POSITION SUMMARY:

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility, located in Riverview, Michigan (Ash Stevens, LLC, hereafter referred to as PPS-Riverview), is seeking a qualified Process Development Scientist to join our Process Development team. The PD Scientist is responsible for the development of current and new manufacturing processes.

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 applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
• Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
• Identify and protect the original technical information as part of the company property.

KEY RESPONSIBILIES:

• Develop, conduct, and/or manage the process development of current and new synthetic/process pathways including routine analytical testing to monitor process progress (HPLC, NMR, XRPD, GC-HS, KF, etc.).
• Handling of highly potent compounds and experience in synthesis and handling of Linker-Payloads is highly desirable.
• Scale-up preparative HPLC purification and lyophilization of intermediates and final products.
• Maintain communications with clients and ensure their requirements are met.
• Manage/support the production of new (HP)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 regard 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.

EDUCATION/EXPERIENCE

• To be qualified as a PD Scientist , a candidate must have:
• PhD in Organic or Medicinal Chemistry and up to four (4) years’ experience in a relevant field; OR
• MS in Organic or Medicinal Chemistry and up to eight (8) years’ experience in a relevant field; OR
• BS in Organic or Medicinal Chemistry and up to twelve (12) years’ experience in a relevant field
• Knowledge of organic chemistry and chemical safety.

JOB COMPETENCIES

• Excellent organizational and planning skills.
• Strong written, verbal, and interpersonal communication skills.
• Self-motivated, creative, and independent.
• Ability to direct projects covering a variety of chemical compounds including high potent APIs.
• Familiarity with cGMP, plant safety, and EPA requirements.