ROLE SUMMARYAccountable for supporting activities involved in the design, development, transfer, and lifecycle management of manufacturing processes for sterile pharmaceutical products. The candidate selected will be a
subject matter expert for PC1 Lifecycle & Lyophilization.
Applies scientific and engineering principles to support the transfer of technology from development into manufacturing, including evaluation of process variability, scale-up considerations, and operational constraints. Contributes to the development of robust, compliant, and scalable manufacturing processes, including new or revised process designs. Designs and executes experimental studies, analyzes process performance, and supports process control strategies to ensure consistent product quality. Serves as a technical resource for process-related issues, supporting troubleshooting efforts and resolving moderately complex manufacturing and equipment-related problems.
Operates as a strong individual contributor, applying comprehensive knowledge of the discipline, working independently on routine activities, and exercising judgment to resolve moderately complex problems while receiving guidance on more complex challenges.
ROLE RESPONSIBILITIESProcess Design, Development & Technical Execution- Support the design, development, evaluation, and implementation of new or revised manufacturing processes in collaboration with Co-Dev teams and manufacturing operations.
- Design and execute experimental protocols, studies, and measurements to evaluate process performance, variability, scalability, and control of critical process variables.
Scientific Studies & Data Analysis- Conduct laboratory and engineering studies and analyze data to support product understanding, process performance, technical decision-making, and process improvements.
- Author and review technical reports and provide input on product characterization and analytical methodologies, ensuring scientific rigor and inspection readiness.
Investigations, Troubleshooting & Problem Solving- Lead or support investigations related to deviations, discrepancies, and process performance issues, including root cause analysis and development of effective CAPA.
- Troubleshoot and resolve process and equipment-related challenges in commercial manufacturing while serving as a scientific and technical representative for facility process issues.
PC1 Product Lifecycle Management- Support end-to-end lifecycle activities for PC1 products, including technology transfer, scale-up, process validation, CPV monitoring, change control, and post-approval change implementation.
- Develop technical impact assessments, support change execution plans, and collaborate cross-functionally to ensure process robustness, compliance, supply continuity, and continuous improvement.
Lyophilization SME (Lyo) Support- Serve as a Technical Services SME for lyophilization, providing technical support for cycle understanding and optimization, equipment capability, process performance evaluation, and troubleshooting of lyo-related product or process issues.
- Support development of process understanding and control strategies for lyophilization operations.
Process Improvement & Change Management- Support process and product improvements, including application of process analytical technologies (PAT) and evaluation and implementation of process, equipment, and system changes.
- Assist in developing and updating technical documentation and procedures, and provide technical support and training to operations and technical staff.
Cross-Functional Collaboration & Project Contribution- Work independently or as part of project teams to achieve technical objectives and contribute to moderately complex projects impacting the department.
- Provide technical recommendations and solutions for moderately complex problems in collaboration with Operations, Quality, Validation, and Engineering.
BASIC QUALIFICATIONS- Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
- Experience in Technical Services, Manufacturing Science & Technology (MS&T), or pharmaceutical manufacturing
- Demonstrated experience in:
- Process development, validation, or technology transfer
- Investigations and troubleshooting of manufacturing processes
- Working knowledge of cGMP and regulatory requirements
- Strong analytical, problem-solving, and communication skills
PREFERRED QUALIFICATIONS- Experience supporting product lifecycle management activities (CPV, change control, Post Approval Changes)
- Experience with sterile injectable manufacturing processes
- Experience with lyophilization process development or troubleshooting
- Experience working in cross-functional and project team environments
- Familiarity with digital or AI tools to support data analysis and productivity
Work Location Assignment: Hybrid
Limited travel required. Some non-standard work hours support of global conference calls, 24/7 manufacturing, etc. required when needed, though not typical of weekly requirements.
OTHER JOB DETAILS
Last Date to Apply for Job: Sep 3rd, 2026.
Referral Bonus Eligibility: YES
Eligible for Relocation Package: Yes
The annual base salary for this position ranges from $99,200.00 to $165,400.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. 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.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Engineering
