Senior HPAPI Process Development Scientist

PPL Pharma Solutions Riverview LLC; Riverview (MI); On-site; USD 110,000 - 160,000; Full time

Job summary

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility in Riverview, Michigan, is seeking a qualified Process Development Scientist to join our Process Development team. The PD Scientist develops current and new manufacturing processes and supports scale-up, analytical testing, and client communications.

Candidates should have a PhD/MS/BS in Organic or Medicinal Chemistry with substantial experience in HPAPI or high-potent compounds, and a solid grasp of cGMP, safety, and regulatory

Qualifications

• PhD in Organic or Medicinal Chemistry with up to 4 years’ experience in a relevant field.
• MS in Organic or Medicinal Chemistry with up to 8 years’ experience in a relevant field.
• BS in Organic or Medicinal Chemistry with up to 12 years’ experience in a relevant field.

Responsibilities

• Develop, conduct, and manage the process development of current and new synthetic pathways including routine analytical testing (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 and operation equipment 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 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.

Skills

Organizational skills

Written and verbal communication

Independent

High potent API experience

cGMP familiarity

Education

PhD in Organic or Medicinal Chemistry

MS in Organic or Medicinal Chemistry

BS in Organic or Medicinal Chemistry

Job description

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility in Riverview, Michigan, is seeking a qualified Process Development Scientist to join our Process Development team. The PD Scientist develops current and new manufacturing processes and supports scale-up, analytical testing, and client communications.

Candidates should have a PhD/MS/BS in Organic or Medicinal Chemistry with substantial experience in HPAPI or high-potent compounds, and a solid grasp of cGMP, safety, and regulatory