Process Development Scientist (Riverview)

Piramal Pharma Solutions HPAPI Research and Manufacturing facility, located in Riverview, Michigan (Ash Stevens, LLC, hereafter referred to as PPS-Riverview), 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.

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 :

o Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.

o Long periods of standing and walking can be expected in this position.

o This position may require long periods of sitting, typing, computer entry or looking at a