Process Technology Sr. Associate

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 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 associates 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 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: July 15th 2025
• Eligible for Relocation Assistance: No
• Work Location Assignment:On Premise

The annual base salary for this position ranges from $80300.00 to $133900.00. In addition this position is eligible for participation in Pfizers 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 lifes 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 (). 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.

Engineering

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