Location: Riverview, Michigan
Entity/Division: Ash Stevens, LLC., a division of Piramal Pharma Solutions
POSITION SUMMARY: The [Senior] Process Development (PD) Chemist is responsible for the development of current and new manufacturing processes under the supervision of a senior member of the group.
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.
Shall adhere to all regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
Consistent support and practice of all Ash Stevens' mission and values.
Carries assigned tasks under the supervision of a senior member of the group.
Develop, conduct, and/or manage the process development of current and new synthetic/process pathways under minimal supervision.
Maintain communications with clients and ensure their requirements are met.
Manage the production of new APIs. Ensure that adequate supplies of process materials (raw materials, solvents, reagents, etc.) and operation equipment (hoses, reactors, glassware, etc.) are available for assigned tasks.
Ensure that product shipments meet customer and regulatory (FDA, EPA, OSHA, etc.) 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 cGMP guidelines and are properly documented.
Keep Quality Assurance and Quality Control departments updated in regards to project/client requirements and schedules. Participate in the development, training, and transfer of new processes into the plant. Maintain accurate inventories of materials.
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 (dispensing record, BPRs, cleaning records, deviation reports, etc.) related to production and cleaning is accordance with regulatory requirements.
Generate and/or evaluate standard operating procedures as required.
Provide technical support for chemical operators, engineering, quality control, etc.
To be qualified as a Senior PD Scientist, a candidate must have:
PhD in Organic or Medicinal Chemistry and up to five (5) years experience in a relevant field; OR
MS in Organic or Medicinal Chemistry and up to ten (10) years experience in a relevant field; OR
BS in Organic or Medicinal Chemistry and up to fifteen (15) years experience in a relevant field
Qualified candidates not meeting the above education/experience requirements will enter as a PD Scientist.
Knowledge of organic chemistry and chemical safety.
Excellent organizational and planning skills.
Strong written, verbal, and interpersonal communication skills.
Self-motivated, creative, and independent.
Ability to work on projects covering a variety of chemical compounds with minimum supervision.
Familiarity with cGMP, plant safety, and EPA requirements is desired.
Physical demands and work environment:
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.
Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
This position may require long periods of sitting, typing, computer entry or looking at a computer.
Ash Stevens is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all ASI staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes.
Potential limited exposure to hazardous chemicals.
Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.
Ash Stevens 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, Ash Stevens is committed to providing the highest quality of service and delivering on time, and on budget.
In August 2016, Ash Stevens 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, a high-potency API facility, located in Riverview, Michigan.
Ash Stevens has extensive experience developing and manufacturing APIs for Life Science companies developing innovator small-molecule therapeutics. Ash Stevens 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, Ash Stevens 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 Ash Stevens 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.
Piramal Enterprises Ltd.