Manufacturing Operations Manager (Pharma Manufacturing, CMC, cGMP)
I am urgently seeking a CMO Manager (Manufacturing, Supply Chain, Pharmaceutical Development) interested in a 12 month contract opportunity with a Global Pharmaceutical company in Boston/Cambridge, MA area!
Ideal candidate must have:
- Pharma Manufacturing experience is a must.
- At least BS in Chem, Biology or Science related field.
- At least 7years experience with Manufacturing, Supply Chain, or Pharma Development.
- Working knowledge of manufacturing operations, biologics drug substance manufacturing, drug product manufacturing (oral solid dose/parenterals) pharmaceutical packaging, CMC regulations, cGMP, and sterility assurance techniques.
- Willingness to travel for work.
The CMO Manager is responsible for managing the Global Contract Manufacturing relationships for commercial drug product-lyophilized parenterals and capsules. The focus for this position is for the management of oncology therapies distributed globally. The CMO Manager will work together with Quality Assurance, Quality Control, Regulatory Affairs, and Technical Operations to ensure product quality and supply demand is consistently met for Takeda’s Commercial Products.
• Day to day management of routine production of Drug Product and Finish goods packaging sites.
• Primary CMO contact for operational and business relationship activities.
• Leads a core team comprised of QA, QC, Regulatory Affairs, Technical Operations, and Logistics, and Supply Operations Systems personnel to effectively manage CMOs.
• Responsible for initiation and timely resolution of deviations and change controls associated with routine manufacture of drug product and finished goods. Triages out to Technical Operations for troubleshooting, and management of in depth process investigations, as appropriate.
• Authors, reviews, and/or approves pertinent SOP’s and manufacturing process instructions.
• Authors or reviews pertinent CMC sections for regulatory submissions.
• Participates in CMC teams for key therapeutics distributed globally.
• Administering purchase orders related to project execution as needed.
• Identify continuous improvement and process improvement opportunities.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
The candidate should preferably have a BS in chemistry, biology, or closely related disciplines and 7+ yrs of experience working in manufacturing, supply chain, or pharmaceutical development. The candidate should have a good working knowledge of manufacturing operations, biologics drug substance manufacturing, drug product manufacturing (oral solid dose and/or parenterals,) pharmaceutical packaging, CMC regulations, cGMP, and sterility assurance techniques. The candidate should have demonstrated written and oral communication skills and ability to work in a cross functional team environment. The candidate should also be self-motivated, able to thrive in a fast paced environment with minimal direction and be able to multitask, to work on a number of deadline driven projects simultaneously with a sense of urgency. Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
• Office work
• Computer use
• Airline travel
• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
• Position requires up to 25% domestic and international travel.
This job has been posted by Sarah Fletcher, Clinical Recruiter.