Process Development Scientist

Piramal Pharma Solutions; Riverview (MI); On-site; USD 110,000 - 150,000; Full time

Job summary

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility in Riverview, Michigan seeks a senior Process Development Scientist to lead development of API processes and support analytical stability programs.

The role requires strong knowledge of organic chemistry, cGMP compliance, and the ability to manage multiple projects while communicating effectively with clients and internal teams. This position is based in Riverview, MI and works within our Process Development group.

Qualifications

• PhD in Organic or Medicinal Chemistry with up to five years' experience in a relevant field, or MS in Organic or Medicinal Chemistry
• Knowledge of organic chemistry and chemical safety
• Familiarity with cGMP, safety, and EPA requirements

Responsibilities

• Develop, conduct, and manage the process development of current and new synthetic/process pathways.
• Maintain communications with clients and ensure their requirements are met.
• Manage the production of new APIs and ensure adequate supplies of materials and equipment.
• Ensure product shipments meet customer and regulatory requirements.
• Write progress reports and provide technical support in meetings regarding API production and process development.
• Ensure that approved processes are carried out according to cGMP guidelines and properly documented.
• Keep QA/QC updated on project requirements and schedules; assist in transfer of new processes to the plant.
• Prepare reports for management and clients.
• Maintain notebooks and complete production/cleaning records as required.

Skills

Organizational skills

Communication skills

Project management

Chemical reasoning

cGMP & EPA knowledge

Education

PhD in Organic or Medicinal Chemistry

MS in Organic or Medicinal Chemistry

Job description

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility, located in Riverview, Michigan, is seeking a qualified (Senior) Process Development Scientist to join our Process Development team. The PD Scientist is responsible for providing analytical support to the stability and reference standard programs.

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 RESPONSIBILITIES.

• Develop, conduct, and/or manage the process development of current and new synthetic/process pathways.
• Maintain communications with clients and ensure their requirements are met.
• Manage the production of new 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 regards 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 Senior PD Scientist, a candidate must have: o PhD in Organic or Medicinal Chemistry and up to five (5) years’ experience in a relevant field; OR o MS in Organic or Medicinal
• Qualified candidates not meeting the above education/experience requirements will enter as a PD Scientist.
• 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.
• Familiarity with cGMP, plant safety, and EPA requirements.

JOB CONDITIONS.

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. If any accommodations are needed, requests should be made to our Human Resources department.

Physical Demands:

• Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
• Long periods of standing and walking can be expected in this position.
• This position may require long periods of sitting, typing, computer entry or looking at a