAV gene therapy assays.
• Develop analytical methods and support method optimization/characterization.
• Independently execute analytical assays including molecular biology assays, chemical/biochemical assays, and cell-based biological potency assays, for internal CMC commitments, process monitoring, release and stability.
• Develop protocols for analytical transfer, qualification and /or validation studies and execute associated wetlab work.
• Present aasay methodology and principles to external partners and support method transfers.
• Execute routine assays with high presicion and provide data summaries and reports in a timely manner.
• Document all raw data, method plans, and summarize conclusions.
• Author and review Test Methods, Reports, and Protocols.
• Work in the lab independently and in a collaborative environment with minimal guidance.
• Support CMC outside of analytical teams to move programs forward, e.g. shelf-life determination, upstream characterization etc.

Qualifications and Experience:

• BA/BS in Biochemistry, Biology, bioengineering or a related fields and at least 10 years of Biotech/pharmaceutical industry experienced required.
• Experienced in compendial methods, CE-SDS, gel electrophoresis, HPLC, DLS, ddPCR or qPCR, ELISA, and cell based potency assays.
• Hands on experience in AAV gene therapy analytical methods and testing required.
• Experience in precision pipetting and cell culture (handling, aseptic techniques, maintenance), plate-based imaging, ELISAs, luminescence and fluorescence detection techniques.
• Curiosity and good scientific knowledge and acumen.

Compensation Range and Benefits:

• For this role, the anticipated base salary range: $145,000 to $160,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
• Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.

At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

All employment is decided on the basis of qualifications, merit, and business need.

Search Firm Representatives Please Read Carefully

Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.

Lab Assistant – Dover, DE

Contract: 3 months, contract-to-hire

Pay Rate: $24–$26/hr. DOE

Must-Have Skills: LC-MS, GC-MS, and sample preparation

Job Description Summary

The Instrument Readiness Specialist provides operational and technical support for LC-MS, HPLC, and GC-MS laboratories at Customer facilities in Delaware. This role includes routine instrument operation, sample preparation support, preventive maintenance, performance monitoring, and compliant documentation following Customer SOPs, validated methods, and regulatory requirements.

The position requires strong attention to detail, the ability to work independently in a laboratory environment, and effective collaboration with Customer scientists and project stakeholders to ensure reliable analytical operations.

Job Responsibilities

• Provide hands-on operational support for LC-MS, HPLC, and GC-MS instrumentation at Customer facilities, including the DuPont Experimental Station (Wilmington, DE) and New Castle, DE, following SOPs, validated methods, and compliance requirements.
• Perform routine operation of analytical systems: instrument startup/shutdown, method loading, sequence/sample queue setup, data acquisition, and basic system checks.
• Support sample preparation activities: dilution, extraction, filtration, derivatization (as applicable), reagent preparation, consumable selection, and proper sample labeling per Customer-approved procedures.
• Monitor and assess instrument performance: chromatographic stability, pressure/flow profiles, vacuum system performance, detector response, ion source condition, mass accuracy, and column integrity; promptly communicate deviations or abnormal trends.
• Conduct routine preventive maintenance and system upkeep: solvent/mobile phase preparation, degassing, tubing/fitting inspection, leak checks, column flushing, injector/ion source cleaning, vacuum pump monitoring, tuning verification, and routine calibration per manufacturer and Customer requirements.
• Support day-to-day lab operations: equipment readiness, workflow coordination, and effective communication with project leads and local stakeholders.
• Comply with all site-specific safety, laboratory access, emergency response, and environmental health requirements; participate in required safety, EHS, and instrumentation training programs.
• Maintain accurate documentation of instrument usage, maintenance activities, experimental observations, deviations, and corrective actions per Customer practices and data integrity standards.
• Prepare analytical summaries, instrument performance logs, and status updates as requested.
• Ensure proper archiving of raw data, chromatographic results, mass spectral files, electronic logs, and supporting documentation within Customer systems.
• Document and escalate deviations, nonconformances, or unexpected findings promptly; support quality assurance, audit readiness, and inspection activities as requested.

Note: Management reserves the right to assign or reassign duties at any time.

Critical Skills

• Working knowledge of LC-MS, HPLC, and GC-MS instrumentation and laboratory workflows
• Ability to operate analytical instruments according to SOPs, validated methods, and compliance requirements
• Strong attention to detail and commitment to data integrity
• Ability to monitor instrument performance, identify deviations, and escalate issues
• Hands-on experience with routine instrument maintenance, troubleshooting, and preventive care
• Strong organizational and time-management skills in a fast-paced laboratory environment
• Ability to follow instructions and adhere to established procedures
• Effective communication and collaboration with scientists, vendors, and site stakeholders
• Ability to work independently while supporting team objectives

Basic Qualifications

One of the following education and experience combinations:

• Bachelor’s degree in chemistry, biology, biochemistry, or related discipline + 3+ years of relevant lab experience supporting analytical instrumentation
• Associate’s degree in a scientific/technical discipline + 5+ years of hands-on experience supporting LC-MS, HPLC, or GC-MS systems
• High School diploma or GED + 7+ years of directly related laboratory experience in an analytical environment

Additional Requirements:

• Basic proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint)

Preferred Qualifications

• 5+ years supporting LC-MS, HPLC, and/or GC-MS in industrial, academic, or regulated labs
• Master’s degree in chemistry, analytical science, or related discipline
• Experience in SOP-driven or regulated labs (GLP, GMP, or similar)
• Familiarity with analytical data systems, ELNs, and data archiving
• Demonstrated ability to support audits, inspections, or QA activities

Working Environment

• Work in laboratory and controlled environments requiring PPE (lab coat, safety glasses, etc.)
• Fast-paced environment with high job completion demands
• Stationary work >25% of the time; occasional movement between labs, corridors, adjoining rooms, and buildings
• Frequent bending, squatting, stretching, and reaching for instrument operation
• Occasionally lift/move up to 25 pounds (potential up to 50 pounds)
• Vision requirements: close-range observation, color vision, peripheral vision, depth perception, ability to adjust focus
• Occasional use of computers and office machinery
• May handle hazardous waste per regulations
• Exposure to lab hazards: extreme temperatures, biological materials, hazardous chemicals
• May require medical clearance, respiratory protection training, and respirator fit testing

Hybrid Onsite Schedule In office T, W, Th; Remote M, F

Job Description: Data Analyst – Global Patient Access Program (GPAP)

Location: North Chicago, IL, USA (Hybrid eligible), AP30

Overview: The Data Analyst for the Patient Assistance Program (PAP), supporting GPAP’s data transformation and governance, will be instrumental in building and maintaining the backbone of automated reporting and KPI dashboards. This role ensures a single source of truth for GPAP operations, drives analytics innovation, and supports the integration and consistency of data across the program. You’ll collaborate closely with workstream leaders, lead in bi-weekly scrum sessions, and deliver insight-rich, timely outputs for senior leadership.

Key Responsibilities:

• Develop, automate, and maintain standardized PAP reporting, KPI dashboards, and ad hoc analytics tools using Tableau, Excel, and Snowflake.

• Lead twice-weekly Scrum sessions with workstream team members, ensuring progression of data tasks, intake of new data requests, and alignment on analytics approaches in a Smart Sheet-driven, agile environment.

• Ensure data consistency, quality, and accuracy across all platforms, supporting GPAP governance and the creation/control of the 'source of truth.'

• Enable and facilitate self-service dashboards and reporting marts for internal and external stakeholders.

• Collaborate with cross-functional partners (BTS, ACA, GPAP, Steer Co) to support program data needs, forecasting, and reporting methodologies.

• Support quarterly and weekly reporting processes—including application, shipment, and claim-level analytics.

• Partners with data lead to document extraction methods, automate/accelerate reporting, and track program impacts, escalations, and business intelligence.

• Identify new opportunities for advanced analytics or insights to increase PAP operational efficiency and program sustainability.

Qualifications:

• Bachelors in a relevant field (Analytics, IT, Business, Data Science, or related)

• 3-5 years’ experience in data analytics, reporting, or business intelligence in healthcare, pharma, or related industry

• Advanced proficiency in Tableau and Excel; experience with Smart Sheet and Snowflake (SQL skills required)

• Demonstrated experience leading agile meetings (scrum/project management preferred)

• Strong attention to detail, data integrity, and quality control

• Experience in KPI development, dashboard design, and self-service reporting

• Effective communicator with ability to drive cross-team consensus and present findings to varied audiences

• Collaborative mindset, able to work in fast-paced, matrixed environments

• In office Tues, Wed, Thurs

Preferred:

• Experience in patient assistance programs or US healthcare market access

• Familiarity with organizational data governance or compliance requirements

Be part of a team unlocking strategic impact through advanced analytics, automation, and insight-driven transformation. Shape the way data informs patients’ access and program value across a global organization while enjoying professional growth in a supportive, inclusive culture.

Canyon Labs exists to raise the standard of services in the Medical Device and Pharmaceutical markets by providing streamlined and expert solutions in technical consulting, sterilization, analytical testing and packaging.

We are committed to ensuring that quality services are delivered by meeting or exceeding customer expectations, continuously improving the effectiveness of the quality system, and ensuring compliance with regulations, standards and directives.

Position Title: Chemistry Lab Technician

Location: Onsite at Canyon Labs in Rush, New York

Schedule: Monday – Friday 8:00AM – 5:00PM

Hourly Pay Range: $25.00 - $28.00

Chemistry Lab Technician Job Summary:

We are seeking a highly motivated Chemistry Lab Technician to join our Analytical Chemistry team. The ideal candidate will have hands-on experience with analysis using Gas Chromatography with Flame Ionization Detection (GC-FID), and High-Performance Liquid Chromatography (HPLC). This role involves preparing samples for analysis, performing analytical testing while ensuring accurate and reliable results, maintaining instrumentation, and ensuring compliance with regulatory standards.

Chemistry Lab Technician Key Responsibilities:

• Prepare, extract, and analyze samples for various analytical workflows including chromatography assays, physiochemical analyses, and traditional wet chemistry analyses.
• Support extractables and leachables (E&L) studies following approved protocols and compendial guidance.
• Operate and maintain analytical instrumentation including HPLC, GC, and associated detectors (e.g., UV, FID, MS as applicable).
• Perform routine sample preparation (weighing, dilution, filtration, solvent extraction) with strong attention to trace-level contamination control.
• Conduct analysis for water and medical device testing.
• Prepare and analyze samples according to SOPs, WIs and industry guidelines.
• Maintain accurate and detailed laboratory records, logbooks, lab notebooks, and study documentation.
• Adhere to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) where applicable.
• Support method development and validation for new analytical procedures.
• Ensure compliance with FDA, USP, ISO, ICH, and other regulatory guidelines.

Chemistry Lab Technician Qualifications & Skills:

• Education: Bachelor’s degree in Chemistry, Analytical Chemistry, Biochemistry, or a related field.
• Experience:
• Proficiency in GC-MS/FID and HPLC-UV-MS analysis (MS preferred but not required).
• Familiarity with sample preparation techniques and data interpretation.
• Knowledge of GLP/GMP regulations and laboratory best practices.
• Strong problem-solving skills and attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Strong organizational and communication skills.

Chemistry Lab Technician Preferred Qualifications:

• Prior experience in a pharmaceutical, environmental, or industrial analytical lab.
• Experience with chromatography instrument software for GC-FID, TOC, and ICP-MS.
• Understanding of method validation, USP/NF, and ICH guidelines.

Canyon Labs offers several benefits as part of your total compensation, including but not limited to:

• Paid Time Off, Sick Time, and Paid Holidays
• Medical, Dental and Vision Insurance
• Long term disability insurance, life insurance
• 401(k) with company match up to 4%

At Canyon Labs, we are committed to creating a diverse and inclusive workplace. We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other protected characteristic under applicable laws.