Associate Oncology Operations Drug Product
Job Description
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.
What You Will Achieve
The position performs 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.
How You Will Achieve It
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 work place 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.
Qualifications
Applicant must have a High School Diploma (or Equivalent) and 6 years of relevant experience OR an associates degree with 4 years of experience OR a bachelors degree with 0+ years of experience.
On the job and “hands-on” training will be provided for drug product operations.
Lean Six Sigma education or certification preferred but not required.
Physical/Mental Requirements
Lifting of 20 lbs, standing for long periods, intermittent night and weekend work.
Ability to perform mathematical calculations and complex data analysis.
Ability to apply general engineering techniques/principals.
Ability to operate automated process control systems.
Ability to analyze operational process problems and implement appropriate corrective and preventative actions.
Effectively interact with team members within and across functions. Can articulate the issues and solutions to both team and to management. Ability to organize and present data to related team meetings or sr. management and poster presentations at external meetings, communicating effectively in both written and oral forms.
Ability to make timely and sound decisions.
Assimilates new knowledge skills, and job-related information that may vary in complexity, and applies them to work assignments in a timely manner.
Generate different creative or novel solutions to business processes. Evaluate the latest technology advances and apply to appropriate business problems.
Non-Standard Work Schedule, Travel, or Environment Requirements
Potential for non-standard work hours (2nd or 3rd shift) during manufacturing activities.
Intermittent night and weekend work.
Operator gowning requirements, including full facemask or respirator.
Adherence to departmental procedures and safety policies.
Work Location Assignment: On Premise.
Other Job Details
Last day to apply: November 29, 2023.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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