HPAPI Process Development Scientist | Scale-Up & Synthesis

Piramal Pharma Ltd; Riverview (MI); On-site; USD 90,000 - 120,000; Full time

Job summary

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility in Riverview, Michigan, seeks a qualified Process Development Scientist to join the Process Development team. The PD Scientist develops current and new manufacturing processes and supports client requirements.

The role involves handling highly potent compounds, scaling up HPLC purification, documenting processes per cGMP, and providing technical support in meetings with clients and internal teams.

Qualifications

• PhD in Organic or Medicinal Chemistry with up to 4 years of relevant experience.
• MS in Organic or Medicinal Chemistry with up to 8 years of relevant experience.
• BS in Organic or Medicinal Chemistry with up to 12 years of relevant experience.
• Knowledge of organic chemistry and chemical safety.

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 and ensure adequate supplies and equipment for tasks.
• Ensure product shipments meet regulatory requirements (FDA, EPA, OSHA, etc.).
• Write progress reports and provide technical support in meetings regarding current API production and new API process development.
• Ensure approved processes are carried out according to cGMP guidelines and properly documented.
• Keep QA/QC departments updated on project/client requirements and schedules; participate in development and transfer of new processes; maintain inventories.
• Prepare appropriate reports for management and/or clients.
• Maintain notebooks, complete logbooks and documentation; generate and audit records as required.

Skills

Process development

Analytical testing

HPAPI handling

Documentation & reports

Client communication

Education

PhD in Organic or Medicinal Chemistry

MS in Organic or Medicinal Chemistry

BS in Organic or Medicinal Chemistry

Tools

HPLC

NMR

XRPD

GC-HS

KF

Job description

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility in Riverview, Michigan, seeks a qualified Process Development Scientist to join the Process Development team. The PD Scientist develops current and new manufacturing processes and supports client requirements.

The role involves handling highly potent compounds, scaling up HPLC purification, documenting processes per cGMP, and providing technical support in meetings with clients and internal teams.