Manager/Sr. Manager QC Analytical Transfer

Location
Redwood City, CA, United States
Posted
Oct 26, 2020
Ref
1533856911
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
The successful candidate will set up and manage the QC analytical program with a new DS/DP contract manufacturing organization (CMO) site as part of a manufacturing capacity expansion program for a late-stage development product (monoclonal antibody).

The incumbent will be the point of contact person for analytical activities with the new CMO site, lead the transfer and validation of GMP testing methods to the new testing laboratories, manage QC document review including product specification, sampling plan and stability protocols to support GMP and PPQ batch production at the CMO site. Supported by the current analytical team, the incumbent is expected to drive the assigned QC activities to meet project timelines and work closely with process development and the manufacturing team, QA, and Regulatory Affairs. This position will report to the Director of ADQC.

Primary Responsibilities:
  • Drive the method transfer and validation with the new testing laboratories according to analytical transfer/validation master plan and timelines. In collaboration with analytical SMEs, the incumbent will provide technical review and identify potential gaps in transfer or validation protocols/reports to ensure the 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 and Reference Standard) at the new manufacturing scale, 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.
  • Review the process development and validation documents and provide analytical support as needed.
  • Support the preparation and review of CMC sections related to analytical procedures, method validation, specifications, batch analysis, reference standard and stability in regulatory submissions, such as supplemental BLA to obtain approval on the new manufacturing and testing site.
  • Critical scientific/technical data analysis and presentation in project team meetings.


Qualifications:
  • 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 for Manager position and 7 years for PhD, 15 years for MS and 17 years for BS for Sr. Manager.
  • Experience in late-stage product development and commercial methods transfer is highly desirable.
  • Analytical validation or transfer expertise 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 external manufacturing and contract testing 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 compensation is competitive and commensurate with experience and qualifications.

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.