Technical Specialist, Clinical Manufacturing

Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our clinical 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 substance supporting the Pfizer Biotherapeutics portfolio. You will be part of a team responsible for the execution of upstream and downstream mammalian and microbial processes. You will coordinate and lead production operations on the manufacturing floor, and may participate in the qualification of process equipment, supporting development and clinical manufacturing activities. This role is a key communication and technical interface between the GMP manufacturing teams in the plant and our partner organizations.

As part of the Manufacturing Operations team, your prior work experience and ability to apply your breadth of knowledge will help you adapt to facility 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.
• Execute downstream mammalian and microbial purification processes in a GMP environment.
• Responsible for the equipment preparation, task scheduling, product processing, and maintaining facility cleanliness and compliance.
• 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, utilize continues improvement and root cause analysis tools.
• Maintain cross-functional communication with Tech Transfer team, Quality and Engineering.
• Perform troubleshooting of production equipment and operations.
• Understand scientific principles in order to problem solve and troubleshoot within limits of authority.
• Report any deviation or observation from established procedures.

QualificationsMust-Have

• High School Diploma or GED.
• 4+ years professional experience.
• 3+ years of experience in a biologics manufacturing or laboratory environment, with emphasis in either 1) mammalian or fermentation upstream processing or 2) downstream processing (including chromatography and filtration techniques).
• 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 work ethic.
• Excellent written and verbal communication skills, team oriented nature, and ability to thrive in a dynamic environment. Change agile.
• Strong computer skills in Microsoft Office required e.g. MS Word, MS Excel

Nice-to-Have

• Bachelor's Degree
• Familiarity with OSHA standards and experience with manufacturing safety.
• Experience owning and managing Deviations/CAPA and Quality Tracking System software.

  

PHYSICAL/MENTAL REQUIREMENTS

Ability to effectively gown into and operate in a clean room environment for extended periods of time. Gowning may include coveralls, head cover, face mask, boot covers and gloves.

Ability to lift 25+ lbs.

Ability to stand and walk for extended periods of time.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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

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