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Job Title: DevOps Engineer

Location: Westborough, MA (Hybrid – Tues/Wed/Thurs onsite)

Type: 6 months Contract

Work Authorization: W2 only

Interview Process: 2 rounds (Zoom, no onsite)

Overview

We are seeking an experienced DevOps Engineer to support cloud infrastructure, CI/CD pipelines, and deployment automation across a diverse enterprise environment. This role focuses on improving application reliability, scalability, and operational efficiency through modern DevOps practices and tooling.

You will work across AWS and Azure environments, supporting cloud-native deployments, integration platforms, and custom applications.

Key Responsibilities

• Design, build, and maintain CI/CD pipelines using GitHub Actions, Jenkins, and Ansible
• Develop standardized deployment pipelines for applications, infrastructure, and integration platforms (MuleSoft, ODI)
• Build and manage cloud infrastructure using Terraform and Infrastructure as Code (IaC)
• Support containerized environments using Docker and Kubernetes (EKS)
• Automate deployment and operational workflows using Ansible (YAML, Playbooks) and Python scripting
• Enable DevOps best practices across applications, integrations, and backend services
• Monitor and improve system reliability, performance, and deployment processes

Required Qualifications

• 6–8+ years of experience in DevOps, CI/CD, and cloud infrastructure engineering
• Strong experience with AWS and Azure
• Hands-on experience with Ansible (YAML, Playbooks) and Python scripting
• Experience with Terraform (IaC) and cloud automation
• Experience with Kubernetes (EKS) and containerization (Docker)
• Experience with Jenkins and/or GitHub Actions
• Experience with MuleSoft API integrations and/or Oracle Data Integrator (ODI)
• Strong automation mindset and problem-solving skills

Harness is the AI Software Delivery Platform company, led by technologist and entrepreneur Jyoti Bansal (founder of AppDynamics, acquired by Cisco for $3.7B). Harness has raised approximately $570M in funding and is valued at $5.5B, backed by leading investors including Goldman Sachs, Menlo Ventures, IVP, Unusual Ventures, Citi Ventures, and more. As AI accelerates code creation, the real bottleneck has shifted to everything after the code testing, deployments, application security, reliability, compliance, and cost optimization. Harness brings AI and automation to this \"outer loop,\" helping teams ship software faster while maintaining security and governance throughout the entire software delivery lifecycle.

Powered by Harness AI and the Software Delivery Knowledge Graph, the Harness Platform applies deep context and intelligent automation across the software delivery lifecycle with governance and policy-driven controls embedded throughout the platform.

Over the past year, Harness powered over 185M deployments, 82M builds, 18T flag evaluations, 8M security scans, 9.1B optimized tests, 3T protected API calls, and helped manage $2.8B in cloud spend enabling customers like United Airlines, Morningstar, and Choice Hotels to accelerate releases by up to 75%, reduce cloud costs by up to 60%, and achieve 10x DevOps efficiency.

With a global team across 14 offices and 25 countries, Harness is shaping the future of AI software delivery and we're looking for exceptional talent to help us move even faster.

Harness is looking for sales champions and leaders who are as passionate about building the next great software company as they are about blowing out their numbers every quarter.

• Exceeding your number- Winning new logos
• Forecasting correctly, communicating clearly, aligning brilliantly with the rest of the team
• Not being afraid of being data driven - including using Salesforce and other tools to track your progress
• Managing full sales cycle from prospect to close
• Collaborating with other teams, including sales engineering and sales development

• A proven track record of driving and closing deals
• Account planning and execution skills
• Ability to sell C-Level and across both IT and business units
• Consistent overachievement of quota and revenue goals with a strong W2 track record
• Understands the value of utilizing a strong sales methodology such as MEDDIC when building pipeline and qualifying opportunities
• Proven consultative sales solution skills, including the ability to articulate a clear, concise return on investment value statement
• Ability to maintain a high level of productivity, manage multiple competing priorities, and work effectively under the pressure of time constraints in a fast-paced, complex, collaborative, and team-oriented environment
• Bachelors Degree or equivalent

This role is based in our Boston, MA office.

• Competitive salary
• Comprehensive healthcare benefits
• Flexible Spending Account (FSA)
• Employee Assistance Program (EAP)
• Flexible Time Off and Parental Leave
• Quarterly Harness TGIF-Off / 4 days
• Monthly, quarterly, and annual social and team-building events
• Recharge & Reset Program
• Monthly internet reimbursement
• Commuter benefits

The OTE for this position is $220,000. Factors that may be used to determine your actual pay rate include your specific skills, experience, qualifications, location, and comparison to other employees already in this role. In addition to the base salary, certain roles may qualify for a performance-based incentive and/or equity, with eligibility depending on the position. These rewards are based on a combination of company performance and individual achievements. A valid authorization to work in the U.S. is required.

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• Directly supervise and train manufacturing staff of the assigned area.
  
• Lead, coach, and support the team's growth to reach maximum throughput.
  
• Conduct daily standup meetings, discussing goals, needs, and solutions.
  
• Prepare daily reports against planned manufacturing targets.
  
• Ensure all leads have the necessary materials, tools and documents are adequate for an upcoming shift.
  
• Identify areas of improvement and collaborate cross-functionally on solutions.
  
• Enforcement of OSHA standards and corrective action.
  
• Perform 7S and Lean projects.
  

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• A minimum of 5 years of experience in a component (CNC) manufacturing environment.
  
• Experience leading a team within a CNC manufacturing environment for machining, deburring and assembly.
  
• Experience in manufacturing for the Aerospace industry
  
• Self-motivated, hands-on, with a practical mindset, and capable of setting and reaching ambitious goals.
  
• Proficient in the use of Microsoft Office Suite Software, ERP Systems (EPICOR), Outlook, and others as needed.
  

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• Bachelor's degree in Mechanical, Systems Engineering or equivalent, or work equivalent.
  
• Excited about taking on new challenges in a fast-paced environment (3D Printing Manufacturing a plus)
  
• Self-motivated, hands-on, practical mindset.
  
• Strong sense of ownership.
  
• High mathematical reasoning and aptitude.
  

The Associate Director, Omnichannel & Marketing Capabilities is a hybrid strategic and technical leader responsible for defining and building the marketing technology infrastructure that powers Galderma's US commercial business. This role acts as the primary bridge between business strategy and technical execution, serving the four major US business units. This individual will lead the design and implementation of the technical roadmap, with a specific hands-on focus on Salesforce Marketing Cloud and Journey Builder to orchestrate complex customer experiences. This high-visibility role will partner closely with Omnichannel Leads, Brand Marketers, and IT to translate commercial vision into a functional reality, ensuring campaigns are data-informed, automated, and scalable.

Location: Boston, MA (Hybrid)

Essential Functions:

Marketing Technology Roadmap & Solution Architecture

• Define and own the technical capability roadmap, translating high-level business requirements from Brand and Omnichannel Leads into specific technical specifications and architectural designs.
• Serve as the primary technical liaison between commercial business units and IT/Global Tech teams to prioritize and implement new platform features, connectors, and integrations.
• Design scalable solution frameworks that allow for \"build once, deploy many\" capabilities across the four Galderma business units to reduce duplication and technical debt.
• Evaluate and recommend new technical tools or plug-ins within the MarTech stack (e.g., SMS aggregators, webinar connectors) to support evolving campaign needs.

Salesforce Marketing Cloud (SFMC) Operations & Execution:

• Serve as the hands-on technical administrator and architect for Salesforce Marketing Cloud, directly managing Journey Builder, Automation Studio, and Contact Builder.
• Build, test, and deploy complex, multi-step customer journeys, utilizing advanced logic (decision splits, engagement triggers) and scripting (AMPscript, SQL) to ensure flawless execution.
• Oversee the end-to-end technical production process, including audience segmentation setup, email/SMS rendering QA, and final deployment scheduling.
• Troubleshoot technical issues within the platform (e.g., API failures, data sync errors, email rendering issues) and resolve them rapidly to minimize business disruption.

Data Activation, CDP & Personalization:

• Lead the technical implementation of Customer Data Platform (CDP) use cases, configuring data ingestion rules and identity resolution logic to create unified customer profiles.
• Develop and maintain the data schema and segmentation logic required to power \"Next Best Action\" and dynamic content personalization across channels.
• Ensure all campaigns are technically configured for accurate measurement from day one, implementing proper tracking tags, parameters, and feedback loops into the data warehouse.

Governance, Vendor Management & Enablement:

• Establish and enforce technical governance standards, including naming conventions, folder structures, and data privacy compliance (consent management/opt-outs) within the platforms.
• Manage the technical output of external development vendors and agencies, reviewing their code and configuration to ensure it meets Galderma's quality and security standards.
• Create and maintain technical documentation (playbooks, data dictionaries, process flows) to support knowledge transfer and operational consistency.

Minimum Education, Knowledge, Skills:

• 8+ years of progressive experience in marketing operations, marketing technology, or digital transformation.
• Deep, hands-on technical proficiency with Salesforce Marketing Cloud, specifically Journey Builder, Email Studio, and Automation Studio.
• Experience in the pharmaceutical, biotech, or healthcare industry is preferred, but not required; experience in highly regulated industries is a plus.

Technical & Functional Skills:

• Proven experience building and managing a marketing technology roadmap and translating business needs into technical specifications.
• Experience implementing or utilizing a Customer Data Platform (CDP) (e.g., Salesforce Data Cloud, Tealium, Adobe) to drive segmentation and personalization.
• Strong understanding of HTML, AMPscript, and SQL basics for audience segmentation and content personalization.
• Demonstrated success in establishing a new capability or function within a complex, matrixed organization.
• Ability to lead through influence, bridging the gap between creative marketers and technical engineering/IT teams
• Strong knowledge of healthcare compliance guidelines, FDA regulations, and privacy standards (PRC process).
• Proven ability to lead through influence and drive change in a complex, matrix-driven organization.
• Experience in capability assessment frameworks and competency modeling.
• Experience managing external agencies and strategic vendors.
• ~10% travel.

Competencies & Abilities:

• Strategic Thinking Shapes training strategy to support commercial objectives.
• Leadership & Influence Inspires and guides peers, field teams, and stakeholders.
• Advanced Instructional Design Builds sophisticated, learner-centered solutions.
• Project & Change Management Leads complex, multi-phase initiatives.
• Analytical Insight Uses data to inform decisions and demonstrate value.
• Innovation & Agility Adopts new approaches and pivots quickly in dynamic markets.

About the Compensation:

The base salary range for this role is determined based on several factors. These include but are not limited to job accountabilities; skill sets; experience and training; certifications; work location; competitive market rates and other business needs. At Galderma, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on a unique combination of factors for each role. A reasonable estimate of the hiring range for this role is $170,000-$210,000.

In addition to base salary, we provide an opportunity to participate in an annual short-term incentive program that is based on corporate performance with a multiplier focused on individual performance. We offer a competitive and comprehensive benefits program including health insurance, 401(k) plan with employer match, a generous paid time off policy, hybrid work schedules and more.

What we offer in return:

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training.

Next Steps:

• If your profile is a match, we will invite you for a first conversation with the recruiter.
• The next step is a virtual conversation with the hiring manager
• The final step is a panel conversation with the extended team

Our people make a difference:

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

Employer's Rights:

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Convergent Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing tumor-selective alpha radio antibodies to target cancer. The company was founded by world-renowned experts in clinical care and research, drug development, and cancer biology, and Convergent’s proprietary platform is licensed from Cornell University. In harnessing the selectivity of antibodies and tumor-destructive potential of alpha radioisotopes, Convergent's radio antibodies precisely target cancer cells with potent, localized radiation.

In addition to the roles and responsibilities outlined below, we value team members who are eager to make an impact and grow with us professionally. We are seeking an individual who enjoys multi-tasking and has the willingness and flexibility to assume additional responsibilities as assigned.

Location: 50 Milk Street, Boston, MA

Reporting to: Caitlyn Harvey, SVP of Technical Operations

Responsibilities

• Create a strategy and lead the MSAT function through CPI, Phase 3 IND submission, PPQ and CPV (this includes API, Drug Substance, and Drug Product).
• Lead technology transfers and author technical documents including reports, standard operating procedures, master batch records, work instructions
• Collaborate with the Development Lead to learn and document the process as well as co-author development protocols and development technical reports.
• Responsible for authoring key IND updates and justifications
• Responsible for authoring MVP
• Provide onsite support at the CDMO, develop a training plan for manufacturing operators, and oversee process execution
• Lead investigations to troubleshoot process execution challenges including RCA
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment

Requirements

• BS and/or MS in Chemical, Biological, or Biomedical Engineering
• 10+ yrs or equivalent combination of education and work experience
• Experience authoring IND sections
• Previous experience with antibody based drug substances and antibody-drug-conjugates
• Detail-oriented with good problem-solving, technical writing and verbal communication skills
• Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment
• Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator.
• Working knowledge of statistical design of experiments (DoE) and RCA.
• Excellent technical writing skills
• Ability to travel up to 25% of the time
• This is a Hybrid role, in office 2 to 3 days a week
• We are considering Greater Boston based candidates only

Nice to haves:

• Knowledge of radiochemistry
• Understanding of analytical methods such as HPLC, SPR, and cell based assays.
• Experience developing scale down models

Equal Opportunity Employer

We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law.

Quality Manager – Direct Hire | 1st Shift

Chelmsford, MA

1st Shift

Direct Hire

About the Role

We are seeking an experienced Quality Manager to lead all Quality operations within a growing aerospace/advanced manufacturing environment. This role oversees quality systems, compliance, audits, supplier management, documentation, and continuous improvement initiatives. The ideal candidate brings strong leadership, deep understanding of AS9100, and the ability to drive a high‑performing quality culture.

Responsibilities

• Lead and develop the Quality team through coaching, training, performance reviews, and career planning.
• Manage and maintain all aspects of the Quality Management System (QMS), including AS9100 compliance, audits, and procedure updates.
• Oversee monthly/annual metrics, documentation control, ECO processing, and risk & opportunity tracking.
• Manage CAPA processes (customer, supplier, internal), NMR/MRB workflows, and GIDEP alerts.
• Serve as the primary quality interface for customers and suppliers, supporting reviews, issue resolution, and status updates.
• Support RFQ and Contract Review processes by validating requirements, flow‑downs, QA codes, and risk entries.
• Oversee supplier approvals, certification tracking, site visits, and quarterly supplier ratings.
• Manage calibration systems, PM documentation, government property equipment logs, and inspection activities (incoming, in‑process, final).
• Support NIST/CMMC compliance with IT and complete actions related to infrastructure and cybersecurity.
• Conduct new‑hire onboarding and coordinate training with HR and Manufacturing leadership.
• Maintain compliance with NAVSUP GFP requirements and conduct monthly walk‑around assessments.
• Drive continuous improvement across all quality processes and cross‑functional operations.

Minimum Requirements

• Bachelor’s degree in Business, Engineering, or related field
• 10+ years of relevant experience
• Strong written and verbal communication skills
• Analytical problem‑solving skills
• Background in Total Quality Management and process improvement
• IPC certifications a plus
• Ability to travel to customer sites as needed
• Attention to detail and strong organizational ability
• Experience in printed circuit boards or related manufacturing preferred

**This role covers the Front End process: Highly Automated Forge and Foundry **

Salary Expectations:

-125-140k

-25% bonus

Keys to this role:

-High manufacturing IQ

-24/7 operation 3 shifts 25 union employees with 3-6 operators per shift.

-Must be a data driven leader

-Must have some sort of forge or foundry experience

PURPOSE:

Manage the Front-End Manufacturing activities for the Worcester, MA facility. Assure that production variable cost and productivity goals are met or exceeded. Improve on-time delivery to customers to targeted level. Adhere to process control/quality criteria so as to reduce rework and scrap. Manage fixed and variable budgets. Full P&L Responsibility for the Isothermal Forge Shop and mult prep.

ESSENTIAL JOB FUNCTIONS:

• Coordinate and manage a full complement of production and production support activities.
• Interface and work with key staff positions: Materials Management, Product Engineering, Quality, Accounting, HR, IT, etc.
• Drive cost reduction and continuous improvement in the attainment of corporate goals.
• Responsible for cost control and budget attainment.
• Meet required customer shipping schedules.
• Establish working effective relationship with Union leadership.
• Establish and execute capital planning efforts supporting manufacturing

With more than 100 years of experience, Sika is a worldwide innovation and sustainability leader in the development and production of systems and products for commercial and residential construction, as well as the transportation, marine, automotive, and renewable energy manufacturing industries.

Sika is a specialty chemicals company with a globally leading position in the development and production of systems and products for bonding, sealing, damping, reinforcing, and protection in the building sector and industry. Sika has subsidiaries in 103 countries around the world, produces in over 400 factories, and develops innovative technologies for customers worldwide. In doing so, it plays a crucial role in enabling the transformation of the construction and transportation industries toward greater environmental compatibility. Approximately 33,000 employees generated CHF 11.20 billion in sales in 2025.

Sika is looking for an experienced Production Supervisor to join its growing team in the Canton, MA area for our Roofing business.

The A Shift Supervisor will support a team of 10 Machine Operators and will work 6am- 6pm Su, Mon, Tues and every other Wednesday.

Salary Range: $30 - $35/hour with a 10% shift differential based on education, experience and qualifications of the applicant

• Assign responsibilities to employees and oversee their development
• Ensure that employees are operating in a safe manner and that they adhere to all Sika, OSHA, and other regulatory requirements
• Periodically audit employees on their job functions and work with them to help develop their skills
• Work with management and engineering regarding coordination of raw material and process equipment trials
• Submit work orders to the Fiix CMMS system and follow through with verbal communication to maintenance technicians regarding said work orders
• Ensure that all team members are engaged in Sika Safe
• Collect daily production sheets from the Lead Operator, Mixer Operator, and Extruder Operator and document them accordingly. Reconcile any variations in MES system
• Work with quality assurance to ensure that the membrane produced meets all ASTM and local guidelines
• Foster a positive work environment through active communication and transparency with employees
• Communicate the daily/weekly production schedule with team in mandatory daily shift starter meetings
• Encourage team to maintain clean work areas using 6S principles
• Meet regularly with Production Manager and planning team to ensure that the proper materials/resources are in place for successful, on-time manufacturing
• Communicate daily results to the management team through shift report email
  
  

• 5+ years of supervisory experience in continuous manufacturing
• High School Diploma/GED
• Proficient in computers and MS Office (Word, Excel, Outlook)
• Some experience using SAP or ERP system recommended
• Excellent verbal and written communication skills
• Proven ability to work in a team environment
• The ability to coordinate product changeover on short notice
• Some extrusion, spreadcoating, and/or dry blending knowledge is preferred
• Ability to operate a forklift
• Ability to stand for extended durations
• Ability to lift 50 lbs
  
  

• 401k with Generous Company Match
• Bonuses
• Medical, Dental, and Vision Benefits
• Paid Parental Leave
• Life Insurance
• Disability Insurance
• Paid time off, paid holidays
• Floating holidays + Paid Volunteer Time
• Wellness/Fitness Reimbursements
• Education Assistance
• Professional Development Opportunities
• Employee Referral Program & More!

Sika fosters a culture of entrepreneurship, empowering each individual to make decisions, learn from experiences, and shape their own career path. The safety and well-being of employees are top priorities at Sika, with a strong commitment to open communication and maintaining a safe workplace. In addition, Sika actively contributes to the community and promotes sustainability by giving back, minimizing environmental impact, and embracing social responsibility.

Sika Corporation is committed to a work environment that supports, inspires, and respects all individuals that apply. As an equal opportunity employer Sika will consider all qualified applicants without discrimination on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, age, disability, national or ethnic origin, or other protected characteristics.

Sika Corporation is committed to a work environment that supports, inspires, and respects all individuals that apply. As an equal opportunity employer Sika will consider all qualified applicants without discrimination on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, age, disability, national or ethnic origin, or other protected characteristics.

We offer competitive salaries, aligned with local market benchmarks and the specific scope and responsibilities of each role. Compensation is determined based skills relevant to the position, education and/or training. We are committed to fair and equitable pay practices in accordance with applicable laws and regulations.

Salary Range: 65k-95k

Title: Materials Management Specialist/Senior Materials Management Specialist

Location: Woburn, MA (on-site 5 days per week)

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Role: 

Works under the operations team and in coordination with the Quality Assurance (QA) team to oversee the entire flow of materials, from procurement and inventory control to receipt to storage and distribution. Ensure all materials meet defined specifications and are available for intended use and quantities to support user needs. Provide continuous improvement efforts in purchasing, planning, and warehousing. Key responsibilities include strategic sourcing, inventory optimization, demand forecasting, supplier negotiation, and managing logistics for clinical distribution while reducing waste and costs.

Responsibilities: 

• Develop material strategies, forecasts demand, plans production and inspection schedules, and aligns material flow with business goals.
• Maintains optimal inventory levels, conducts physical counts, investigates discrepancies, and implements lean manufacturing principles.
• Supervises purchasing, inventory, and warehouse activities in a manner consistent with cGMPs.
• Assists Quality Assurance to assign and document the status for all materials used in the development of Vaxess products.
• Implements initiatives to reduce waste, cost efficiencies, and improve financial performance.
• Sources, negotiates, and purchases goods and services, building strong supplier relationships and ensuring quality and reliability.

Qualifications: 

• 2 to 5 years in Material Management or Shipping and Receiving in the Pharmaceutical or Medical Device Industries working in a cGMP Environment.
• Strong understanding of supply chain, logistics, and inventory principles.
• Experience with ERP Systems/SAP preferred.
• Experience with standard cGMP storage requirements for Quarantine, Release and Rejected materials.
• Experience with the receipt, storage, distribution, and shipping of temperature-controlled materials.
• Bachelor’s Degree in a relevant field (Logistics, Biomedical Engineering or Health Care Management and certifications (APICS, ISM) preferred.

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to   

Immediate need for a talented Scientist I. This is a 12+ Months contract opportunity with long-term potential and is located in Waltham, MA, USA(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job Diva ID: 26-08545

Pay Range: $ 46-$56 /hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology
• Lead and conduct viral/non-viral vector purification process development and process analytics
• Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology
• Develop, conduct, maintain analytical assays such as ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS etc. for in-process sample testing to support process development
• Provide scientific and technical expertise for in-process sample testing activities, including product quality and process impurity methodologies
• Perform troubleshooting experiments and communicate findings with appropriate working groups
• Maintain industry knowledge and keep abreast of new and relevant technologies
• Perform data analysis, contribute to technical reports, external publications, patent applications and internal/external presentations
• Lead scale-up activities to implement a manufacturing process based on DSP development knowledge
• Communicate effectively with internal and external teams, e.g. CDMOs for tech transfer activities
• Mentor and support junior staff and build a culture of support and collaboration

Key Requirements and Technology Experience:

• Key skills: - Purification experience/ Protein Purification Chromatography
• Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, - Late-stage purification experience such as design space mapping and process robustness studies
• PhD in Biotechnology, Biochemistry, Chemical Engineering or related discipline or master’s degree with a minimum of 4 years of relevant experience or a bachelor’s degree with a minimum of 6 years of relevant experience
• Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS
• Significant experience, knowledge and understanding of purification technologies and operations such as:
• Filtration unit operations at various scales, including depth filtration, tangential flow filtration, etc.
• Protein purification chromatography
• Virus clearance and inactivation
• Familiarity with advanced purification technologies and process analytical technologies
• Familiarity with analytical method transfer, analytical method bridging across organizations
• Experience with process technology transfers and performing gap analyses and risk assessments
• Understanding of critical quality attributes and the principles of Quality by Design and ability to apply DOE to downstream development
• Expertise in technical report writing
• Experience in AAV and/or non-viral purification development
• Experience in writing CMC components of regulatory dossiers
• Knowledge of product comparability, target product profile and quality risk assessment activities
• Viral clearance study design and execution
• Late-stage purification experience such as design space mapping and process robustness studies
• Ability to work in Biosafety Level 2, follow safe lab procedures and maintain good laboratory practices (GLPs)
• Ability to work under minimal supervision and function within a collaborative, team-oriented environment
• Excellent organization and communication skills
• Innovative, critical and creative thinker, unafraid of proposing aggressive solutions to complex problems
• Experience with biophysical characterization
• Experience in continuous manufacturing and process analytical technology
• Experience in mentoring junior staff
• Ability to build and nurture cross-functional relationships
• Ability to communicate and represent group in diverse, multi-functional meetings

Our client is a leading Pharmaceuticals industry , and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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