JOB DESCRIPTION:

• Oversee production activities at Contract Manufacturer (CMO) for manufacture of capsules.
• Collaborate with CMO and Pfizer External Supply Quality to ensure timely disposition of drug substance and drug product material. Provide a single voice/single point of contact for Pfizer – focal point to coordinate/prioritize requests.
• Coordinate information requests between Pfizer and CMO. Assist with flow of information and timely resolution of requests.
• Develop & monitor timelines associated with drug substance delivery, release, capsule manufacture and capsule/drug product release. Follow up on actions with CMO as required to ensure batches progress as per timelines. Includes active monitoring of production operations as well as review of critical documentation.
• Provide input into production schedules and general project-related tasks to manage batch prioritization in the face of unforeseen delays or quality incidents.
• Collaborate with CMO to coordinate document reviews & approvals.
• Collaborate with shipping and logistics organization (via Operation Teams) to coordinate movement of drug substance and drug product within network.
• Participate in Product project team to order to facilitate on time, Right First Time (RFT) manufacture.
• Observe batch manufacturing and project related activities & provide technical support for the manufacture of capsules.
• Timely communication of and facilitation of quality incident resolution.
• Lead cross-function joint team production meetings to review ongoing production activities and identify implementation issues for process improvement and/or corrective action projects.
• Responsible for clear communication between CMO and Pfizer (including to Ops Manager).
• Maintain a balanced relationship with CMO management in order to recognize need(s) for focused attention from Pfizer management.
• A good understanding of the appropriate Supply Agreements is required.

REQUIREMENT:

• Technical background required (quality background beneficial): minimum of BS degree plus 10-12+ years of experience in Chemical Engineering, or related science in Biotechnology or Pharmaceutical industry, or equivalent.

• Demonstrated Project Management required.

• Role will be primarily based at the CMO manufacturing facility in St Petersburg in Florida.

• Although typical hours would be M-F, 40 hours a week, there may be a requirement for work outside normal hours to support batch manufacturing.

• Experience in contract manufacturing and management of supply agreements a plus.

• Ability to quickly understand the operating principles of DP manufacturing (including soft gel manufacturing).

• Project management skills; ability to build plans, maintain timelines and develop mitigation strategies.

• Effective written and verbal communication skills; able to adequately communicate progress, issues, concerns and questions to CMO whilst maintaining good working relationship.

• Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure and in ambiguous situations

• Independent, self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment.

• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.