Associate Process Development Scientist

Piramal Enterprises Limited - Riverview, MI

Full-time - Entry Level

Riverview, MI

About the position

The Associate Process Development Scientist at Piramal Pharma Solutions is responsible for developing and managing manufacturing processes for current and new synthetic pathways. This role involves working under the supervision of a senior scientist, ensuring compliance with regulatory requirements, and maintaining communication with clients to meet their needs. The position requires a strong foundation in organic chemistry and the ability to work independently on various projects.

Responsibilities

• Carry out assigned tasks under the supervision of a senior member of the group.
• Develop, conduct, and 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 adequate supplies of process materials and operation equipment are available for assigned tasks.
• Ensure product shipments meet customer and regulatory requirements.
• 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 are properly documented.
• Keep Quality Assurance and Quality Control departments updated regarding 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 in accordance with regulatory requirements.
• Generate and/or evaluate standard operating procedures as required.
• Provide technical support for chemical operators, engineering, quality control, etc.

Requirements

• Ph.D. in Chemistry or Organic Chemistry.
• 0-3 years of research experience or postdoctoral experience.
• Excellent 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.

Nice-to-haves

• Familiarity with cGMP, plant safety, and EPA requirements.