Sr. Research Associate, Potency Assays

Senior Research Associate will primarily focus on executing routine cell-based testing as per approved SOPs (QC-focused) for lot release/stability, comparability and formulation assessment of drug substances and drug products in accordance with cGMP standards, and contribute to develop, optimize and validate new cell-based assays, drafting SOPs and data analysis. This role will interface with Research, Discovery, Process Development, Manufacturing, Quality, and Facilities functional groups as well as external parties (CRO, CDMO) to support life cycle of bioassays for current and new candidates during early- and late-stage GMP production. This is a full-time and on-site position in the CMC department reporting to the Senior Manager of Cell-based Assays team.

RESPONSIBILITIES:

Benchwork/Documentation/Results analysis: 60% of the TIME

* Maintain cell lines, prepare, and qualify cell banks using aseptic techniques with emphasis on adherent mammalian cell culture systems.
* Develop, optimize, and execute bioassays including cell-based, nucleic acid-based, ELISA, and enzymatic assays with a strong scientific understanding of the analytical procedures and applicability of the emerging or existing assay platforms.
* Understand phase-appropriate GMP requirements for AAV-based gene therapy products.
* Performs routine testing of samples for characterization, Process Development support, and QC release/stability purposes under limited supervision.
* Provide feedback and/or suggest modifications to operational procedures.
* Assist with troubleshooting of analytical procedures and equipment problems; work with Facilities to assist with calibration, maintenance, and operation requirements of analytical equipment.
* Assist with the new facility expansion and equipment validation activities as needed.

Paperwork/Documentation: 40% of TIME

* Complete and submit experimental records following Good Documentation Practices, cGMP guidelines, and corporate policies to meet both operational and compliance requirements.
* Compiles Results from executed experiments and analyses and presents data to the manager, CBA team or in cross-functional meetings as needed.
* Contribute to experimental protocols, reports, internal documents including SOPs, lab records, deviations, and investigations as appropriate.
* Help with maintenance of lab inventories and database for designated project(s).
* Work closely with supervisors and cross-functional teams for setting up and following the testing schedule to meet timelines for products release, stability, and characterization purposes.
* Work closely with team to keep the reagents and lab supplies inventory stocked properly and within expiration.
* Follow all Quality and Safety procedures, including deviation and non-conformance reporting. Support deviation investigations and lab maintenance.
* Manages equipment PMs, change controls and equipment calibration documentation.
* Support implementation of new Laboratory Information Management System (LIMS)
* Other duties as assigned, nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

QUALIFICATIONS:

Education:

* MS degree in Biochemistry, Cell/Molecular Biology, or related area of life sciences with 3+ years of experience in cell-based bioassays or BS degree with 5+ years of experience in the pharmaceutical industry desired.

Required Skills:

* Proficiency with mammalian Cell/Tissue culturing and aseptic techniques.
* Hands-on experience in virus transduction and plasmid transfection of cells and troubleshooting.
* Hands-on experience and strong understanding of the technical concepts in immunoassays (Western Blotting, ELISA) and techniques such as ddPCR.
* Attention to detail, quality, and compliance with strict adherence to test procedures and protocols.
* Ability to learn new technologies and processes in a timely manner.
* Must be a team player with an analytical mindset, a detail-oriented critical thinker, and exhibit a readiness to meet project timelines and challenges in a dynamic fast-paced environment.
* Strong written and oral communication skills with demonstrated ability to present scientific ideas, information and data effectively via one-on-one discussions and team meetings.
* Basic math and familiarity with Excel, Word, and PowerPoint.
* Ability to work independently and work with others in designing and developing experiments, analyzing, and interpreting data.

Preferred Skills:

* Cell-based potency assay experience in the AD/QC environment.
* Hands-on experience with SDS-Page/Western Blot, protein-protein interactions, and flow cytometry.
* Experience in the development of new methods and sound scientific understanding of Quality by Design (QbD) and Design of Experiments (DoE) principles as well as data analysis and statistics.
* Experience with bioassay and/or statistical software such as SoftMax Pro, PLA, GraphPad, Minitab, JMP or Spotfire.
* Working knowledge of regulatory and industry guidelines in CMC analytical development.
* General understanding of compendial testing, ICH qualification/validation.

BASE SALARY COMPENSATION RANGE:

Bay Area-based candidates: $104,000/yr. - $125,000/yr.