Senior GMP Analytical Scientist
Location: Bristol, PA
Area: Analytical Method Development
The principle responsibility of the GMP Analytical Scientist/Senior GMP Analytical Scientist is analytical support for GMP manufacturing and process development. The GMP Analytical Scientist/Senior GMP Analytical Scientist may also provide analytical services for discovery and R&D projects as needed. This is a hands-on laboratory position with additional technical, supervisory, and management responsibilities dependent on experience and expertise.
Typical Duties Include:
- Development, optimization, qualification, transfer, validation, and routine execution of analytical methods for small molecule, protein, and antibody drug conjugate (ADC) compounds.
- Sample types may include raw materials, in-process materials, intermediates, APIs, finished products, related substances, stability samples, cleaning verifications, etc.
- Analytical techniques may include UV-visible spectroscopy, RP-LC, SEC, HIC, CEX, SDS-PAGE HPLC/UPLC, LC-MS, q-TOF, capillary electrophoresis, ELISA, peptide mapping, SEC-MALS, DSC, MFI, DLS, cIEF, Karl Fischer, FTIR, pH, conductivity, osmolality, appearance, binding ELISA, etc.
- Preparation and review of standard operating procedures (SOPs), analytical test methods, standard work instructions, technical documents, protocols, reports, etc.
- Conduct OOS, non-conformance, risk assessment, gap analysis, and root cause investigations and/or assist management with these investigations
- Write deviations, change controls, and CAPAs, and/or assist management with these documents
- Documentation of work in laboratory notebooks and logbooks according to organizational GDP policies
- Management of work carried out by third-party analytical and metrology service providers
- Adherence to organizational EHS policies and maintenance of work areas in a safe, clean, and orderly fashion
- Peer review of analytical data
- Train and mentor junior scientists
- Comply with all organizational policies and procedures
- Operate to the highest ethical and moral standards
- Adhere to EHS and quality standards set by regulations and Abzena policies, procedures, and mission
- Work with other teams to determine analytical methods and instruments needed to support GMP manufacturing
- Communicate effectively with supervisors, support staff, colleagues, clients, vendors, etc.
- Attend, contribute to, and lead relevant meetings
- Prioritize, plan, and manage their own work schedule effectively and efficiently
- Keep up to date with EHS, cGMP, scientific, and technical developments
- Evaluation of lab practices for continuous improvement.
- Degree in analytical chemistry, chemistry, biology, biochemistry, or related discipline
- Relevant experience in the biopharmaceutical industry: 3-6 years with B.S., 2-5 years with MS, or 1-4 years with PhD degree
- Excellent verbal and written communication skills
- Ability to collaborate and work well in teams and independently, with minimal supervision
- Extensive knowledge of USP, ICH, FDA, 21 CFR, and other guidance documents
- Experience in biologics or small molecule analytical development
- Experience in a QC or GMP manufacturing environment
- Experience in HPLC troubleshooting and maintenance
- Experience in characterization of proteins, intact and on the peptide level, including sample preparation and or experience with small molecule analytics
- Good understanding of protein conjugation and purification techniques would be an advantage.