1+ months

Senior Associate API Manufacturing Process Technologist

Pfizer
Groton, CT 06340
**Role Summary**



We are seeking candidates for a Process Technologist role in the API Manufacturing group within Chemical Research and Development (CRD) in Groton. CRD, as part of Worldwide R&D in Pharmaceutical Sciences, is responsible for the development of process technology for the production of active pharmaceutical ingredients (API).



Process Technologists are involved in the planning, execution (hands on operations) and oversight of scale up activities to manufacture pharmaceutical drug candidates in a cGMP environment to supply toxicology and clinical studies.



The Process Technologist may also play an important hands on role in the implementation of emerging manufacturing technologies, from design and testing through to clinical and toxicology study supply manufacture.



The Process Technologist will work on and may lead multi-disciplinary teams involving chemists, analysts, quality, and safety. The successful individual should also be completely comfortable dealing with constantly changing timelines and workload.



**Role Responsibilities**



+ For assigned reload campaigns, provide technical project management and scale up chemistry transfer in support of API manufacture.

+ For assigned first-run manufacturing steps:

+ Responsible for supervisory support, detailed execution planning, and process troubleshooting for API manufacture.

+ Responsible for overall data review and documentation detailing the science, safety, and cGMP execution of processing in the API manufacturing facilities.

+ Interfacing with process chemists to ensure that processes are safe and operable.

+ Process safety: lead process safety reviews, interface with Process Safety lab to understand all process safety testing data, identify and implement safety improvements, order and track raw materials required for manufacture.

+ Will interact with Quality Assurance, Inventory Management, Analytical Research and Development, Environmental Health & Safety, and Process Chemistry to support manufacture.

+ Work with API Manufacturing staff, CRD Chemists and Engineers, equipment and instrumentation vendors, GO and contracted trades workers to plan, install, and effectively deploy new manufacturing technologies.



**Qualifications:**



Educational Requirements:



+ Minimum BS in relevant scientific discipline (Chemistry, Biology, Engineering) with at least 2 years experience in a Chemical Laboratory or Manufacturing role.



Technical Skill Requirements:



+ Candidate must be proficient in cGMP approaches for pharmaceutical manufacturing, and possess excellent oral and written communication skill, attention to details and a demonstrated ability to work effectively in a cross discipline team environment.

+ Candidate must demonstrate an ability to accommodate changes in shift production and project execution plans quickly, safely and within full GMP compliance.

+ Candidate must have proven mechanical capabilities, and have a sound working knowledge of CRD Process Safety practices, Biovia eLN software, and MS Office software elements.

+ Prior experience or education in organic synthesis fundamentals (including training in the handling of highly hazardous, reactive, and flammable materials) is highly desired.



**PHYSICAL/MENTAL REQUIREMENTS**



+ Candidate must be physically capable of sitting or standing for prolonged periods, able to lift in excess of 50 lbs.

+ Able to be amenable to wearing personal protective equipment and working with hazardous materials.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



Candidate must be able and willing to work on a rotating shift schedule (day shift and afternoon shift) as assigned.

Relocation support available



**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.



Manufacturing



\#LI-PFE

Categories

Posted: 2021-08-20 Expires: 2021-10-30

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Senior Associate API Manufacturing Process Technologist

Pfizer
Groton, CT 06340

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