Principle Process Development Scientist

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Sr. Process Development Scientist

Job Description

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility, located in Riverview, Michigan, 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.

Key Responsibilities

• 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.