The Analytical Development Scientist ADQC provides strong scientific judgment as well as hands-on laboratory expertise within the ADQC laboratory. This role focuses on driving day-to-day lab performance, ensuring consistent cGMP and regulatory compliance and data integrity standards. The role is responsible for executing analytical development activities supporting biologics programs from early phase to pivotal phase, regulatory submission, and commercialization. The incumbent will lead method development, optimization, qualification, validation, method transfer to internal and external laboratories, method lifecycle management, and ensure analytical readiness to support CMC milestones and regulatory submissions.
The ability to collaborate effectively with cross-functional teams and external partners in a highly regulated, fast-paced environment is crucial to this position.
Please note that some relocation assistance is available for this role.Duties and Responsibilities (Include but are not limited to):- Lead and perform hands-on analytical work including method development, qualification, validation, transfer to internal and external QC labs, lifecycle management, and author associated documentation (method development reports, technical reports, qualification / validation reports, method SOP etc.)
- Ensure analytical readiness for late-stage development, PPQ, and commercial launch of SAB-142 polyclonal antibody program.
- Lead and perform hands-on method troubleshooting, method optimization, method bridging, method performance monitoring, investigations (deviations, system suitability failure, OOT, OOS), CAPA, change control, continuous method improvement initiatives, and author associated documentation.
- Contribute to qualification and stability monitoring of reference standard, assay control, and critical reagents, qualification and testing of extended characterization assays, and forced degradation/stress sample study.
- Ensure analytical activities performed internally and at external partners are scientifically rigorous, comply with cGMP, ICH, USP, global regulations, and QbD principles, and align with industry's best practices and company quality standards.
- Contribute to specification setting, and regulatory submissions.
- Manage general laboratory operations, equipment qualification & maintenance, support the scaling of analytical capabilities, establishment of analytical non-GMP development area, and implementing workflows and LIMS.
- Partner closely with Quality Control and Quality Assurance to establish, maintain, and oversee analytical quality, GMP compliance infrastructure, and inspection readiness for internal and external analytical documents and data.
- Other duties/responsibilities as assigned.
Supervisory Responsibilities:This position does not supervise employees at this time. May supervise junior staff as the group expands.
Will have indirect supervisory level responsibilities with external partner/CDMO partnerships, and relationships.
Education/Experience/Skills:- Bachelor's degree with 7+ years of progressively responsible and relevant experience in life sciences, Biophysics, Biochemistry or a related discipline in a biotech/pharma environment. Master's degree highly desirable.
- Deep hands-on expertise in A280, HPLC, CE-SDS, cIEF, and LC-MS for biologics. Experience in ELISA, and cell-based potency methods is a plus.
- Strong understanding of method validation, method transfer, and applicable guidelines (ICH, FDA guidance documents, USP/EP chapters etc.) with deep expertise in cGMP requirements.
- Experience in reference standard program, critical reagent program, and forced degradation study
- Utilizes established mathematical and scientific techniques including simple statistical analysis to compile and analyze data. Trend analysis /control charting is a plus.
- Strong written and verbal communication and technical writing skills and the ability to effectively present information in one-on-one, small groups, and departmental/cross functional meetings.
- Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint and Outlook).
Working Environment and Travel:Duties will be performed in normal office, laboratory and BSL2 laboratory environments.
Travel is not typical for this position.
Physical Requirements: Ability to regularly move up to 10 pounds. Specific vision abilities required by this individual include close vision, peripheral vision, and the ability to adjust focus. The employee will view a computer monitor for long periods of time.
This job description will be reviewed periodically as duties and responsibilities change with business necessity. Primary and additional duties and responsibilities are subject to modification.
