Position Summary
The Associate Scientist is responsible for performing analytical research and development activities that support product and process development, regulatory filings, and successful product approvals. This role contributes to analytical method development, method transfer, method verification, method validation, and routine analytical testing to support clinical development, manufacturing, and commercial registration activities.
Working under direct and continuous supervision, the Associate Scientist will collaborate closely with Product Development and Process Transfer teams to generate accurate analytical data, provide timely data interpretation, and support drug product development through feasibility, formulation development, technology transfer, registration, validation, and commercialization phases.
Key Responsibilities
- Perform analytical research and development activities in support of pharmaceutical product and process development.
- Execute analytical testing using chromatographic and spectroscopic techniques, including HPLC, GC, UV, dissolution, and other laboratory instrumentation.
- Assist with analytical method development, method transfer, method verification, and method validation.
- Perform routine release testing and stability testing to support clinical development and commercial manufacturing.
- Generate accurate analytical data and provide timely interpretation of test results to support product development activities.
- Support feasibility studies, formulation development, technology transfer, regulatory submissions, process validation, and commercialization projects.
- Accurately execute laboratory protocols and testing procedures while maintaining a high level of data integrity.
- Maintain complete, accurate, and legible laboratory notebook documentation in accordance with Good Documentation Practices (GDP).
- Perform testing in compliance with applicable SOPs, cGMP requirements, laboratory safety procedures, and regulatory guidelines.
- Coordinate analytical activities to meet project milestones, manufacturing schedules, and customer timelines.
- Participate in laboratory process improvements and continuous improvement initiatives.
- Adhere to all safety, waste management, housekeeping, and DEA scheduled drug handling procedures where applicable.
Minimum QualificationsEducation
- Bachelor's degree (B.S.) in Chemistry, Pharmaceutical Sciences, or Life Sciences.
- Preference will be given to candidates with a concentration in Analytical Chemistry.
Experience
- Minimum of 1 year of analytical laboratory testing and/or research experience within the pharmaceutical, biotechnology, or related industry.
- Hands-on experience with analytical instrumentation such as HPLC, GC, UV, or similar laboratory equipment is required.
Required Knowledge & Technical Skills
Candidates should demonstrate knowledge and experience in the following areas:
Analytical Chemistry
- Understanding of analytical chemistry calculations, including:
- Area %
- % w/w
- ppm
- µg/mL
- Molarity
- Beer's Law
- Reference standard purity calculations (as-is, anhydrous, and dry basis)
Laboratory Techniques
- Basic understanding of chromatographic techniques, including:
- High Performance Liquid Chromatography (HPLC)
- Gas Chromatography (GC)
- Liquid Chromatography (LC)
- Dissolution testing
- Basic understanding of spectroscopic techniques, including UV analysis.
- Ability to perform and/or assist with:
- Photostability studies (ICH Q1B)
- Dose dump studies
- Solubility studies
- Polymorphism studies
- Hygroscopy studies supporting regulatory submissions for Drug Substance (DS) and Drug Product (DP)
Regulatory Knowledge
- Basic understanding of applicable ICH guidelines, including but not limited to:
- ICH Q1
- ICH Q2
- ICH Q3
- Understanding of pharmaceutical laboratory compliance requirements and cGMP principles.
Data & Documentation
- Ability to perform basic statistical data analysis.
- Strong laboratory documentation skills with accurate, organized, and legible record keeping.
- Commitment to data integrity and first-time-right execution.
Computer Skills
- Proficiency with Microsoft Office applications, including:
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
Professional Skills
The successful candidate will demonstrate:
- Excellent attention to detail and strong analytical thinking.
- Strong hands-on laboratory skills and the ability to learn new techniques quickly.
- Ability to manage multiple priorities in a fast-paced laboratory environment.
- Strong organizational and time management skills.
- Ability to prioritize work to support manufacturing and project timelines.
- Ability to work independently while also collaborating effectively within cross-functional teams.
- Strong verbal and written communication skills with proficiency in English.
- Ability to perform laboratory testing while standing for extended periods.
- Ability to work safely with chemicals of varying potency while strictly following laboratory safety procedures.
- Ability to perform testing accurately and efficiently to consistently meet customer expectations and production timelines.
Working Environment
- Laboratory-based position requiring extended periods of standing.
- Frequent use of analytical laboratory instruments and equipment.
- Work is performed in accordance with laboratory safety procedures, cGMP requirements, SOPs, and applicable regulatory guidelines.
- Exposure to chemicals of varying potency while following all established safety protocols.
Pay: $25.89 - $28.82 per hour
Work Location: In person
