Director, Process Development

Piramal Pharma•Riverview, MI

About The Position

The Director, Process Development is a member of the technical leadership team responsible for developing new processes to synthesize APIs and API candidates at Piramal Pharma Solutions’ Riverview manufacturing facility. The role helps plan and organize Chemical Process Development activities to ensure project timelines, specifications, cGMP requirements, and contract terms are met. It collaborates with site departments to ensure that the resources needed to develop and approve processes are in place, provides periodic project updates to clients, and may contribute technical assessments of prospective projects and participate in site management meetings. The Director provides leadership to Process Development staff, coordinates project resources and plans, and guides the development of safe, economical, effective chemical manufacturing processes that comply with cGMP requirements. The position includes laboratory or plant work as needed, technical and regulatory documentation, collaboration across departments, and client-facing work supporting project development and technology transfer. The role requires a master’s or Ph.D. in Organic Chemistry, Medicinal Chemistry, or Chemical Engineering, along with at least five years of research and chemical development experience involving drugs and fine chemicals. The work environment may involve limited exposure to hazardous chemicals and require personal protective equipment. Physical demands include frequent lifting and other movements, as well as extended periods of sitting, walking, and computer use.

Requirements

Master’s or Ph.D. in Organic Chemistry, Medicinal Chemistry, or Chemical Engineering.
At least five years of experience in research and chemical development of drugs and fine chemicals, with a demonstrated record of contribution.
Wide knowledge of classic and modern synthetic methods, except for candidates with a Chemical Engineering background.
Proven knowledge and skills in project management methodology and its application.
Advanced knowledge of synthetic organic and process chemistry.
Strong knowledge of production capabilities in pilot plant and kilo lab environments operating under current Good Manufacturing Practices (cGMP).
In-depth operational leadership and resource management skills.
Ability to direct and interact with team members.
Excellent organizational and planning skills.
Strong written, verbal, and interpersonal communication skills.
Ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
Self-motivated, creative, and independent.
Ability to manage projects involving a variety of chemical compounds.
Ability to meet the role’s physical demands, including frequent lifting, bending, stooping, squatting, pushing, and pulling, as well as periods of sitting and walking.
Ability to work in an environment with potential limited exposure to hazardous chemicals and use required personal protective equipment.

Nice To Haves

Up to five years of successful experience building and managing research teams.
Familiarity with project management tools and best practices.
Understanding of pharmaceutical drug development (Chemistry, Manufacturing and Controls; CMC), analytical chemistry, and regulatory affairs.

Responsibilities

Assess potential projects with the department, identify suitable chemical routes, and determine resources needed for process development.
Collaborate with the Sr. Director and Regional API R&D Lead to allocate project resources, including laboratory space, equipment, and staff.
Lead staff through departmental meetings, meetings with Process Development managers, and R&D project leadership activities.
Organize Process Development work to meet timelines, specifications, and FDA requirements while making effective and economical use of resources.
Develop process research and development project plans with Process Development managers and other departments to deliver project objectives on time and in full.
Ensure safe and clean laboratory operations.
Conduct literature searches and laboratory work to assess potential routes, identify their limitations, and recommend optimal development solutions.
Help identify, characterize, and synthesize process by-products and impurities, and determine conditions to reduce, suppress, or remove them.
Work with Analytical Development to direct development of in-process methods for monitoring chemical processes.
Provide technical opinions and recommendations for developing safe, economical chemical manufacturing processes that comply with cGMP requirements.
Perform hands-on work in the laboratory or plant as required.
Generate, verify, approve, and revise batch production records, specifications, deviation reports, and development reports.
Participate in technical discussions to resolve problems and consider suggestions and opinions for future work.
Coordinate with Production, Analytical Development, Tech Transfer, QA, QC, Engineering, Safety, and other departments on project requirements.
Identify and protect original technical information as company property.
Promote a cooperative department environment, encourage teamwork, and support open communication.
Participate in meetings with prospective clients and brokers, providing technical input to senior management on potential business opportunities.
Interact constructively with clients and support efficient transfer and implementation of technological and analytical information.