Scientist/Senior Scientist, QC Technical Support
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 Scientist/Senior Scientist with expertise in late-stage analytical validation, stability and reference standard 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 drive the validation of QC GMP testing methods with contract testing laboratories (CTLs), as well as the method improvement or change for supporting late-stage development and biologics license application (BLA). The incumbent is expected to design, review and manage assigned laboratory studies at CTLs to meet project timelines. This position will report to the Director, ADQC.
· Manage the QC GMP method validation activities at CTLs according to analytical validation master plan and timelines. 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 the assigned projects for QC method improvement or change to product-specific methods. This may include, but is not limited to, HCP, ELISA, bioassays, and chromatographic impurity analysis.
· Prepare and review QC SOPs, protocols, and reports for the product stability program, reference standard qualification, product in-use compatibility studies, etc.
· Contribute to the investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results.
· Work in the lab for in-house analytical development or process analytics support of process development activities as needed.
· Drive the method transfers for future production capacity expansion.
· 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 of data in project team meetings.
· Degree (BS, MS, PhD) in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific field. Qualification for Sr. Scientist is minimum of 5 years of relevant industry experience for PhD, 12 years for MS and 14 years for BS level candidates. For Scientist, the minimum requirement is 0 years for PhD, 6 years for MS and 8 years for BS.
· Experience in late-stage ADQC (Phase III CMC development and PPQ) and BLA writing is highly desirable.
· Validation experience in QC analytical chemistry 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.
· Experience in QC stability program, reference standard, analytical control and cGMP (such as controlled document management, deviation root-cause analysis, CAPA and change control) is a plus.
· Flexible to work in the lab as needed.
· Proficient in statistical analysis related to ADQC.
· 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 projects simultaneously.
· Strong interpersonal skills and excellent oral and written communication skill a must.
The salary is competitive and commensurate with experience and qualifications.
Interested applicants please send resume to CMCcareers@allakos.com
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.