(Senior) Process Development Scientist
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Proclinical, in support of our client, are seeking an individual to fill the role of Process Development Scientist, based in Riverview, MI. The successful individual will complete their necessary duties, while adhering to all relevant health, safety and regulatory procedures, policies and practices.
Responsibilities
- Develop, conduct, and manage the development of current and new synthetic/process pathways.
- Maintain communications with clients and ensure their requirements are met.
- Manage the production of new APIs.
- Ensure that adequate supplies of process materials and operation equipment are available for assigned tasks.
- Ensure that product shipments meet customer and regulatory requirements.
- Write progress reports and provide technical support in meetings regarding current API production and new API process development.
- Ensure that approved processes are carried out according to relevant guidelines and are properly documented.
- Keep QA and Quality Control departments updated regarding project/client requirements and schedules.
- Participate in development, training, and transfer of new processes into the plant.
- Prepare appropriate reports as needed for management and/or clients.
- Maintain notebooks for research and development and non-GMP activities.
- Complete and audit production and cleaning records.
- Complete logbooks and documentation related to production and cleaning.
- Provide technical support for chemical operators, engineering, quality control, etc.
Skills And Qualifications
- PhD in Organic or Medicinal Chemistry and up to five (5) years' experience in a relevant field; OR o MS in Organic or Medicinal Chemistry and up to ten (10) years' experience in a relevant field; OR o BS in Organic or Medicinal Chemistry and up to fifteen (15) years' experience in a relevant field
- Strong written, verbal and interpersonal communication skills.
- Familiarity with cGMP, plant safety, and EPA requirements.
- Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected. o Long periods of sitting and walking may also be expected in this position.
- Ability to wear required personal protective equipment.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Andrew Shen at (+1) 646-367-1089 or upload your resume on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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