JOB PURPOSE & SUMMARY OF POSITION
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.
QUALIFICATIONS, KNOWLEDGE, & EXPERIENCE
- 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.