Under the direction of a Principal Scientist, works on complex problems where analysis of situations or data requires an evaluation of intangible variables and insightful application of theoretical knowledge.
- Independently synthesize, purify, and analyse chemical intermediates and target compounds.
- Synthesize chemical intermediates or active pharmaceutical, crystallization, and distillation techniques.
- Analyze and identify compounds utilizing a range of analytical techniques.
- Keep accurate, legible, and complete records of all experiments and observations.
- Generate written progress reports and present scientific results to team members.
- Exhibit a high level of safety awareness and conduct lab operations in a safe manner.
- Assist with keeping well-maintained and clean laboratories.
- 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 Responsibilities
- 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 & 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 required by this job include: close, 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.
Are you the ideal candidate?
- Requires a minimum of a Bachelor’s Degree in Chemistry.
- Prior basic laboratory skills and a working theoretical knowledge of organic chemistry desired.
- Experience working in a Kilo-Lab environment or GMP experience is a plus.
- Ability to read and interpret English-language chemical periodicals, scientific journals, and regulatory documents.
- Ability to write clear and concise technical reports.
- Working knowledge of common MS Windows-based software and statistical software is required.