JOB PURPOSE & SUMMARY OF POSITION
Leads the day-to-day operations of the Chemical Development team in the Devens facility through group and project leaders. The Section Head position requires an expert level understanding of process development to enable the manufacturing of Active Pharmaceutical Ingredients (APIs) under cGMPs on larger scales in a safe and reliable manner. Responsible for operational safety, performance management and continuous improvement of the team. Ensures that development projects are fit for purpose relative to clinical phase of development and on target for timeline and budget. Collaborates with the heads of the other functions and clients to resolve problems and drive right first time performance for the team. Reviews and provides input on proposals, standard operating procedures and other technical documentation.
- Manages through others and is fully accountable for all aspects of Chemical Development projects and performance.
- Ensures project leaders design appropriate plans to meet project goals within the required timeline and budget.
- Mentors, leads, and advises the chemistry group in areas of technical, regulatory, quality, project management, client interaction, and safety topics.
- Defines appropriate performance and career objectives for group and project leaders and helps group leaders define appropriate performance and career objectives for junior scientists and/or chemists.
- Manages performance of the Chemical Development team through coaching and feedback.
- Drives continuous improvement throughout team to enable improved process understanding and tech transfer to ensure right first time scale up of processes.
- Expert process development chemist with an in-depth understanding of how to develop processes to support GMP manufacturing in a variety of kilo-lab and plant equipment across all phases of clinical development.
- Exhibits a high level of safety awareness and ensures lab operations are conducted in a safe manner.
- Schedules resources interactively with business development and project management and continually assesses resources while making the necessary modifications to meet future needs.
- Recommends potential courses of action to senior management for enhancing capabilities and workflows by monitoring and analyzing trends within the team and developing well thought out plans.
- Able to clearly communicate verbally and in writing to clients and management.
- Reviews and provides input on proposals, standard operating procedures and other technical documentation.
- Other duties as assigned.
- Manages staff in full compliance with cGMP requirements.
- Responsible for departmental audit readiness and for participating in quality audits with FDA and customers.
- Ensures staff acts in accordance with Johnson Matthey quality policies and practices with respect to cGMP and other related requirements.
- Manages compliance with state and federal regulations, including but not limited to GMP, DEA, and FDA.
- Implements and applies cGMP concepts in association with department specific responsibilities.
- Demonstrates technical expertise and self-assuredness in applying cGMP standards.
ENVIRONMENTAL, HEALTH, & SAFETY RESPONSIBILITIES
- Manages staff in full compliance with all appropriate EH&S policies and procedures.
- Responsible for departmental audit readiness and for participating in audits with internal Company groups, regulatory agencies, and customers.
- Ensures staff acts in accordance with EH&S policies, practices and procedures.
- Addresses staff issues accordingly if there are EH&S violations.
- Actively participates in root cause investigations on near misses and all incidents. Once identified, ensures corrective actions take place and compliance with Company policies and procedures, and all state and federal regulations occurs within the responsible department.
- Manages compliance with state and federal regulations, including but not limited to EPA, DEP, and OSHA, etc.
- Implements, applies and places emphasis on EH&S concepts with department specific responsibilities.
- Demonstrated technical and procedural expertise and self-assuredness in applying EH&S policies and procedures.
- Support the Company’s commitment for environmental health & safety by applying ISO 14001 and Sustainability 2025 principals into daily activities.
PHYSICAL DEMANDS & WORK ENVIRONMENT
- While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.
- Moderate travel may be necessary for technical meetings and/or Client visits.
QUALIFICATIONS, KNOWLEDGE, & EXPERIENCE
- PhD in Organic Chemistry or equivalent with >10 years of process development related experience in a pharmaceutical industry.
- MS in Organic Chemistry or equivalent with >14 years of process development related experience in a pharmaceutical industry.
- BS in Organic Chemistry or equivalent with >18 years of process development related experience in a pharmaceutical industry.
- Possesses ability to lead, coach and develop a team of multiple experience and skill levels. Exhibits an adaptive management style with an ability to positively resolve conflict.
- Demonstrates strong analytical, written and verbal communication skills. Possesses the ability to write clear and concise technical reports, presentations, and business correspondence.
- Effectively interfaces with internal and external clients, interdepartmental teams, and all levels of management, with a strong ability to lead through influence.
- Ability to provide direction to all levels of laboratory personnel
- Ability to plan, organize, and oversee multiple independent development or production programs.
- Experienced in developing and optimizing synthetic routes and producing and/or scaling up intermediates and API processes.
- Experience with Design of Experiments (DoE)
- Understanding of process safety concepts and how to incorporate them into process development plans to ensure processes are safe upon scale up.
- Ability to read, analyze, and interpret English-language chemical periodicals, scientific journals, and regulatory documents.
- Extensive knowledge of Microsoft Office.
- Ability to define problems, collect relevant data, recognize patterns, and draw conclusions from disparate information streams. Makes well informed decisions in a timely manner.
- Knowledge of analytical techniques (HPLC, GC, NMR, XRPD, DSC, KF, UV, LC-MS, PH meter).
- Knowledge of MS Project. Experience in establishing integrated plans within resource and task constraints.
- Experience reading and interpreting intellectual property.
- Experience with drafting CMC sections for DMFs for other regulatory filings
- Experience with flow chemistry
- Experience working with controlled substances
- Experience with DynoChem or other modeling software
- Experience working in a GMP production environment