29 days old

Associate, Oncology Operations

Pfizer
Pearl River, NY 10965
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**ROLE SUMMARY**

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 Standard Operating Procedures (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.



**ROLE 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 Current Good Manufacturing Practices (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 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 action/preventive action (CAPAs). Implement CAPA commitments.

+ Compliance - Perform other technical tasks as required to ensure cGMP 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.



**BASIC QUALIFICATIONS**



+ Bachelors Degree in Chemical Engineering, Chemistry, Biology, Microbiology, Biochemistry, or related scientific discipline required.

+ Bachelors Degree in other disciplines will be considered with hands-on work experience with drug substance intermediate, drug substance and drug product operation.



**PREFERRED QUALIFICATIONS**



+ Prior work experience with drug substance intermediate, drug substance and drug product operation preferred.

+ Lean Six Sigma education or certification preferred.

+ Technical writing skills/experience preferred.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**

This role is primarily first shift, Monday - Friday. Must be flexible to work outside of regularly scheduled work hours/weekends to support production schedule.



**Other Job Details:**



+ **Last Date to Apply for Job: 08 MAY 2020**

+ Eligible for Employee Referral Bonus

+ \#LI-PFE



**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.



Manufacturing
Posted: 2020-04-27 Expires: 2020-05-28
Sponsored by:
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Associate, Oncology Operations

Pfizer
Pearl River, NY 10965

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