Director, Process Development

PPL Pharma Solutions Riverview LLC; Riverview (MI); On-site; USD 140,000 - 210,000; Full time

Job summary

Piramal Pharma Solutions Riverview is seeking a Director of Process Development to lead the chemical process development for API synthesis at the Riverview facility. You will coordinate with QA, QC, Safety, Engineering and Operations to ensure contractual and cGMP requirements are met while providing regular client updates.

The role involves directing staff, coordinating with senior leaders, and ensuring safe and efficient lab and plant operations, with a focus on scalable manufacturing

Qualifications

• Proven skills in project management methodology and application.
• Advanced knowledge of synthetic organic and process chemistry.
• Strong knowledge of pilot plant and kilo lab production under cGMP.
• Understanding of CMC, regulatory affairs is a strong asset.

Responsibilities

• Assess new projects to identify optimal chemical routes and resources.
• Lead department meetings and coordinate with Process Development managers.
• Ensure timeliness, specs, and FDA compliance across projects.
• Develop process R&D plans to enable on-time delivery of objectives.
• Provide technical opinions for safe, economical manufacturing processes.

Skills

Project management

Organic chemistry

Process development

Leadership

cGMP understanding

Education

Master or Ph.D. in Organic Chemistry, Medicinal Chemistry, or Chemical Engineering

Job description

Be the First to Apply Division Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com

Job Title

Director, Process Development

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.

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

• 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.

Job Competencies and Critical Attributes

• EHS Focus
• Passionately Reliable
• Rapid Responsiveness
• Innovative Efficiency
• Staff Leadership
• Strategic Thinking
• 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.

Physical demands and work environment

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical Demands: Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected. Long periods of sitting and walking may also be expected. This position may require long periods of sitting, typing, computer entry or looking at a computer.

Work Environment

Potential limited exposure to hazardous chemicals. Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the-counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group. PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.