JOB PURPOSE & SUMMARY OF POSITION
A group and project leader position within the process research and development team. The Senior Scientist position requires an in-depth understanding of process development to enable the manufacturing of Active Pharmaceutical Ingredients (APIs) under cGMPs on larger scales in a safe and reliable manner through creating an understanding of how chemical processes work and how those chemical processes will translate from a laboratory to a manufacturing environment. Additionally, the Senior Scientist position is expected to oversee and manage the progress and performance of more junior staff and serve as the primary client contact and lead scientist for several projects.
- Designs appropriate plans to meet project goals within the required timeline and budget.
- Mentors, leads, and advises junior scientists and/or chemists in areas of scientific, regulatory, project management, client, and safety issues. Helps define appropriate performance and career objectives for junior scientists and/or chemists.
- Manages performance of team through coaching and feedback.
- Routinely analyzes and defines problems, collects relevant data, recognizes patterns, and draws valid conclusions.
- Recommends potential courses of action to senior management by providing solid results, findings, and technical solutions to project issues / day to day problems.
- Expert in independently synthesizing, purifying and analyzing chemical intermediates and active pharmaceutical ingredients using a broad range of synthetic and analytical techniques.
- Keeps accurate, legible and complete records of all experiments and observations.
- Generates written progress reports and clearly presents scientific results to clients and management.
- Exhibits a high level of safety awareness and conducts lab operations in a safe manner as well as holds others accountable for safe behavior in the work environment.
- Multi-tasks responsibilities including: laboratory work, preparing scientific reports and documents, presenting scientific findings to clients and management, using scientific literature to solve advanced technical problems.
- Performs additional scientific tasks with a high level of independence such as:
- Continuous learning and growth in new scientific fields and/or deepening level of competence in major field of expertise.
- Evaluates potential new projects and techniques.
- Shares special skills and expertise with other team members and departments such as Analytical Development, Quality Control, Quality Assurance, and Production groups.
- Learns and follows all Standard Operating Procedures (SOPs).
- 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.
- Specific vision abilities include: near, distance, peripheral, color perception, and the ability to adjust focus.
- Regularly works with moving mechanical parts and may work with toxic or caustic chemicals. The work may be performed in humid areas with low or high temperatures.
QUALIFICATIONS, KNOWLEDGE, & EXPERIENCE
- PhD in Organic Chemistry or equivalent with 6-12 years of process development related experience in a pharmaceutical industry.
- MS in Organic Chemistry or equivalent with 10-16 years of process development related experience in a pharmaceutical industry.
- BS in Organic Chemistry or equivalent with 14-20 years of process development related experience in a pharmaceutical industry.
- Ability to lead projects and provide direction to various levels of laboratory personnel
- Ability to plan, organize, and oversee multiple independent development or production programs.
- Ability to successfully work with interdepartmental teams.
- Experienced in developing and optimizing synthetic routes and producing and/or scaling up intermediates and API processes.
- 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.
- Knowledge of analytical techniques (HPLC, GC, NMR, XRPD, DSC, KF, UV, LC-MS, PH meter).
- Experienced in communicating to all levels of management.
- Ability to write clear and concise technical reports and business correspondence.
- Strong verbal and presentation skills.
- Ability to work independently and in a team environment.
- Demonstrated ability to exercise good judgment and make decisions in a timely manner.
- Knowledge of MS Project. Experience in establishing integrated plans within resource and task constraints.
- Experience reading and interpreting intellectual property.
- Experience with Design of Experiments (DoE)