Associate, Drug Product Oncology Operations
About The Position
Use Your Power for Purpose The position performs Drug Product manufacturing of commercial and clinical conjugate related products. Primary duties include performing all required complex manufacturing activities including production, investigation, equipment validation, writing SOPs, in compliance with company policy and regulations. Assist developing detailed plans and prioritize the routine tasks within the plan to achieve goals of incumbent’s projects. Actively develop technical and operational leadership on all aspects of the manufacturing operations and contribute to the success of the department. What You Will Achieve Multi-task all activities associated with manufacturing of commercial and clinical antibody drug conjugates including but not limited to operation, cleaning, investigation, change control, conducting training, etc. Heavy “hands-on” operations and irregular work schedules occasionally required. Function as a member of self-directed high-performance team. Perform manufacturing of commercial and clinical batches in compliance with cGMP, Safety, and Environmental regulations. Meet the production demand. Ensure all Investigations and commitments are performed in a timely manner. Ensure all production equipment and systems are in compliance with cGMP. Create or modify Standard Operating procedures (SOPs) for commitment implementation or as related to new projects, facility and equipment changes. Evaluate and approve Preventive Maintenance Orders (PMOs). Initiate change controls related to new projects, facility and equipment changes, BR and PMO revision, etc. Assist in problem solving efforts for manufacturing processes. Troubleshoot process issues, diagnose technical problems and identify short- and long-term solutions. Work closely with cross-functional groups to resolve system problems to minimize contamination and cost. Conduct manufacturing deviation investigations and write investigation reports (MIRs). Identify root causes and corrective/preventive actions (CAPAs). Implement CAPAs commitments. Compliance - Perform other technical tasks as required to ensure GMP and safety compliance. Promote cGMP compliance within the workplace by following site cGMP procedures. Incorporate cGMP and regulatory compliance into all assigned projects scope and design. Provide project team support as required by team leads.
Requirements
- Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience
- Hands-on experience with aseptic processes
- On the job and “hands-on” training will be provided for drug substance intermediate, drug substance and drug product operation.
- Understanding of Aseptic Techniques
- Capable of Lifting up to 50Lbs.
- Non-Standard work schedule, travel or environment requirements
- Occasionally will participate in weekend and overnight work during the manufacturing
Nice To Haves
- Pharma industry experience
- Lean Six Sigma education or certification preferred but not required
Responsibilities
- Multi-task all activities associated with manufacturing of commercial and clinical antibody drug conjugates including but not limited to operation, cleaning, investigation, change control, conducting training, etc.
- Heavy “hands-on” operations and irregular work schedules occasionally required.
- Function as a member of self-directed high-performance team.
- Perform manufacturing of commercial and clinical batches in compliance with cGMP, Safety, and Environmental regulations.
- Meet the production demand.
- Ensure all Investigations and commitments are performed in a timely manner.
- Ensure all production equipment and systems are in compliance with cGMP.
- Create or modify Standard Operating procedures (SOPs) for commitment implementation or as related to new projects, facility and equipment changes.
- Evaluate and approve Preventive Maintenance Orders (PMOs).
- Initiate change controls related to new projects, facility and equipment changes, BR and PMO revision, etc.
- Assist in problem solving efforts for manufacturing processes.
- Troubleshoot process issues, diagnose technical problems and identify short- and long-term solutions.
- Work closely with cross-functional groups to resolve system problems to minimize contamination and cost.
- Conduct manufacturing deviation investigations and write investigation reports (MIRs).
- Identify root causes and corrective/preventive actions (CAPAs).
- Implement CAPAs commitments.
- Compliance - Perform other technical tasks as required to ensure GMP and safety compliance.
- Promote cGMP compliance within the workplace by following site cGMP procedures.
- Incorporate cGMP and regulatory compliance into all assigned projects scope and design.
- Provide project team support as required by team leads.
Benefits
- a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
- paid vacation, holiday and personal days
- paid caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
