Scientist I, ADQC
Scientist I, ADQCAllakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients’ lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
Position Summary:As a member of the Allakos team you will have the opportunity to support our contract testing laboratories (CTLs) and contract manufacturing organizations (CMOs) and oversee the routine testing and 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 cross-functional teams including QA, Regulatory Affairs, Manufacturing, Project Management, and Supply Chain. This position will report to Sr Scientist, ADQC.
- Support the GMP product stability program (Drug Substance, Drug Product, Placebo and Reference Standard). Review the stability protocols and reports, provide timely review of stability data from CMOs, compile the data and perform trending analysis to identify potential issues, and provide timely update to the team. .
- Provide QC support for DS and DP manufacturing and testing. Review the QC release testing records, draft the release CoA and obtain QA approval.
- Provide QC support for temperature excursions related to GMP bulk DS/DP shipment, storage and clinical product distribution to clinical sites.
- Manage special testing (both GMP and non GMP testing) at contract testing laboratories. Review study quote, statement of work, protocols and reports. Coordinate sample submission as needed. Draft the release CoA/CoT and obtain QA approval.
- Manage the analytical material inventory and sample shipment with project managers.
- Support the investigation and disposition of atypical, out-of-specification (OOS) and out-of-trend (OOT) testing results. Support the QC change control documentation.
- Some lab based activities may be required as part of managing inventory and shipping roles and supporting investigations as needed.
- Critical scientific/technical data analysis and presentation in project team meetings. Author technical documents as needed.
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, 6 years for MS and 8 years for BS.
- Technical understanding and/or experience in analytical standards, controls, critical reagents, stability programs and cGMP systems (such as controlled document management, QC laboratory events, deviation root-cause analysis, CAPA and change control) is essential.
- Proven working experience in a QC testing lab is highly desirable.
- Proficient in statistical analysis software (e.g., JMP) related to QC data analysis is highly desirable.
- Experience in analytical method validation and transfer is a plus. Experience in antibody extended characterization is a plus.
- Strong interpersonal and communication skills are a must.
- Detail-oriented and capable of identifying and solving complex scientific problems.
- Ability to work independently in a fast-paced environment and on multiple priorities simultaneously.
- Highly flexible to changing priorities and task assignments based on business need.