API Process Supervisor

We are seeking a chemist/chemical engineer to join the Chemical Research and Development (CRD) Manufacturing team in Groton. The successful candidate will join a dynamic team responsible for manufacture of API at kilo lab scale. They will apply safety specific scale up principles, coordination and documentation for process understanding and manufacture.

CRD, as part of Worldwide R&D in Pharmaceutical Sciences, is responsible for the development of process technology for the production of API in support of toxicology and clinical trial programs. CRD scientists and manufacturing specialists partner to carry out API synthesis in kilo-lab and pilot plant facilities, as well as provide support for technology transfer to Pfizer manufacturing sites and third party facilities.

The successful candidate, working closely with other chemists, engineers, analysts and quality organizations, will lead the technology transfer and scale up of the developed process in our kilo lab facility. Given the dynamic team environment, strong interpersonal and communication skills are essential.

The Process Supervisor will be responsible for oversight of API manufacturing activities in a research kilogram laboratory. Responsibilities include:

• Interfacing with process chemists (locally and from other Pfizer sites) to ensure that processes are safe and operable within the facility
• Process safety: lead process safety reviews, interface with Process Safety lab to understand all process safety testing data, identify and implement safety improvements, apply knowledge of all processing equipment design specifications including pressure ratings, vent sizes, relief design, containment capabilities etc.
• Development of manufacturing instructions, including use of an electronic notebook platform to generate batch records in both paper and electronic form
• Raw material ordering and tracking
• On the floor monitoring/supervision of API manufacturing processes
• Process and equipment troubleshooting
• Engagement with kilo lab technicians to ensure a complete understanding of the process and facilitate input on potential process improvements
• Interface with process chemists, analysts, materials management, and QA to ensure alignment of all activities necessary to support production
• Author campaign summaries to capture process performance, cost, and suggestions for future development and manufacturing strategies
• Routinely leverage existing new technologies such as Process Analytical Technologies and high shear wet milling to increase efficiency and maximize process learnings from each manufacturing run

Qualifications

Education:

• Minimum: BS in Chemistry or Chemical Engineering with 5 years of experience in process engineering/supervision or process development. Applicant must be proficient in knowledge of cGMP and process safety. The applicant must be able to work effectively in a multidisciplinary team environment.

Required Skills:

• A good foundational understanding of organic chemistry
• Working knowledge of chemical engineering principles including; reaction kinetics, thermodynamics, heat and mass transport, and reactor design
• Excellent interpersonal and communication skills

Preferred Skills:

• Experience in direct scale-up of laboratory processes in kilo lab facilities
• Prior project management experienceExperience using automated reactors and associated equipment (dosing pumps, pH meters, etc)
• Experience in authoring laboratory and/or manufacturing process tech transfer instructions
• Familiarity with eLN (electronic Lab Notebook) and Axis360 (Inventory Management) software platforms
• Fundamental knowledge of UPLC, MS, and NMR
• Working knowledge of application of in-situ analysis tools to process understanding including: FTIR, FBRM, UV/Vis
• Working knowledge of property prediction and simulation computational tools including: DynoChem, Visimix, Aspen, and Cosmotherm

PHYSICAL/MENTAL REQUIREMENTS

Manufacturing facility presence requires ambulatory access. Abilities to understand chemical synthetic schemes and reaction kinetics, to perform mathematical calculations and complex data analyses, and to develop detailed project plans are musts.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional after hour and weekend presence in support of manufacturing operations is expected. Some travel associated with technology transfer to CRD pilot plant and PGS new product launch site may be required .

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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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