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> MANUFACTURING SENIOR PROJECT MANAGER

JOB DESCRIPTION

Biopharmaceutical Senior Project Manager with experience in managing the tech transfer of biopharmaceutical products from process development, drug substance manufacturing, drug product manufacturing, final packaging, and distribution. Ability to manage multiple projects and teams support Biopharmaceutical Facility clinical/ commercial manufacturing operations. This position will work closely with support functions including Process Development, Manufacturing, QC Labs, Supply Chain, and Quality to ensure successful ramp up to manufacturing operations. The candidate will support the tech transfer initiatives towards clinical/ commercial
Biopharmaceutical operations:


1. Utilize project management skills in support of the Tech Transfer and Manufacturing operations activities associated with the planning, manufacture, and delivery of products.
2. Collaborate with PD, MFG, Supply Chain, QC Labs, and Quality in the tech transfer of cGMP manufacturing operations.
3. Support the optimization of the client’s manufacturing Bill of Materials, Manufacturing Batch Records, Sampling Plans, Process Flows, Process Equipment, and Raw Materials.
4. Support operations (Technical, Quality, Supply Chain, & Manufacturing) activities associated with the planning, manufacture, and delivery of products.
5. Lead projects within the manufacturing team in support of clinical operations readiness.
6. Facilitate risk management and scenario planning programs for internal MFG operations.
7. Working knowledge of Quality Management Systems (QMS, Deviation, Change Management, CAPA, etc.) as manufacturing business owner.
8. Facilitate risk management and scenario planning programs for internal manufacturing operations.
9. Ensure the MFG process investigations are closed out in support of the timely release of the MFG process runs.
10. Support the design, development, and qualification of manufacturing execution systems, equipment, and systems.
11. Verify MFG projects within the manufacturing team in support of MFG operations readiness.
12. Lead training, mentoring, manufacturing readiness, and performance metrics programs for manufacturing.
13. Drive timely team decisions and escalation of critical information to senior management.
14. Utilize strong working knowledge of cGMP processes along with knowledge of regulatory compliance requirements to support plant inspection-readiness.
15. Lead in the authoring of Manufacturing Batch Records, interfacing with client representatives, and training of manufacturing staff on the floor.
16. Work closely with support functions including Process Development, Supply Chain, and Quality to ensure successful scale up of manufacturing process.
17. Other duties as assigned or required. 

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

  • Bachelor’s degree in a scientific discipline (i.e., Biology, Bioengineering, Chemical

  • Engineering, etc.) or 10 years of Biopharmaceutical (biotech, gene therapy, or cell therapy) experience. 

  • 6+ years of Biopharmaceutical manufacturing and distribution industry experience. 

  • Demonstrated experience supporting technology transfers, cGMP manufacturing operations and inspections experience.

  • Breadth of biopharmaceutical knowledge across manufacturing under cGMP, validation, Quality Systems, and regulatory requirements.

  • Demonstrated in-depth skills in contract negotiation, budgeting, and project management.

  • Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive decisions among individuals from a variety of cultures and disciplines.

  • Demonstrated track record of effective leadership and partnership.

  • Specific experience with ERP, MES, QMS, CMMS, and LIMS.

  • Previous leadership experience in manufacturing or operations environment.

  • Experience with computer and documentation systems.

  • Good decision making with strong judgment through collaboration and consideration of other’s point-of-view.

  • Ability to understand manufacturing process and equipment related engineering tools, such as process flow diagrams, and/ or engineering specifications/ requirements.

  • Expert problem-solver that leads with data, seeks subject matter expertise and is considerate of other’s point-of-view.

  • Self-motivated, flexible, and creative leader, able to prioritize, multi-task, work in a fast paced, and demanding environment.

HVAC CLEAN ROOM SME

ENGINEERING CVQ

QUALITY SME

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