Senior GMP Analytical Scientist - Abzena

Senior GMP Analytical Scientist

Location: Bristol, PA
Area: Analytical Chemistry

Overall Responsibility

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

 

General Responsibilities:

  • 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.

 

Qualifications/Skills Required:

  • 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.

 

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