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Qualifications include a PhD or equivalent with experience in immunogenicity assays, GLP/GCP practices, assay transfer, and data analysis. Responsibilities include collaborating with research and development teams, ensuring assay compliance with regulatory guidelines, and supporting regulatory submissions.

Seeking a Principal Scientist in Immunogenicity Bioanalytical Sciences to lead the development, validation, and transfer of assays for detecting anti-drug antibodies (ADAs & NAbs) in large molecule therapeutics. Responsibilities include collaborating with research and development teams, ensuring assay compliance with regulatory guidelines, and supporting regulatory submissions. Qualifications include a PhD or equivalent with experience in immunogenicity assays, GLP/GCP practices, assay transfer, and data analysis. Preferred skills involve expertise in immunogenicity assay formats, statistical methods, and team mentorship. The role offers competitive compensation, benefits, and professional growth opportunities, with an emphasis on collaboration and innovation. The organization values diversity, inclusion, and a commitment to serving patients worldwide.

At Amgen, we believe in a “biology first” approach. We use cutting-edge science and technology to study the subtlest biological mechanisms in search of therapies that will improve the lives of those who suffer from serious diseases. Amgen believes the cure for disease can be found inside each and every one of us.

Amgen

Principal Scientist - Immunogenicity Bioanalytical Sciences

Antibodies

Assays

Data Analysis

Diversity

GCP (Good Clinical Practices)

GLP (Good Laboratory Practices)

Maintain Compliance

Mentoring

Regulatory Compliance

Regulatory Submissions

Research & Development (R&D)

IRecruitee

The position involves teaching face-to-face or online classes, maintaining accurate records, and contributing to a diverse and inclusive educational environment. Candidates will deliver classroom instruction, assess student performance, develop course materials, and participate in curriculum and program development.

This part-time faculty position at Ventura College offers ongoing opportunities for instructors in biological sciences for the Fall 2026 semester. Candidates will deliver classroom instruction, assess student performance, develop course materials, and participate in curriculum and program development. The role requires a master's degree in biological sciences or equivalent qualifications, with experience in microbiology preferred. Applicants must submit a complete application package, including transcripts, a cover letter, and optional recommendation letters, through an online system. The position involves teaching face-to-face or online classes, maintaining accurate records, and contributing to a diverse and inclusive educational environment. Compensation ranges from $2,408 to $3,108 per semester per 10% load, governed by collective bargaining agreements. The district emphasizes equity, accessibility, and support for applicants requiring accommodations.

Ventura County Community College District

Instructor in Biological Sciences, Initial focus: Microbiology (Part-Time Pool)

Biology

Course Development

Microbiology

Performance Analysis

Training/Teaching

Training/Teaching Curriculum

Training/Teaching Materials

OTHER

HOUR

Fusion Academy

Math and Science Teacher

Algebra

Anatomy

Astronomy

Calculus

Chemistry

Communication Skills

Corporate Policies

Dental Insurance

Employee Assistance Plan

Geometry

Interpersonal Skills

Life Insurance

Marine Biology

Mathematics

Organizational Skills

Physics

Physiology

Problem Solving Skills

Psychiatry and Mental Health

Record Keeping

State Laws and Regulations

Statistics

Trigonometry

Vision Plan

Zoology

[AW]-iCims

Evaluate process and product performance through analytical testing via measurement of pH, conductivity, osmolality, protein concentration, HPLC and CE methodologies, solid state characterization, particle quantitation/characterization, physical properties, etc. Preferred Qualifications:Bachelors Degree in Engineering, Chemistry, Biochemistry, Pharmaceutics, Materials Science, or related discipline with at least 2+ years of relevant laboratory work experience.

This role in Pivotal Drug Product Technologies will be to provide support of drug product formulation and process development of biologics. The candidate will work closely with a team of engineers and scientists responsible for the technical aspects of the client's drug product commercialization and lifecycle management. Responsibilities:
<ul><li>Participate in the planning, design, execution, and documentation of studies related to drug product formulation and process development in support of commercialization and life cycle management of biologics.</li><li>Support and conduct related studies, e.g. UF/DF, filtration, freeze/thaw and fill/finish, for products in various formulations and formats (liquid, lyophilized, etc.).</li><li>Evaluate process and product performance through analytical testing via measurement of pH, conductivity, osmolality, protein concentration, HPLC and CE methodologies, solid state characterization, particle quantitation/characterization, physical properties, etc.</li><li>Data analysis and documentation/review in electronic notebooks.</li><li>Author, review, and data verify technical documents such as protocols, reports, regulatory documents, etc.</li><li>Clearly and consistently communicate data in progress reports and presentations.</li><li>Participate in cross-functional teams in a fast-paced environment to progress product development.</li><li>Adhere to all training, compliance, and safety guidance.</li><li>Support lab operations and inspections as required of all lab-based staff.</li><li>Work primarily onsite with remote work as appropriate to role and tasks.</li><li>Support and conduct related studies, e.g. UF/DF, filtration, freeze/thaw and fill/finish, for products in various formulations and formats (liquid, lyophilized, etc.).</li><li>Evaluate process and product performance through analytical testing via measurement of pH, conductivity, osmolality, protein concentration, HPLC and CE methodologies, solid state characterization, particle quantitation/characterization, physical properties, etc.</li><li>Data analysis and documentation/review in electronic notebooks.</li></ul>Basic Qualifications:<ul><li>Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience</li></ul>Preferred Qualifications:<ul><li>Bachelors Degree in Engineering, Chemistry, Biochemistry, Pharmaceutics, Materials Science, or related discipline with at least 2+ years of relevant laboratory work experience. Or Masters degree without any experience.</li><li>Understanding of physical/chemical stability of proteins.</li><li>Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with procedures and policies.</li><li>Proficient computer skills, including Microsoft Office, PowerPoint, Word, and Excel.</li><li>Self-motivation, adaptability and a positive attitude.</li><li>Critical thinking, problem solving, and independent research skills.</li><li>Good organizational skills with strong attention to detail.</li><li>Excellent oral and written communication skills.</li></ul>

The Steely Group

Scientist Senior Associate

Biochemistry

Biological Processes

Computer Skills

Cross-Functional

Detail Oriented

Documentation

Drug Products

High Performance Liquid Chromatography (HPLC)

Laboratory

Laboratory Operations

Material Science

Microsoft Excel

Microsoft Office

Microsoft PowerPoint

Microsoft Word

Multitasking

Operational Support

Osmolarity

Performance Testing

Pharmaceutics

Physical Chemistry

Pivotal CRM

Presentation/Verbal Skills

Process Development

Product Development

Product Lifecycle Management

Product Support

Product Testing

Product/Service Launch

Progress Reports

Regulatory Reports

Research Skills

Safety Compliance

Team Player

Technical Writing

Work From Home

Writing Skills

HaleyMarketing

This group performs assays for small molecule and peptide analysis using LC-MS/MS, ELISA assays using MSD and Spectrmax readers and Immunogenicity assays that are Anti-drug antibody and Neutralizing Antibody assays using MSD, Spectramax, Envision and Vicell type readers. Responsibilities:For Controlled Environment Equipment (CEE) which includes freezers, refrigerators, desiccators and Liquid Nitrogen tank), the role would be responsible for the following items: Inventory Manager to build inventory from each type of controlled chambers (e.g., refrigerator, freezer, LN2, Ambient, etc.).

We are seeking a highly motivated and detail oriented individual with strong expertise in life sciences and Laboratory Information Management Systems (LIMS) to support the modernization of the global Bioanalytical Sciences LIMS/ELN ecosystem. 
This group performs assays for small molecule and peptide analysis using LC-MS/MS, ELISA assays using MSD and Spectrmax readers and Immunogenicity assays that are Anti-drug antibody and Neutralizing Antibody assays using MSD, Spectramax, Envision and Vicell type readers. This contract offers the opportunity to contribute to a major digital transformation initiative within a world class scientific organization. 
You will work closely with the global Pharmacokinetics and Drug Metabolism  Bioanalytical Sciences (PKDM BA) team, collaborating with colleagues across sites in California and Germany, as well as with software vendors and internal subject matter experts. Your work will directly shape the implementation of our new LabVantage LIMS/ELN platform and help harmonize data and workflows across our global bioanalytical community. Responsibilities:<ul><li>For Controlled Environment Equipment (CEE) which includes freezers, refrigerators, desiccators and Liquid Nitrogen tank), the role would be responsible for the following items:</li><li>Inventory Manager to build inventory from each type of controlled chambers (e.g., refrigerator, freezer, LN2, Ambient, etc.)</li><li>Build a process with BA lab staff of check-in and checkout of these controlled chambers.</li><li>Tracks products in low temperature, focusing on accuracy, safety, and efficiency by managing receiving, storing, picking, and shipping, conducting cycle counts, resolving discrepancies (like damages/shorts), and generating reports, all while upholding strict health/safety/regulatory standards like FDA.</li><li>BA Operations Oversight: Manage daily inventory flow, including receiving, put-away, picking, packing, and dispatching of goods.</li><li>Inventory Accuracy: Conduct regular cycle counts and full physical inventories; reconcile physical stock with system records.</li><li>Discrepancy Resolution: Investigate and resolve issues like damaged goods, short shipments, missing items, and customer claims.</li><li>System Management: Process adjustments, updating records, and generating reports on inventory levels, movement, and performance.</li><li>Cold Chain Compliance: Monitor and maintain temperature/humidity controls and enforce proper handling to preserve product integrity.</li><li>Safety & Security: Enforce company safety policies, monitor security protocols, and ensure compliance with FDA guidelines.</li><li>Reporting & Analysis: Generate inventory reports and analyze trends to support and process improvements.</li><li>Coordination: Liaise BA lab staff and management to ensure smooth workflow.</li></ul>Master Data Integration<ul><li>Lead the integration of assay and study metadata, reagent and equipment information, and experimental raw data/results from multiple legacy systems into a unified global LIMS environment.</li><li>Builds inventory from each type of controlled chamber (e.g., refrigerator, freezer, LN2, Ambient, etc.) into an inventory management system.</li></ul>Testing & Compliance<ul><li>Contribute to test planning and execution to ensure the LIMS/ELN solution meets specifications, supports bioanalytical workflows, and complies with company standards and regulatory requirements (including GxP and FDA 21 CFR Part 11).</li></ul>Documentation<ul><li>Create and maintain clear, comprehensive documentation covering requirements, processes, data flows, configurations, and user guides.</li></ul>Training & User Support<ul><li>Assist in developing and delivering training to end users adopting the new LIMS/ELN system.</li></ul>Collaboration & Communication<ul><li>Serve as a liaison between PKDM-BA labs (ATO and ASF), research teams, technology teams, and software vendors.</li><li>Foster strong collaboration across diverse groups including bench scientists, data scientists, software engineers, and data engineers.</li></ul> Qualifications & Skills:<ul><li>Bachelors in life sciences, computer sciences, or a related field</li><li>Minimum 2 years of direct experience working with laboratory software and electronic data processes in the pharma/biotech industry.</li><li>Experience in inventory roles, preferably in cold storage or logistics.</li></ul>Regulatory & Quality Knowledge<ul><li>Experience with Laboratory Information Management Systems and Electronica Laboratory Notebooks (e.g., Watson LIMS, StarLIMS, IDBS ELN, Others) would be helpful.</li><li>Experience in GxP environments and understanding of computerized system validation and regulatory frameworks (e.g., FDA 21 CFR Part 58 and part 11) is desired.</li></ul>Soft Skills & Ways of Working<ul><li>Self-driven and consistent demonstration of initiative</li><li>Ability to multi-task activities while maintaining attention to details</li><li>Excellent communication skills</li><li>Strong analytical, organizational, and problem solving abilities.</li><li>Demonstrated success collaborating with cross functional scientific and technical teams.</li><li>Adaptability, energy, and willingness to work across time zones.</li><li>Innovative mindset with a track record of driving ideas to implementation.</li><li>Ability to work effectively in a cross-functional, team matrix environment</li><li>Comfortable interacting with a diverse team with wide-ranging skillsets.</li><li>Knowledge of MS Office tools, such as Word, Excel, PowerPoint, Visio and Outlook</li><li>Knowledge of regulatory (GLP and GCP) and pharmaceutical processes is recommended</li></ul>

Science Jobs in Oxnard, CA

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Science Jobs in Oxnard, CA

Principal Scientist - Immunogenicity Bioanalytical Sciences Amgen

Instructor in Biological Sciences, Initial focus: Microbiology (Part-Time Pool) Ventura County Community College District

Math and Science Teacher Fusion Academy

Scientist Senior Associate The Steely Group

Associate Scientist The Steely Group

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