Director Process Development

Piramal Pharma Solutions; Riverview (MI); On-site; USD 150,000 - 210,000; Full time

Job summary

Piramal Pharma Solutions’ Riverview facility seeks a Director of Process Development to lead the planning and organization of activities for API process development, ensuring timelines, specifications, cGMP compliance, and contract terms are met. Collaboration across QA, QC, Safety, Engineering and Operations will be essential for resourcing and client communication.

The role requires strong project management, team leadership, and deep knowledge of organic synthesis and process chemistry, with

Qualifications

• Master or PhD in Organic Chemistry, Medicinal Chemistry or Chemical Engineering.
• Minimum five years’ experience in research and chemical development of drugs and fine chemicals.
• Strong knowledge of classic and modern synthetic methods; leadership of research teams.

Responsibilities

• Assess new projects to identify optimal chemical routes and resources.
• Coordinate with Process Development leadership to allocate resources and staff.
• Lead regular department meetings and project leadership activities.
• Ensure timelines, specifications and FDA requirements are met with resource efficiency.
• Develop process development plans to achieve timely project delivery.
• Direct safe, compliant lab operations under cGMP.
• Conduct literature reviews to identify feasible routes and solutions.
• Collaborate with Analytical Development on in-process methods.

Skills

Project management

Synthetic organic chemistry

Process chemistry

cGMP knowledge

Regulatory affairs

Team leadership

Education

Master's or PhD in Organic Chemistry, Medicinal Chemistry, or Chemical Engineering

Job description

The Director, Process Development will serve as a member of the technical leadership for the development of new processes for the synthesis of API or API candidates at Piramal Pharma Solutions’ Riverview manufacturing facility. The incumbent will help with the planning and organization of some activities in the Chemical Process Development department to ensure that timelines, specifications, cGMP requirements, and the other terms of contracts are fully respected. You will collaborate and interact with the other departments of PPS-Riverview (Quality Assurance, Quality Control, Safety, Engineering, Operations, etc.) so that all resources required for developing and approving a process are in place. Periodically this role will inform the client with the status of the project. This role may participate in potential new project assessments to provide Site Leadership with technical input regarding the feasibility of the project and may also prepare technical reports and participate in the site management meetings/team.

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 regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
• Consistent support and practice of all Ash Stevens’ mission and values.
• Identify and protect the original technical information as part of the company property.

Key accountabilities:

• May be asked to assess new projects with the department in order to identify the best chemical route and resources to be used in order to develop a process.
• Collaborate with Sr. Director & Regional API R&D Lead in allocating project resources (lab space, equipment and staff)
• Provide leadership to staff in regular departmental meetings, regular meetings with Managers of Process Development, and R+D project leadership roles
• Organize work within Process Development to ensure that timeliness, specifications, and FDA requirements are respected and correlate with most effective and economic use of the resources.
• Develops process research & development project plans in collaboration with the Process Development managers and other departments to ensure OTIF delivery of overall project objectives
• Ensure safe and clean lab operations
• Conduct literature searches and laboratory work to quickly identify the potential and limitations of different routes and propose the optimal solution for development.
• Contribute to the efforts to identify, characterize, and synthesize by-products and impurities generated in different steps of a process and find the conditions to diminish/suppress or remove them.
• Participate in regular departmental meetings with direct reports.
• Working with Analytical Development, direct the development of “in-process methods” to monitor chemical processes.
• Provide technical opinions and recommendations to the members of the Process Development Department in order to elaborate chemical manufacturing processes that are safe, economical, and in compliance with cGMP requirements.
• Work in the laboratory or plant (hands‑on) as required.
• Generate, verify, approve, and revise BPRs, specifications, deviation reports, and development reports.
• Actively participate in technical talks to find solutions to different problems and carefully consider opinions and suggestions for future work.
• Periodically interact with Production, Analytical Development, Tech Transfer, QA, QC, Engineering, Safety, and other departments to ensure all aspects of a project under development are being taken into consideration.
• Identify and protect the original technical information as part of the company property.
• Promote a friendly and cooperative environment for all members of the department in order to facilitate open communication. Strongly encourage teamwork and carefully consider and analyze other people’s opinions. Participate in meetings with potential clients and brokers to provide input to ASI’s Senior Management about technical aspects of potential business opportunities for the company. Interact with clients in a positive and constructive manner.
• Work with clients for an efficient transfer and implementation of the technological /analytical information.
• Actively participate in technical talks to find solutions to different problems and carefully consider other opinions and suggestions for future work.

EDUCATION/EXPERIENCE:

• Master or Ph.D. in Organic Chemistry, Medicinal Chemistry, or Chemical Engineering.
• Minimum Five (5) years’ experience in research and chemical development of drugs and fine chemicals, with a proven track record of contribution in the field.
• Wide knowledge of classic and modern synthetic methods (excluding Chemical Engineers).
• Up to five (5) years of successful track record of building and managing research teams.
• Familiar with project management tools and best practices.

SKILLS & KNOWLEDGE:

• Proven skills and knowledge in project management methodology and application.
• Advanced knowledge of synthetic organic and process chemistry.
• Strong knowledge and skills with production capabilities in a pilot plant and kilo lab environments operating under current Good Manufacturing Practices (cGMP).
• Understanding of pharmaceutical drug development (Chemistry, Manufacturing and Controls; “CMC”), analytical chemistry and regulatory affairs is a strong asset.
• In depth knowledge and skills in operational leadership including resource management skills.