Sr Engineer / Scientist Process Development

Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve

As a Senior Scientist, you will be at the center of our operations and you'll find that everything we do, every day, is in line with an unwavering commitment to quality. You will be responsible for the development of process technology for the production of active pharmaceutical ingredients (API). From small scale synthesis in support of discovery programs, to the development of the commercial synthetic route, you will partner with manufacturing specialists for API synthesis and provide support for technology transfer to Pfizer manufacturing sites and third party facilities. Your innovative mindset will help us develop economical, efficient and safe active drug materials.

You will be recognized as a technical expert and a scientific contributor. With your deep knowledge of the discipline, you will be an active team member whose decisions impact the project. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience. You will be forecasting and planning resource requirements for your project team. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide team members.

It is your innovative scientific temperament that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Regularly contribute and influence at the project team level.
• Support technology transfer of drug substance processes to internal Pfizer API manufacturing facilities and external suppliers.
• Serve as the primary Technical Expert for the manufacturing methods, perform scientific laboratory studies, and make recommendations to improve manufacturing reliability, cost, safety, compliance and environmental performance.
• Select, develop, and apply new and existing process technologies to facilitate process design to achieve project goals.
• Assist with definition and tracking of document management plan.
• Author reports, papers and prepare oral presentations for internal and external audiences
• Participates and significantly contributes to discussions in lab and project team meetings on design of experiments (bioreactor and shake flask) and interpretation of experimental data.
• Acts as a technical resource within the upstream group. Provides formal/informal mentoring to junior colleagues within work group/project team.
• Works under limited supervision with periodic review of achievement of results and experimental approaches employed. Manages own time to meet agreed targets. Develops plans for short-term work activities on own projects.
• Ensures effective, high-quality, timely and appropriate documentation in electronic laboratory notebooks and internal technical reports; presents data/ strategy to scientists and management in appropriate internal and external venues (technical meetings, project team meetings, conferences) as appropriate.
• Contributes to safe, efficient, effective and harmonious lab environment, ensures appropriate cleanliness and status/ operability of shared or assigned lab space or equipment; strong lab citizen and collaborative team player; approaches the job with energy and commitment; frequently demonstrates initiative.
• Participate in multi-disciplinary teams to resolve complex issues
• Assist in manufacturing investigations and process troubleshooting
• Assist in authoring and review of regulatory submissions
• Communicate appropriately on activities and progress to management and key stakeholders.
• Take personal responsibility for own work, pushing self and others to exceed goals and deliver results.

Qualifications

Must-Have

• Bachelor's degree with 9+ years of experience OR
• Master's degree with 7 years of experience OR
• Ph. D. with 0-4 years ofexperience in biotechnology, engineering, data science, statistics, computer science, or related fields
• Familiarity with bioprocess development and regulatory requirements
• Proficient in aseptic technique (required)
• Proficient in benchtop bioreactor operation and associated analytical tools (required)
• Experience with bench scalecell culture and/or bacterial fermentation (required)
• An in-depth knowledge of bioreactor operations fed-batch, perfusion, and continuous modes of cell culture
• Strong trouble-shooting skills and extreme attention to detail required

Nice-to-Have

• Experience with fermentation processes for production of polysaccharides
• Prior experience developing and maintaining scale down models of commercial biopharmaceutical processes
• Prior experience in developing commercially relevant Fermentation processes to produce natural products
• Experience with control and data acquisition systems
• Demonstrated experience developing or introducing new technology into commercial processes
• Knowledge of all aspects of cell culture/fermentation, including batch, fed-batch, perfusion and harvest/clarification operations
• Familiarity with DoE and other statistical tools
• Experience with processing and interpreting large data sets
• Familiarity with regulatory filings, cGMP requirements and operational constraints

PHYSICAL/MENTAL REQUIREMENTS

Work will be performed in a typical development laboratory environment and in GLP/GMP manufacturing facilities including the operations areas of pilot plants.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional evening and weekend work
Relocation support available

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.

Research and Development

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