Description:

The Senior Manager, Manufacturing will have functional responsibility for managing the drug substance manufacturing plans at Contract Manufacturing facilities and reports to the Sr. Director, Contract Manufacturing.  This responsibility includes oversight of the manufacturing of products at the contract manufacturing site, providing technical support, facilitating and tracking progress of manufacturing schedules, project milestones, and coordination of local activities. 

Job Responsibilities:

• Day to day management of Contract manufacturing Organization (CMO’s).
• Work closely with Inspiration’s site Quality representatives supporting the manufacture of clinical and commercial materials.  Works with the Quality to resolve CAPA’s, deviations and change controls.
• Works with the CMO functions, provides manufacturing guidance and direction to CMO manufacturing unit and workforce consistent with established contracts, quality agreements, and regulatory filings.
• Ensures that the appropriate systems are in place to manufacture commercial products and monitors the same. 
• Works with the CMO, external and internal resources to adequately perform tech transfer and validation of processes.
• Ensures continuous process control and improvement of the manufacturing processes.
• Contributes to plans and strategies for developing the production schedules, maintaining inventories, and managing the cost of goods, yield improvement, cost reduction, next generation processes and budgets.
• Serve as project leader or team member of company project teams or sub-teams, as assigned.
• Evaluates and approves various documents related to the development and manufacture of clinical and commercial products including manufacturing instructions, executed records, investigations, procedures, validation protocols and reports, characterization protocols and reports, and other documents related to the development, analysis, and manufacture of products.
• Supports the preparation, coordination, and management of regulatory agency filings and inspections.
• Effectively communicates project expectations to team members and stake holders in a timely and clear fashion.

Experience and Background:

• Excellent experience with cGMPs and all applicable regulations and guidance
• B.S./B.A. and 10-15 years in the biopharmaceutical/pharmaceutical environment
• Education in the scientific, pharmaceutical science, or engineering discipline
• Minimum of 5 years experience managing commercial biopharmaceutical (drug substance) manufacturing. 
• Experience working with contract manufacturers or as a member of a contract manufacturing organization.
• Process validation experience.
• Strong interpersonal, leadership, planning, organizing and communication skills are required
• Self-motivated, highly organized and personable individual.  Capable of driving completion of activities by CMOs through the use of influence skills
• Drug substance development experience and clinical manufacturing experience is a plus.

To apply for a position at Inspiration, please email your cover letter and CV to careers@inspirationbio.com.  Please note within the subject of the email the position you are interested in.