Codashop, PH Jobs in Usa

This is a six month assignment in Vacaville

This potsition is for local candidates as there is no travel and living expenses

This is a W2 Position.

Process Engineer I

Summary:

This position is located at Lonza’s production facility in Vacaville, California. The production facility makes pharmaceutical proteins from mammalian cells using large-scale production techniques. This temporary contract position provides hands-on technical support for Process Analytical Technology (PAT) systems deployed on the manufacturing floor at a large-scale biopharmaceutical facility. PAT systems play a critical role in monitoring mammalian cell culture processes by measuring key parameters such as cell density, viability, and metabolite concentrations. Maintaining these systems in a reliable, ready-to-use state is essential for ensuring consistent manufacturing performance.

In this role, you will support day-to-day operation, maintenance, and troubleshooting and repair of PAT instruments used in GMP manufacturing. You will work closely with the Frontline Upstream (FLUS) System Owner, Manufacturing, and Instrumentation staff to assess system issues, perform equipment health checks, execute planned improvements, and assist with investigations into unplanned events. This position supports the increased workload associated with the deployment of several new PAT systems in parallel with existing instruments. This position offers the opportunity to gain hands-on experience with advanced PAT used to support mammalian cell culture and purification operations. The FLUS and Instrumentation groups provide technical support for a wide range of analytical instruments used to monitor cell growth, metabolite profiles, and process performance throughout the manufacturing lifecycle.

Job Duties:

Responsibilities/activities may include, but not limited to:

• Performing routine maintenance, calibration checks, and system readiness activities for PAT instruments such as cell counters and metabolic analyzers (e.g., Cedex Bio, Cedex HiRes, Cedex Cobas).

• Supporting manufacturing operations by responding to system-related issues, troubleshooting instrument performance, and documenting observed problems.

• Assisting in the investigation of unplanned equipment events using structured problem-solving tools and contributing to root cause assessments.

• Conducting equipment health monitoring and contributing to reliability improvement activities to increase system uptime.

• Executing planned equipment changes, minor upgrades, and configuration updates under the direction of the PAT System Owner.

• Reviewing and interpreting instrument data to identify basic trends or abnormalities.

• Supporting adherence to data integrity principles and helping maintain data consistency within systems such as Smartline Data Cockpit.

• Collaborating with Manufacturing, FLUS, Automation, QA, and vendors to ensure systems are functioning as intended.

• Assisting with documentation updates, tracking of work activities, and preparing technical summaries as needed.

• Working independently to accomplish assigned tasks while keeping stakeholders informed of progress.

Education and Experience:

• B.S., M.S., or Ph.D in an engineering or analytical/scientific discipline.

• Prior hands-on experience with analytical systems is required.

• Experience using cell counters and metabolite analyzers (Cedex Bio, Cedex HiRes, Cedex Cobas) in GMP Manufacturing or QC Labs preferred.

Knowledge/Skills/Competencies:

• Working knowledge of current Good Manufacturing Practices (cGMPs) as applied to biopharmaceutical manufacturing or similar regulated industries.

• General understanding of biotech analytical methods and laboratory practices.

• Experience troubleshooting analytical instruments and interpreting equipment performance data.

• Flexibility in problem solving and work hours to meet business objectives.

• Familiarity with data management systems; experience with Smartline Data Cockpit is highly desirable.

• Strong interpersonal and communication skills; able to work effectively with operators, engineers, scientists, and external vendors.

• Ability to work independently and manage assigned tasks with limited supervision.

• Demonstrated ability to evaluate technical situations, propose solutions, and execute corrective actions.

• Strong verbal and written communication skills, including documentation, reporting, and stakeholder updates.

• Ability to build productive working relationships with end users and equipment vendors.

• Strategic thinking mindset with the ability to convert system needs into actionable activities.

• Builds productive relationships with partners; focuses on customer needs.

Our pharmaceutical client is seeking a Principal Scientist who will be responsible for evaluating and interpreting analytical results, as well as developing, validating, and transferring analytical methods for APIs, intermediates, and raw materials. If you are someone who wants to be apart of a highly technical environment with a lot of growth, this role may be the one for you!

Responsibilities:

• Safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products
• Actively participate in teams assembled to investigate and solve analytical technical issues within Analytical Development, Chemical Development, Process Support Group and Quality Control.
• Perform analytical chemistry assays based on new and existing methodologies
• Operate analytical instrumentation such as HPLC, GC, GC/MS, FTIR, Titrator, Particle Size Analyzer
• Write technical reports to document analytical methods
• Maintain laboratory notebooks documenting work
• Maintain compliance with GMP SOPs and DEA regulations
• Transfer documented analytical methods to the QC and Process Support Group departments
• Set up new or existing analytical methods for compound identification, purity and potency testing.
• Coordinate off-site testing as necessary
• Conduct testing of analytical samples for the Chemical Development Department as needed.
• Qualify reference materials.
• May also perform other duties as required.

Qualifications:

• Ph.D. in Chemistry or related field with minimum 6 years of experience or M.S. in Chemistry or related field with minimum 10 years of experience or B.S. degree in Chemistry or related field with 14 years of experience in lab environment, pharmaceutical experience preferred.

SciPro has partnered with an early-stage life sciences startup developing a novel approach expected to significantly increase the sensitivity of liquid biopsy testing. Their proprietary method enables at-home collection of cfDNA through a non-invasive process.

In addition to being faster, easier, safer, and more cost-effective than traditional clinical blood draws, this approach may provide substantially greater cfDNA yield. Potential applications include oncology, maternal & fetal health, transplant monitoring, and other areas of diagnostic and disease monitoring.

Their mission is to enable better diagnostic insights and ultimately improve patient outcomes through enhanced biological sampling.

They are currently hiring for two positions and both roles will play key parts in advancing ongoing scientific programs. These are full-time, onsite laboratory roles suited for entry-level through experienced Ph.D. scientists.

Responsibilities include:

• Designing and conducting experiments
• Preparing research reports
• Collaborating with internal teams, academic core labs, and external partners

Qualifications

• BS, MS or PhD in biology, genetics, or a related field. Industry experience preferred.
• Experience isolating DNA
• PCR experience (ddPCR strongly preferred)
• Experience with NGS and low pass sequencing in particular
• Hands-on laboratory experience and desire to remain hands-on
• Proven ability to contribute to scientific research projects
• Experience troubleshooting and executing cfDNA analysis

Core Competencies

• Accountability and ownership
• Strong laboratory knowledge (DNA, cfDNA, PCR, NGS; ddPCR a plus)
• Sound decision-making
• Adaptability in fast-paced environments
• Problem-solving and analytical thinking

• Develop, implement, and evaluate a management action plan on an annual basis, assuring quality EAP service delivery and manageable growth
• Prepare the annual program budget and monitors expenses monthly
• Develop and implement standard operating procedures and practices for EAP service delivery that ensure client confidentiality and timely, ethical, and quality service
• Establish and maintain effective and confidential record keeping and data management reporting systems
• Evaluate EAP process and outcome in terms of utilization, quality of services provided, and attainment of program objectives
• Establish and monitor a network of community organizations and resources
• Participate in professional EAP organizations and provide consultation regarding EAP practice to the community
• Supervise the delivery of assessment, referral, and short-term problem resolution, follow-up, and return-to-work services to employees/families who need assistance
• Consultation is provided to sponsoring work organizations regarding the development of policies and procedures related to EAP services including alcohol and drug policy, drug testing, and organizational response to the critical incidences
• Provide timely and quality training and consultation services to managers regarding troubled employees
• Provide direct supervision of EAP staff
• Other duties as assigned
  

• Master's degree and North Carolina Licensure in a clinical human services discipline, i.e., counseling, social work, psychology, etc. (LCSW, LPC, LPA or Ph.D.) required
• Clinical licensure as required by state
• Certified Employee Assistance Professional preferred
  

• 5 years’ experience is required including two or more of the following areas: EAP services, outpatient mental health, alcohol and/or chemical dependency treatment, inpatient psychiatric practice, and private psychotherapy practice
• 5 years’ administration/management experience required
  

• Knowledge of core EAP services, clinical assessment skills including alcohol/drug assessment and intervention, clinical supervision skills, consultation skills,
• Knowledge of human resources functions, budget preparation, contract management
• Excellent verbal and written communication skills
• Comprehensive EAP background in all aspects of programming
• Familiarity with computer systems, and management information procedures
• Ability to function autonomously
• Effective time and resource management
• Concern for service quality and customer satisfaction
  

• Must be able to move about multiple facilities.­
  

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

We are seeking a motivated and detail-oriented Research Associate with strong hands-on experience in chromatographic analysis to support QC release and stability testing. The successful candidate will perform routine cGMP QC testing using HPLC methods (RP-HPLC, SEC, IEX), Agilent HPLC systems, and additional supporting assays in a fast-paced, collaborative environment. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.

Key Responsibilities

• Perform routine QC release and stability testing using HPLC methods including RP-HPLC, SEC, and IEX.
• Prepare samples, operate Agilent HPLC systems, verify system suitability, and ensure analyses meet method and specification requirements.
• Execute complementary analytical assays such as UV-Vis, pH, surface tension, and mechanical tests.
• Maintain complete, accurate documentation in compliance with cGMP, ALCOA+, and data integrity requirements.
• Conduct routine instrument care (solvent flushes, column care, daily checks) and assist troubleshooting under supervision.
• Process and review chromatographic data in Agilent OpenLab CDS.
• Support method qualification, validation, and transfer activities by executing protocols and recording observations.
• Maintain calibration, maintenance, and service records for analytical instrumentation.
• Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
• Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success.
• Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
• Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related field with 1–3 years of experience; or a master’s degree with relevant laboratory experience.
• Hands-on experience operating HPLC systems; Agilent systems and OpenLab CDS experience strongly preferred.
• Practical experience with chromatographic techniques including RP-HPLC, SEC, and IEX.
• Experience supporting QC release or stability testing in a GMP/GLP environment.
• Strong attention to detail and ability to follow SOPs precisely.
• Excellent documentation practices and understanding of data integrity.
• Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment.
• Excellent verbal and written communication skills and comfort working within interdisciplinary teams.
• Commitment to collaborative work within interdisciplinary project teams.

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

Industry: Pharmaceuticals

Title: Senior Associate Scientist

Job ID: CAMB000120

Location: Cambridge MA

Duration: 03 months contract (+Possibility of extension)

Skill Set - Oligonucleotide synthesis and downstream processing, Analytical HPLC/LCMS/UV-vis

Summary of Key Responsibilities

• Hands-on lab support and process development for the chemical synthesis and downstream processing of oligonucleotide-based drug substance

• Synthesis of oligonucleotides up to 11 mmol scale

• Downstream processing of oligonucleotides including prep-HPLC, Ultrafiltration, annealing, concentration and Lyophilization

• In process analytical testing including AX-HPLC, IPRP-HPLC, LCMS, UV-vis

• Technical support for optimization of contract manufacturing processes

Qualifications

• BS in Chemistry with 3+ years lab experience, preferably in an industrial setting.

• Basic understanding of analytical techniques (pH, osmolality, conductivity measurement, HPLC, LC-MS etc.).

• Related hands-on experience is preferred. Knowledge of oligonucleotide manufacture process including phosphoramidite chemistry, chromatography, ultrafiltration etc. is a plus.

• Experience in record-keeping and excellent laboratory documentation practice, are required. Strong commitment to high laboratory and scientific standard; ability to maintain a safe, clean, and orderly laboratory work environment; assist in routine lab and equipment maintenance.

• Good communication skills are a must for this position. The successful candidate must be a responsible and proactive individual who is able to work as a team player in a highly dynamic environment with aggressive timelines.

Responsible for the dispensing of raw materials liquids and powders (hazardous and non-hazardous), acids/bases, under cGMP conditions to support the manufacture of therapeutic proteins (API)

Individual will be required to perform and monitor all dispensing processes and weighs, including liquid, powder (hazardous and non-hazardous), acids and bases. All processes will be completed per cGMP guidelines to support the manufacture of therapeutic proteins (API).

• Required to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique and cross contamination awareness in handling of products and materials.

• Expected to follow and adhere to all written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, and sampling as required. All tasks will be completed while gowned and wearing required PPE while working in a Class C environment.

• Expected to execute process recipes.

• Ability to qualify for all assigned tasks and maintain individual training plan.

• Ability to qualify and perform required functions and scheduled cleans on all Dispensing equipment through routine cleaning and sanitization.

• Perform peer, First Level Reviews of completed eDispense orders/kits, upon completion of WBT and LQM/PM signoff by area trainer.

• Ability to report to production via written and electronic documents in accordance with current good manufacturing practice (cGMP) and good documentation practice (GDPs). Complete documentation reviews as appropriate.

• Prepare materials for transport and delivery to manufacturing suites. Perform material movements both physically and in software systems.

• Participate in Safety Inspections and submit safety observations to provide safer working conditions for self and others.

• Administrative tasks to include attendance at shift exchange and required meetings, sending/receiving of emails, and participation in assigned projects.

• Performs other duties as they are assigned to support Logistics Team.

Associates Degree and/or equivalent experience

JOB OVERVIEW:

The Validation Scientist position encompasses all areas of Technical Services with primary focus on technology transfer, scale-up, process optimization, process/packaging validation, commercial production technical support as well as equipment qualification and cleaning validation support.

KEY ROLES/RESPONSIBILITIES:

• Lead and execute projects such as technology transfer, scale-up, process optimization process/packaging validation as well as equipment qualification and cleaning validation support to meet critical project deadlines.
• Provide technical support in the investigation of manufacturing incidents and major deviations. Assure thoroughness of investigation and documentation as well as implementation of preventive/corrective actions as necessary.
• Conduct commercial production technical support activities such as qualification of alternate suppliers of API, excipients and packaging components, equipment change parts, process parameters, yield limits, hold time studies, etc.
• Execute utility and process equipment qualification support activities such as installation, operational and performance qualifications, periodic reviews, investigations, assessments, review change control and non-routine maintenance requests, out of specification calibrations, etc.
• Perform cleaning validation support activities such as execution of cleaning validation and verification studies, hold time studies, investigations, assessments, justifications, maintain cross contamination program, etc.
• Develop and/or execute experimental designs and approaches to resolve technical problems and utilize engineering standards, principles, concepts, equations as well as statistical techniques.
• Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, justifications, investigation reports, regulatory submissions, master batch records, change control, etc.
• Complete and document physical sampling and testing such as loss on drying, particle size distribution, bulk density, viscosity, pH, tablet weight, thickness, hardness and friability; sample for analytical and microbiological testing.
• Author and periodically update assigned Standard Operating Procedures (SOPs) for the department.
• Represent Technical Services at project team meetings and provide sound technical advice.
• Coordinate and interface with Operations, Facility Engineering, Quality Control, Quality Assurance and Regulatory Affairs groups to assure successful project execution.
• Directly interact with Piramal Pharma Solutions clients.
• Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures.

EXPERIENCE:

• Minimum of a Bachelor's degree in a scientific discipline (e.g., Chemical Engineering, Pharmaceutics, Pharmacy, Chemistry or equivalent) with a minimum of 3 years experience in Technical Services, Process Engineering, Process Validation, Formulation or related field in the pharmaceutical industry.
• Experience in laboratory and production scale manufacture of solid oral, liquid and semi-solid dosage forms using equipment such as comminuting mills, high-shear granulators, fluid bed dryers, blenders, tablet presses, tablet film coaters, encapsulates, low and high-shear mixing vessels, homogenizers, pumps, packaging, etc.
• Working knowledge of cGMP (Current Good Manufacturing Practices) regulations, SUPAC guidance, and general compliance expectations.
• Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment impact evaluation, and technical report writing.
• Must possess research and problem solving abilities and be capable of producing detailed documentation, understand and make generalized and specific conclusions from project data.
• Technical writing experience is required with attention to detail skills essential.
• Must be able to work in a team environment with effective project planning/management, analytical thinking, organization, and execution skills.
• Must have proficiency in the Microsoft Office Suite programs.
• Demonstrated professionalism and excellent communication skills with internal and external personnel are essential.
• Ability to work effectively managing multi projects at a fast pace withcross-functional departments and manage priorities to meet timelines.
• Must be innovative, proactive, resourceful and committed to continuous improvement.
• Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred.

WORK ENVIRONMENT:

The position requires the ability to work in ahigh demand office and manufacturing setting with time spent performing "on the floor" activities in laboratory and manufacturing areas. The position may require extended hours including evenings and weekends as well as work hours on 2nd and 3rd shifts depending on project needs.