Sr. Scientist/Scientist, Biochemistry
Sr. Scientist/Scientist, Biochemistry
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 Sr. Scientist/Scientist, Biochemistry 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 be responsible for the development and improvement of bioassays and impurity immuno-analysis, which include, but are not limited to cell-based potency and ELISA methods. The incumbent is expected to design, execute and manage laboratory studies both in-house and at CDMOs/CTLs for supporting clinical trial and product license application. This position will report to the Director, ADQC.
· Develop and optimize cell-based potency, ELISA methods (functional and impurities), residual DNA qPCR and other biochemical analysis to support the biological characterization of antibody products.
· Serve as technical resource for analytical method issues, especially data interpretation, method troubleshooting and improvements.
· Design and execute studies in-house to increase the understanding of candidate molecules and support the process development activities with Upstream, Downstream and Drug Product development functions.
· Drive the method transfers and validation with CDMOs/CTLs.
· Prepare and review QC SOPs, protocols, and reports related to product release, stability study, method validation, etc.
· Support Research groups on assay design and transition of new molecules to CMC development.
· Identify new analytical technologies and opportunities for improvement.
· Contribute to the investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results.
· Support the preparation and review of CMC sections related to analytical procedures, method validation, specifications, reference standard and stability in INDs, IMPDs, MAAs, BLAs, 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.
· Preferred qualification for Sr. Scientist is minimum 5 years of relevant industry experience for PhD, 10 years for MS and 12 years for BS level candidates. For Scientist, the preference is 0 years for PhD, 5 years for MS and 7 years for BS. Candidates with equivalent combination of academic achievements and industry experience will be considered.
· Expert experience in analytical methods such as cell-based assays, ELISA, residual HCP, 2-D gel analysis, reporter gene analysis (e.g. luciferase), qPCR, Biacore/Octet, ADCC and CDC is required.
· Experience in QC microbiology methods such as sterility, bioburden, endotoxin and environmental monitoring is a plus.
· Experience in cGMP (such as document management, deviation root-cause analysis, CAPA and change control) and QC practices including reference standard, control chart, stability, IOQ and validation is a plus. Working experience with CDMOs/CTLs is a plus.
· Strong understanding in statistical analysis related to method development 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.
· Physical ability to lift up to 30lbs and work at the lab bench for extended periods of time.
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.