Manufacturing Specialist

Role Summary

Manufacturing Specialist responsible for hands-on technical leadership in process development, technology transfer, and process operations within a phase-appropriate cGMP environment. Tasks include executing technology transfer from lab to manufacturing, designing and developing downstream processes, and authoring or reviewing technical documentation. Mentors junior team members and participates in cross-functional initiatives while adhering to budgets and compliance requirements.

Responsibilities

• Demonstrates hands-on technical leadership of process development, technology transfer, and process operations within a phase appropriate cGMP environment.
• Responsible for executing technology/process transfer from Lab to manufacturing production floor and provide technical input and support during manufacturing of drug products.
• Lead the design and development of downstream processes, including design of experiments, process optimization, data interpretation and analysis.
• Author or review technical documentation (development reports, process description, process flow protocols, batch records, etc).
• Mentor junior team members on process operations and development strategies, experimental design and execution as well as process transfer.
• Participate in cross functional initiatives.
• Adhere to department budget and all training, compliance, and safety requirements.

Qualifications

• Required: M.S. with 2+ years or BS with 4+ years’ experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).
• Preferred: Strong understanding of biologics/sterile injectable product manufacturing processes (bulk freeze/thaw, mixing/pooling, filtration, filling and/or lyophilization).
• Preferred: Experience supporting drug product manufacturing operations, technology transfer, and/or development; prior experience with commercial manufacturing and/or process validation is highly desirable.
• Preferred: Hands-on experience with process operations including centrifugation, normal flow filtration, high throughput purification screening and development, chromatography operations, tangential flow filtration, formulation development and technical transfer.
• Preferred: Broad understanding of downstream development and scale up including process transfers for new product introduction into the production lines.
• Preferred: Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities.
• Preferred: Working knowledge of cGMPs and regulatory requirements of biopharmaceutical manufacturing.
• Preferred: Experience in cleaning process design, verification, and cross contamination strategies.
• Preferred: Motivated self-starter with excellent interpersonal and organizational skills; strong verbal communication, presentation, and scientific writing abilities.

Skills

• Process development and technology transfer
• Downstream processing
• Documentation and technical writing
• Experiment design and data interpretation
• Cross-functional collaboration
• Compliance with cGMP and regulatory requirements

Education

• M.S. in a relevant scientific discipline or B.S. with extensive relevant experience as specified above.