Manager QC Technical Support # 1016
Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.
The company is seeking to recruit a Manager QC Technical Support with expertise in QC method validation, transfer, routine testing, stability and specification to join our expanding team in the group of Analytical Development and Quality Control (ADQC). The scope of the position and requirements are described below.
The successful candidate will support the validation and transfer of GMP testing methods with contract testing laboratories (CTLs), manage QC document review including product specification to support GMP batch production, and be responsible for the product stability program (Drug Substance, Drug Product, Placebo and Reference Standard) for late-stage product development and biologics license application (BLA). The incumbent is expected to drive the assigned QC activities to meet project timelines and work closely with QA and Regulatory Affairs. This position will report to Director ADQC.
- Provide project management support for method validation and transfer with CTLs according to analytical validation/transfer master plan and timelines. In collaboration with analytical SMEs, the incumbent will provide technical review and identify potential gaps in validation protocols/reports to ensure the validation studies are designed and executed in compliance with current regulatory guidance and industrial practices.
- Manage QC document review to support GMP batch production. Support the review of QC release data packages with analytical SMEs, draft the release CoA and obtain QA approval.
- Responsible for the GMP product stability program (Drug Substance, Drug Product, Placebo and Reference Standard), provide timely review of stability data to identify potential trending issues, review the stability protocols and reports with analytical SMEs.
- Manage the GMP release specification documents, review the vendor provided specification documents and support the relevant change control of specification.
- Contribute to the investigation and disposition of atypical, out-of-specification (OOS) and out-of-trend (OOT) testing results.
- May work in the lab for in-house analytical development or provide process analytics support as needed.
- Support the preparation and review of CMC sections related to analytical procedures, method validation, specifications, reference standard and stability in IND, IMPD, BLA, MAA and other regulatory submissions.
- Critical scientific/technical data analysis and presentation in project team meetings.
Qualifications and Expertise:
- Degree (BS, MS, PhD) in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific field, with relevant industry experience of 2 years for PhD, 9 years for MS and 11 years for BS at minimum.
- Experience in late-stage product development (Phase III CMC development or pre-launch) and BLA writing is highly desirable.
- Analytical validation or transfer experience in a wide range of QC methods such as cell-based assays, ELISA, residual HCP, qPCR, ADCC, HPLC, CE, color, clarity, visible particles, A280, chemical impurities, excipients test, etc. Experience in QC microbiology methods such as sterility, bioburden, endotoxin and environmental monitoring is a plus.
- Technical understanding in analytical standard, control, critical reagents, stability program and cGMP system (such as controlled document management, QC laboratory events, deviation root-cause analysis, CAPA and change control) is essential.
- Highly flexible to changing priorities and task assignments based on business need.
- Proficient in statistical analysis software (e.g., JMP) related to QC data analysis.
- Project management experience is a plus. Working experience with CDMOs/CTLs is a plus.
- Detail-oriented and capable of identifying and solving complex scientific problems.
- Ability to work independently in a fast-paced environment and drive multiple priorities simultaneously.
- Strong interpersonal and communication skill is a must.
The salary is competitive and commensurate with experience and qualifications. Interested applicants please send resume to CMCcareers@allakos.com and reference Job#1016
Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.