Company Description
Abzena is a leading end-to-end bioconjugate, ADC, and complex biologics CDMO + CRO. From discovery through commercial launch, Abzena supports customers with integrated programs or individual services designed to de-risk and streamline the development of new treatments. Abzena tailors its strategy and customer experience for each project, developing innovative solutions that move medicines forward faster. The company has research, development, and cGMP facilities across San Diego, CA, Bristol, PA, and Cambridge, UK.
Role Description
This is a full-time on-site role for a Sr Manufacturing Specialist located in San Diego, CA. The Senior Manufacturing Specialist is a technical subject matter expert supporting late-stage clinical and commercial biologics production. This role is responsible for leading and supporting manufacturing investigations, identifying true root causes, and developing effective corrective and preventative actions (CAPAs). The Senior Manufacturing Specialist will also play a key role in driving process improvement initiatives to ensure compliance, efficiency, and operational excellence.
The ideal candidate will bring strong cGMP manufacturing experience along with exceptional written and verbal communication skills to collaborate effectively across Manufacturing, Quality, Development, and other functions.
Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related discipline; advanced degree preferred.
Minimum 3 years of hands-on experience in a cGMP manufacturing environment, with strong preference for late-stage clinical or commercial biologics.
Demonstrated expertise in root cause analysis methodologies (e.g., 5-Whys, Fishbone, FMEA).
Proven ability to develop and implement effective CAPAs and sustainable process improvements.
Strong technical writing skills and excellent verbal communication skills.
Ability to clearly present technical findings to diverse audiences, including cross-functional teams and regulatory inspectors.
Strong organizational skills and ability to manage multiple priorities in a fast-paced environment.
Physical Requirements
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 30 pounds.
Stand/walk during entire length of shift.
Use arms, hands and fingers to handle, feel or reach.
Ability to climb, balance, stoop, kneel, crouch, or crawl.
Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
