Use Your Power for Purpose
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)
- BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience
- Strong technical skills in process development and optimization
- Proficiency in data analysis and interpretation
- Experience with project management tools and methodologies
- Knowledge of regulatory requirements and compliance standards
- Proficiency in Microsoft Office Suite
Bonus Points If You Have (Preferred Requirements)
- Experience in the pharmaceutical or biotechnology industry
- Familiarity with Good Manufacturing Practices (GMP)
- Experience with technology transfer projects
- Experience 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 environment
- Strong communication skills, both written and verbal
- Ability to lead cross-functional teams
- Strong organizational skills
- Adaptability 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: August 26th, 2025
- Work Location Assignment: On Premise
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.
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