Process Development Manager

Piramal Pharma Solutions; Riverview (MI); On-site; USD 150,000 - 190,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Manager, Process Development to lead the development of new processes for API and HPAPI synthesis under GLP and cGMP. You will plan, organize, and manage activities to ensure timely, compliant development, reporting to the Head of Process Development and interfacing with QA, QC, Safety, Engineering, and Tech Transfer.

Strong regulatory, DOE and PD expertise are essential.

Qualifications

• Ph.D. in Organic Chemistry, Medicinal Chemistry, or Chemical Engineering.
• Five to ten years of experience in research and chemical development of drugs and fine chemicals.
• Knowledge of cGMP and regulatory requirements for API development.
• Technical experience in handling High Potent APIs (OEL < 1 µg/m3).
• DOE and statistical analysis for process parameter design.
• Strong communication and project management skills.

Responsibilities

• Oversee API and HPAPI process development and lab-scale manufacturing.
• Ensure compliance with FDA, EPA, OSHA and cGMP requirements.
• Plan and organize activities in the Chemical Process Development department.
• Lead multiple projects and manage client communications.
• Develop robust, scalable routes for drug substances.
• Prepare technical reports and participate in site management meetings.
• Collaborate with QA, QC, Safety, Engineering and Tech Transfer across departments.

Job description

The Manager, Process Development, will serve as a member of the technical leadership for the development of new processes for the synthesis of APIs or HPAPIs. The incumbent will be responsible for developing a robust, scalable route to manufacture drug substances, including HPAPIs under GLP and cGMP for clinical trials, toxicology studies, and commercial APIs. The incumbent will help plan and organize all activities in the Chemical Process Development department to ensure that timelines, specifications, cGMP requirements, and the other terms of contracts are fully respected. This position will also provide technical expertise at the request of the Head of Process Development and other departments and employees. You will collaborate and interact with the different departments (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 of the status of the project. This role will actively participate in potential new project assessments to provide Site Leadership with technical input regarding the feasibility of the project and will 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.

• Conduct and oversee API process development and lab-scale manufacturing of APIs and HPAPIs using containment, isolator technologies and operations, and applicable manufacturing safety requirements.
• Shall adhere to all regulatory requirements, including FDA, EPA, OSHA, 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 RESPONSIBILITIES:

• 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.
• Organize work within the department to ensure that timeliness, specifications, and FDA requirements are respected and correlate with most effective and economic use of the resources.
• 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.
• 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.
• Execute GMP processes for lab-scale manufacturing of APIs including highly potent APIs for clinical studies and commercial batches.
• Actively participate in technical talks to find solutions to different problems and carefully consider opinions and suggestions for future work.
• Represent Process Chemistry on multifunctional project teams collaborating with scientists from Analytical, QC, QA, and Tech Transfer to departments to ensure all aspects of a project under development and manufacture 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:

• Ph.D. in Organic Chemistry, Medicinal Chemistry, or Chemical Engineering.
• Five (5) to (10) years of experience in research and chemical development of drugs and fine chemicals, including asymmetric synthesis, green chemistry, catalysis, and physical organic chemistry related to reaction mechanisms, are expected.
• Wide knowledge of classic and modern synthetic methods (excluding Chemical Engineers) and current Good Manufacturing Processes (cGMP).
• Technical experience handling and manufacturing of High Potent APIs (OEL < 1 µg/m3).
• Technical experience in process characterization, including DOEs and statistical analysis to determine critical/key process parameters and process design space.
• Development of Preparative HPLC methods and applications on large-scale purifications.
• Experience isolation of process impurities by preparative HPLC and characterization by NMR, techniques to support fate/purge studies, and process understanding.
• Capability to effectively manage multiple projects and work independently as assigned
• Excellent written and oral communication skills, the ability to effectively influence the work of others, and general knowledge of drug development and the pharmaceutical industry.

JOB COMPETENCIES:

• Manage and advance multiple projects simultaneously, lead a team and communicate project updates to clients and upper management.
• Able to direct and interact with team members.
• Excellent organizational and planning skills.
• Strong written, verbal, and interpersonal communication skills.
• Have the ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
• Self-motivated, creative, and independent.
• Ability to manage projects covering a variety of chemical compounds.