The Scientist I / Sr. Chemist will play a key role in maintaining GMP and regulatory standards, through method validation, analytical testing to ensure quality and compliance of raw materials. This is a highly visible, hands-on role ideal for a self-starter who can operate independently and drive validation activities from start to finish.
1. Responsibilities of the Scientist I / Sr. Chemist- Lead execution of method validation, verification, and development activities
- Perform analytical testing on raw materials and finished products
- Support analytical method development for OTC formulations
- Execute validation protocols in alignment with ICH, USP, and cGMP standards
- Assist with implementation of new testing capabilities, including dissolution equipment
- Conduct data analysis, interpretation, and technical documentation/reporting
- Collaborate closely with QC leadership and cross-functional teams
- Support activities within the R&D laboratory environment
- Maintain compliance with regulatory requirements and data integrity standards
- Work independently with minimal supervision in a fast-paced environment
2. Qualifications of the Scientist I / Sr. Chemist- BS or MS in Chemistry or related scientific discipline
- 4+ years of experience in a pharmaceutical or highly regulated QC laboratory
- Strong, hands-on experience with method validation (critical requirement)
- Experience with method development and verification
- Proven ability to work independently and execute validations end-to-end
- Strong understanding of cGMP, USP/compendial testing, and regulatory expectations
- Experience with HPLC and GC instrumentation
- Excellent problem-solving, communication, and organizational skills
3. Compensation for the Scientist I / Sr. Chemist- Hourly Rate: $40 - $53 per hour (depending on experience level)
- Comprehensive Benefits: Medical (Cigna), Dental (Cigna), Vision (Cigna), 401K with match (ADP Retirement), PTO, and Holidays
4. KeywordsMethod Validation, Method Development, Method Verification, HPLC, GC, Dissolution Testing, OTC, Solid Oral Dose, Pharmaceutical QC, cGMP, USP, ICH, Analytical Chemistry, R&D Lab, Data Integrity
