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PF

Tech Ops 3 Clinical Mfg

Pfizer
United Statesfull_timeVerifiedPosted 19 Apr 2024
💰 $95,580/yr

About the role

Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

The clinical manufacturing technical specialist is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug products supporting the Pfizer Biotherapeutics portfolio. Technical Operations 3 of Biotherapeutics Drug Product Manufacturing is a GMP Drug Product manufacturing position responsible for the execution of batch records following site approved standard operating procedures (SOP) inside the Andover Liquid Dose Manufacturing Facility (AN-LDM).  This position will maintain and prepare equipment, revise SOPs, Train personnel, formulate drug products, aseptically fill drug products.

As part of the Technical Operations team, your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.

It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Manage own time, professional development, and be accountable for own results.
  • Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.
  • Adhere to Good Manufacturing Practices and standard operating procedures, and material sampling instructions.
  • Responsible for the equipment preparation, formulation and aseptic filling of biologic drug products.
  • Complete recurring assignments independently and select the most appropriate method or approach to do so within prescribed limits of authority.
  • Identify opportunities for continuous improvements and enable implementation.
  • Perform troubleshooting of production support equipment and operations.
  • Understand scientific principles in order to problem solve and troubleshoot test results.
  • Report any deviation or observation that might lead to adverse impact to product quality.
  • Complete work instructions and maintains clean room environment to comply with regulatory requirements.

Qualifications

Must-Have

  • High School Diploma or GED
  • 5+ years of experience
  • Certification in assigned area, if applicable
  • Drug product filling/ Final fill experience
  • Demonstrated experience in a biotechnology manufacturing or laboratory environment
  • Experience in cGMP (Current Good Manufacturing Practices) compliance as related to manufacture of biologics
  • Ability to think critically and demonstrate troubleshooting and problem-solving skills
  • Strong workload planning skills, organization, and attention to detail, and follow through
  • Excellent written and verbal communication skills
  • Strong computer skills in Microsoft Office required e.g. MS Word, MS Excel

Nice-to-Have

  • Bachelor's Degree
  • Liposome manufacturing experience
  

PHYSICAL/MENTAL REQUIREMENTS

Role tasks will include frequent bending, lifting (up to 40 pounds) and twisting motions.

Ability to stand for several consecutive hours

Absence of any medical restrictions which could restrict completion of all required duties

Must be able to meet gowning requirements


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Shift is 7am to 5:30pm (4 by 10 hour work day rotating week to week, Monday through Friday schedule)

Overtime may be required

Aseptic Gowning required


Work Location Assignment: On Premise


The salary for this position ranges from $28.68 to $47.79 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candida

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Company

Pfizer

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