Why Patients Need You

Our medical advancements would not reach patients without the expertise and dedication of our pharmaceutical manufacturing team. We depend on a team of committed and nimble professionals who grasp the significance and impact of their role in achieving our mission. Patients need diligent colleagues like you, who are proud of their work and constantly strive to improve outcomes. Your efforts will ensure that patients and healthcare providers have timely access to the medicines they require.

What You Will Achieve

By collaborating with vendor partners and scientific lines, you will ensure the timely delivery of drug product and maintain high standards of quality and compliance. Your efforts in compiling and authoring technical reports, along with providing accurate timing and cost estimates, will support our drug product sourcing and manufacturing initiatives.

• Handling Requests for Quotes (RFQ) and Requests for Information (RFI), vendor selection, and managing project schedules
• Facilitating GMP activities and logistics at vendor sites for PSSM programs
• Supporting Pfizer development compounds and comparator blinding through active participation in project teams

• Oversee the outsourcing programs for drug products to meet the needs of clinical teams.
• Assist in identifying suitable suppliers for Pfizer's drug product manufacturing campaigns by evaluating project requirements, vendor capabilities, available capacity, cost, and input from project teams during the quotation process.
• Ensure the seamless transfer of formulation design and process knowledge from Drug Product Design (DPD) to our vendor partners for successful manufacturing.
• Provide drug product manufacturing timelines and estimated delivery dates to Supply Chain Leads (SCLs) and Pharm Sci Team Leads (PSTLs) to support clinical and development planning. Offer updates and track drug supply manufacturing activities in response to demand requests and forecasts.
• Supervise the review and approval processes for GMP batch documentation.
• Manage the source-to-payment process for all outsourced manufacturing, including vendor selection, order placement, and invoice approvals.
• Coordinate the GMP manufacture of drug products at contract vendors.
• Work with GMP Analytics and Quality Operations teams to ensure timely product testing and disposition.

• Collaborate extensively with Global Clinical Supply (GCS) and Pharm Sci Small Molecule (PSSM) colleagues to define the clinical supply needs and to develop and implement project plans for outsourcing clinical supply deliverables across the PSSM clinical portfolio and all therapeutic areas.
• Engage with Procurement as necessary to address and resolve issues related to the procurement of drug product services from Contract Manufacturers and Pfizer Global Supply (PGS) sites.
• Provide real-time project status updates to internal clients and support teams, emphasizing the importance of strong written and verbal communication skills.
• Travel domestically and internationally, as required, to support supplier assessments, participate in critical face-to-face project meetings, and oversee manufacturing processes.

• Review and approve GMP documentation, including DMIDs, and coordinate the preparation and review of Master, Working, and Executed Batch Records with our vendor partners.
• Facilitate the prompt resolution of technical and quality/compliance issues at suppliers by partnering with scientific lines, Quality Assurance, and Regulatory CMC.
• Compile and author technical and investigational reports to identify, assess, and rectify quality issues, employing root cause analysis tools and methodologies.
• Monitor the delivery of product lots to clinical inventory or packaging sites, addressing any quality or logistics challenges that may occur during shipment.

• Provide accurate timing and cost estimates for proposed drug product sourcing and manufacturing initiatives.
• Assist teams in the development and enhancement of globalprocedures and business practices.
• Utilize internal IT systems to manage workflows as well as maintain and track metrics, including delivery performance.
• Implement the overall informatics strategy to drive automation and compliance into processes, including upgrades to planning and scheduling tools and the continued automation of workflows.

• Education- Bachelor's degree, preferred disciplines include Biology, Chemistry, Engineering, Pharmacy, Business or other relevant scientific or engineering area.
• 3+ years' experience in the pharmaceutical industry or equivalent required.
• Work experience must include a background in a regulated industry. Pharmaceutical and GMP experience is beneficial.
• Experience working with supply chain systems
• Experience in projects that require collaborative approaches, strong analytical skills & solid ability to understand business issues and processes
• Experience participating in matrix teams and managing complex deliverables within a team environment.
• Strong working knowledge of data management systems
• Excellent verbal and written communication skills in English, including a demonstrated ability to participate in teams with well-developed interpersonal skills.

• Master's degree.
• Experience in a planning environment of a production plant, preferably in the pharmaceutical industry
• Knowledge of aseptic manufacturing processes
• Additional certifications (e.g. Six Sigma, Project Management) desirable.

• Must be willing and able to travel both domestically and internationally (as required) to support key face to face supplier meetings and person in plant oversight, up to 30% at times.

• Last day to apply: November 29, 2024.
• Work Location Assignment: Hybrid.
• There's NO relocation support provided for this role.