Education: Bachelor's degree in Analytical Chemistry, Pharmaceutics, or a related field. A Master's degree is preferred.
Role Overview:
The Scientist will be responsible for conducting routine analysis of finished pharmaceutical products and raw materials, as well as testing stability samples under various ICH conditions. This includes performing assays, dissolution, hardness tests, water content analysis, and content/blend uniformity. The Scientist will use wet chemistry techniques and follow compendial monographs for analytical testing of excipients and active pharmaceutical ingredients (APIs). The role requires proficiency in laboratory instrumentation like HPLC, dissolution, Karl Fischer, and pH meters.
The Scientist will report to the Quality Control & Analytical Product Development Manager, Senior Scientist, or Principal Scientist and contribute to ongoing pharmaceutical projects.
Top 3 Requirements:
Experience: Minimum of 3 years of relevant industry experience, particularly in pharmaceutical product development and quality control.
Technical Skills: Expertise in HPLC, GC, UPLC, FTIR, UV, Karl Fischer, and other wet chemistry methods.
Regulatory Knowledge: Experience with GMP and ICH regulations.
Key Responsibilities:
Testing & Analysis: Perform routine tests on finished products and raw materials, including assays, content uniformity, blend uniformity, moisture content, related substances, dissolution, and stability testing under ICH conditions.
Instrument Operation: Utilize laboratory instruments such as HPLC, GC, UPLC, Karl Fischer, Dissolution, and pH meters for various tests.
Data Reporting & Review: Follow approved procedures to test and report data, ensuring accuracy and compliance with regulatory standards. Conduct data review and trending, and assist with laboratory investigations as necessary.
Regulatory Compliance: Adhere to regulatory guidelines, SOPs, cGMPs, and laboratory procedures during all activities.
Collaboration & Support: Assist other scientists in completing projects on time and support lab personnel as required.
Quality Control: Perform stability testing, QC release testing, and data review for finished products.
Controlled Substances: Handle DEA-controlled substances and comply with relevant regulations.
Continuous Improvement: Participate in Opex activities, SOP revisions, and ensure all work aligns with current best practices.
Laboratory Investigations: Use TrackWise or other systems for conducting laboratory investigations in accordance with SOPs.
Qualifications:
Education: Bachelor's degree in Analytical Chemistry, Pharmaceutics, or a related field. A Master's degree is preferred.
Experience: Minimum of 3 years of relevant industry experience, particularly in pharmaceutical product development and quality control.
Technical Skills: Expertise in HPLC, GC, UPLC, FTIR, UV, Karl Fischer, and other wet chemistry methods.
Regulatory Knowledge: Experience with GMP and ICH regulations.
Communication: Strong written and verbal communication skills.
Adaptability: Ability to work effectively in a fast-paced environment with tight deadlines.
Problem-Solving: Strong analytical and reasoning abilities with the capacity to interpret and apply instructions in various forms.
Physical Requirements: Ability to sit, stand, and walk regularly. Occasional lifting of up to 40 pounds. Frequent use of a computer screen and reading of written documents.
Additional Skills & Competencies:
Documentation & Compliance: Maintain high-quality lab documentation in accordance with applicable regulatory guidance and site SOPs.
Leadership: Ability to lead by example, guide team members, and contribute to staff development.
Teamwork: Collaborative approach to solving issues and ensuring timely project completion.
Strategy & Efficiency: Strong organizational skills and the ability to prioritize and manage multiple tasks effectively.
Training & Development: Assess training needs and contribute to the development of team members.
Physical Demands:
Occasional lifting up to 40 pounds
Regular sitting, standing, and walking
Frequent use of computer screens and written documents