The Senior Associate will contribute to building the Quality Control (QC) GMP infrastructure for the Abzena, Sanford facility. This role is responsible for testing raw materials, drug substance and drug product in-process, release and stability testing. The QC Specialist also oversees method qualifications and validations, out of specification/anomalous results investigations, and leads process improvements. The QC Specialist will train and mentor QC Associates.
- Assist in the release of raw materials, in-process materials, intermediates, APIs and finished products and perform (per test method or Compendia Requirements) quantitative analysis and data analysis of raw materials, in-process samples, GMP intermediates, final bulk drug substance, and stability samples
- Support QC laboratory analysts with quality systems management (training, change control, deviations, method transfer, etc.)
- Conduct OOS, OOT, non-conformance, risk assessment, gap analysis, investigation, and review of deviations, OOT, and implementation of CAPAs and root cause investigations and/or assist management of these investigations
- Author, review and revise Standard Operating Procedures (SOPs), technical documents, protocols, and reports
- Maintain laboratory notebooks according to good documentation practices
- Assist facility managers ensuring timely calibration of equipment
- Review qualification of equipment, performed by qualified vendors
- Complete qualification, transfer, validation, and routine of analytical methods for small molecule, protein, and antibody drug conjugate (ADC) compounds
- Document work in laboratory notebooks and logbooks according to organizational GDP policies
- Provide maintenance, cleaning, calibration, troubleshooting, and repair of analytical instruments and equipment
- Manage work carried out by third-party analytical and metrology service providers
- Support Quality testing in the Microbiology Department as needed
- Adhere to EHS and quality standards set by regulations
- Adhere to company’s quality standards, regulations, policies and procedures
- Operate to the highest ethical and moral standards
- Participate effectively as a team player in all aspects of Abzena’s business
- 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 work schedule effectively and efficiently
- Keep up to date with EHS, cGMP, scientific, and technical developments
- Evaluate lab practices for continuous improvement
- A BS degree in a relevant discipline (e.g., chemistry, biological sciences, bioengineering, etc.)
- Practical knowledge in all aspects of product development from investigational phase to commercial
- Experience in the establishment and operation of QC laboratories in a GMP regulated environment
- Strong technical writing skills
- A minimum of 5 years’ experience working in a GMP laboratory environment QC Management experience a plus
- Experience in 21 CFR Parts 210 and 211 and other applicable FDA/ICH guidance documents
- Experience in novel cytotoxic and antibody drug conjugate (ADC) compounds a plus
- Working knowledge of U/HPLC, GC, Karl Fisher, UV-Vis, FTIR, SDS-PAGE, ELISA, CE, and compendial assays
- Ability to multitask and work well under pressure
- The ability and knowledge to evaluate data trending and control chart interpretation
Travel between Abzena sites (Bristol PA, San Diego CA and Sanford NC) as needed.
- Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
- Frequently lift and or move objects up to 20 pounds.
- Stand/walk during entire length of shift.
- Use arms, hands and fingers to handle, feel or reach.
- Ability to wear the required personal protective equipment such as safety glasses, gloves, laboratory coat, dust/chemical inhalation protection, ear protection.
- Ability to climb stairs/approved step ladders, balance, stoop, kneel, crouch, or crawl.
- Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.