Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Process Lead to join our Production team. The Process Lead is responsible for coordinating production activities of shift and/or team, including assigning tasks and training employees. The incumbent will also assist in conducting chemical syntheses/manufacture of active pharmaceutical ingredients (APIs), their intermediates and other materials according to applicable SOPs, batch records, and current Good Manufacturing Practices (cGMP).
To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required:
The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
In August 2016, Ash Stevens, Inc. was acquired by Piramal Pharma Solutions (PPS), a world leader in pharmaceutical manufacturing. In partnering with Piramal Pharma Solutions, Ash Stevens rounds out an on-going effort to offer strategic partnerships and a total solutions approach to our customers. PPS has three North American locations – a sterile injectable facility in Lexington, Kentucky; a complex, high value API facility in Toronto, Canada, and Ash Stevens, LLC (D.B.A. PPS-Riverview), a high-potency API facility, located in Riverview, Michigan.
PPS-Riverview is a full-service pharmaceutical contract manufacturer (CMO) offering comprehensive small-molecule drug substance development and cGMP manufacturing services of active pharmaceutical ingredients (APIs). With over five decades of experience, PPS-Riverview is committed to providing the highest quality of service and delivering on time, and on budget.
PPS-Riverview has extensive experience developing and manufacturing APIs for Life Science companies developing innovator small-molecule therapeutics. PPS-Riverview is a long-time provider of contract research services to the National Institutes of Health and the National Cancer Institute, and has participated in the development of many important drugs through these government agencies. To date, PPS-Riverview has received fourteen FDA manufacturing approvals for innovator APIs, including a number of fast-track manufacturing approvals for the active ingredients for the oncology drugs Velcade®, Vidaza®, Clolar® and Iclusig®.
Services offered by PPS-Riverview include process development and scale-up; cGMP manufacturing; development and cGMP manufacture of highly potent APIs using barrier-isolation technology; comprehensive analytical capabilities (including method development, stability studies and qualification of reference standards); and regulatory support for all phases of drug development and manufacturing.
What makes your company a great place to work? Family oriented environment, employee development and advancement, bonus incentive program, and professional work environment.
Positions available: Chemical Operators, Process Lead, and Technology Transfer Scientist I.
Salary is commensurate with experience.
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Where to apply on Website:
Technology Transfer Scientist