Sr Manufacturing Specialist chez Abzena

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.

Responsibilities

Serve as SME for manufacturing operations, equipment, and processes.

Lead investigations into deviations, process failures, and equipment issues, ensuring accurate root cause identification and timely resolution.

Author clear, concise, and technically sound investigation reports and CAPA documentation.

Develop and implement effective CAPAs that address underlying issues and ensure sustainability.

Drive continuous improvement initiatives to optimize manufacturing processes, increase efficiency, and strengthen compliance.

Partner with cross-functional teams (Quality, Development, Engineering, Supply Chain) to ensure alignment on solutions and process changes.

Provide technical expertise and support during regulatory inspections, audits, and internal reviews.

Analyze production data and KPIs to identify trends, risks, and opportunities for improvement.

Mentor and support operations staff in applying root cause analysis and problem-solving tools.

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. 

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