ROLE SUMMARY

The colleague will be part of a team performing scientific, operational and process engineering tasks as they relate to technology transfer, scale-up operations, capital projects and routine manufacturing support.  You should have the cross-functional scientific ability/skills/knowledge to work in any of the clinical production areas including cell culture and purification. Although the candidate may be hired to work primarily in a particular area, they are expected to have the scientific acumen to quickly adapt to cross-functional training as needed to advance pipeline projects. In addition, the position will provide support for process analytics related to CPV.

The colleague will work with some direct supervision and is responsible for the executing the design, optimization, implementation, troubleshooting, scale-up, tracking and reporting of a variety of manufacturing processes for clinical and launch campaigns of monoclonal and bispecific antibody programs.  You must also be able to maintain GMP documentation essential and documenting the manufacture of clinical and commercial grade material and comply with applicable safety, occupational health, loss prevention and environmental requirements.

This role may additionally support commercial manufacturing of established products at the site, executing CPV and process monitoring to ensure product quality is maintained. The role is expected to be flexible to support different products as required and is expected to be able to learn quickly and adapt to changing business.

What You Will Achieve

Participate in clinical product transfer, production and capital projects in a technical capacity.  Perform technical transfer and process engineering activities by working with senior level colleagues and supervision to implement processes in the manufacturing areas.  This may include assisting in technical transfer of processes from development laboratories and small-scale pilot areas into the clinical production areas, as well as technical transfer from clinical to commercial facilities.

You will be able to perform:

Participate in clinical product transfer, production, and capital projects in a technical capacity.Assist in technical transfer and process engineering activities from development laboratories to clinical and commercial production areas.Provide process engineering knowledge in process design, implementation, and testing during engineering projects.Develop new process procedures and review them with the SEM automation team and Technical Operations team.Review, recommend, and execute process improvements and optimizations to existing processes.Create, edit, and maintain SOPs, Master Batch Records, and Compounding Records for new processes.Collaborate with development personnel during engineering practice runs to introduce new product candidate processes.Maintain accurate records of process and analytical data and contribute to meetings and presentations.Support equipment preparation and operation in controlled and classified areas.Adhere to site safety standards, participate in safety training events, and enforce safety and biosafety requirements.

Here Is What You Need (Minimum Requirements)

High school diploma (or equivalent) with 10+ years of experience or associate’s degree with 8+ years of experience or BA/BS with 4+ years of experience or MBA/MS with 2+ years of relevant experience .Strong technical skills in process development and optimizationProficiency in data analysis and interpretationExperience with project management tools and methodologiesKnowledge of regulatory requirements and compliance standardsProficiency in Microsoft Office Suite

Bonus Points If You Have (Preferred Requirements)

Experience in the pharmaceutical or biotechnology industryFamiliarity with Good Manufacturing Practices (GMP)Experience with technology transfer projectsExperience with statistical software (e.g., Minitab, JMP)Ability to mentor and develop junior team members

 Physical/Mental Requirements:

Some standing, ladder climbing, bending, pushing and lifting (up to 40 lbs.) may be required on a daily basis when the colleague is supporting work in manufacturing.  Other job functions require working in an office setting where sitting and computer usage would be the norm.Ability to work collaboratively in a team environmentStrong communication skills, both written and verbalAbility to lead cross-functional teamsStrong organizational skillsAdaptability and flexibility in a dynamic work environment

Non-Standard Work Schedule, Travel, or Environment Requirements

Schedule is primarily day shift, but at times it will be necessary to work according to the manufacturing shift schedules (1st, 2nd or 3rd shift) to support execution of batch records when manufacturing batches during a tech transfer.

Other Job Details:

Last day to Apply: July 15th, 2025Eligible for Relocation Assistance: NoWork Location Assignment: On Premise

The annual base salary for this position ranges from $80 300,00 to $133 900,00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10,0% of the base salary. 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 Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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.  This position requires permanent work authorization in the United States.

Engineering

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