A process research and development chemist is responsible for enabling the manufacturing of Active Pharmaceutical Ingredients (APIs) 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. The Staff Chemist position requires the application of basic chemistry knowledge and standard laboratory techniques and procedures as well as an ability to make keen observations and learn how to solve more complex technical issues.
- Independently performs scientific experiments aimed at optimizing and developing the necessary understanding of chemical processes to enable larger scale manufacturing of APIs.
- Uses appropriate laboratory and process safety equipment and techniques in the course of research and development experiments.
- Applies basic chemistry knowledge and prior experience to solve simple and moderate process development problems without instruction and receives guidance on new assignments or more complex problems from a senior team member or supervisor.
- Uses a variety of analytical techniques to generate data that support the appropriate level of understanding of chemical processes such as NMR, HPLC, UV, GC, LC-MS, DSC, XRPD and KF.
- Develops an understanding of Good Manufacturing Practices (GMPs) and how to apply GMPs to the development of a process.
- Documents experiments and results in laboratory notebooks or other designated forms.
- Prepares summary reports on findings and presents scientific results and observations to project team and clients with guidance from a senior team member or supervisor.
- Participates in project management activities including: purchasing materials and meeting timelines, budgets, and project goals.
- Follows all Standard Operating Procedures (SOPs).
- Other duties as assigned.
- Demonstrates technical proficiency and self-assuredness in applying cGMP standards.
- Applies cGMP concepts in association with department specific responsibilities.
- Ensures all documentation produced is in compliance with cGMP standards.
- Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed.
- Ensures work is in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc.
ENVIRONMENTAL, HEALTH, & SAFETY RESPONSIBITILIES
- Follows and abides by all EH&S policies, practices, and procedures in association with department specific responsibilities.
- Demonstrates technical and procedural proficiency and self-assuredness in applying EH&S standards.
- Responsible for contributing to audit readiness and for participating in EH&S audits with internal Company groups, regulatory agencies, and customers.
- Responsible for reporting all near misses, accidents, and dangerous occurrences through the appropriate Company procedures to ensure an investigation is initiated.
- Cooperate with all root cause investigations and follow corrective actions and compliance with Company policies and procedures, and all state and federal regulations occurs within department.
- Support the Company’s commitment for environmental health & safety by applying ISO 14001, OHSAS 18001, and Sustainability 2025 principals into daily activities.
PHYSICAL DEMANDS AND 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.
- Must be able to lift and/or move up to 50 pounds.
- 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
- BS in Organic Chemistry or equivalent with 2-6 years of process development related experience in a pharmaceutical industry.
- MS in Organic Chemistry or equivalent with 1-4 years of process development related experience in a pharmaceutical industry.
- Ability to read, analyze, and interpret English-language chemical periodicals, scientific journals, and regulatory documents.
- Ability to write clear and concise technical reports.
- Good understanding of Microsoft Office.
- Demonstrate ability to exercise good judgment and make decisions with guidance from senior team members or supervisor.
- Good written and verbal communication skills.
- Experience with common analytical techniques such as: NMR, HPLC, UV, GC, LC-MS, DSC, XRPD and KF.
- Experience communicating effectively to management.
- Ability to work independently and in a team environment.