A Senior Scientist is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. A Sr. Scientist will routinely lead method development/method validation projects. HPLC and/or GC based methodologies are commonly employed in the described testing. Other key methodologies applied include: dissolution, titrations, UV, AA, IR. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company). Detailed understanding of the theoretical basis of the methods/experiments along with ability to troubleshoot equipment is also required. Works on extremely complex problems in which analysis of situations or data requires an evaluation of tangible and intangible variables. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.
- Advanced skills in multiple techniques, to include: assays (potencies, related substances), dissolution/drug release, residual solvents, elemental impurities, moisture content, identification, and various other wet chemistry based measurements.
- Develops and validates methods, test procedures, protocols and reports.
- Understands the theoretical basis of methods/experiments.
- Maintains strong knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
- Analyzes information for technical correctness and accuracy.
- Evaluates and interprets data.
- Achieves results by solving problems of a diverse scope.
- Interacts with clients and participate in regulatory agency and/or client audits.
- Leads investigations and root cause analysis.
- Drives initiatives outside of standard work function.
- Maintains a safe, clean, and organized work environment free of safety hazards.
- Safely handles potent compounds.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Education and Experience
- Bachelor’s degree in Chemistry with 10+ years of experience or Master’s degree with 8+ year of experience, or Ph.D. with 5-7 years of experience required.
- 2+ years of experience in Pharmaceuticals drug product development under cGMP is required.
- CDMO experience is preferred.
- Consistently demonstrates honesty and integrity through personal example.
- Follows all safety policies and leads by example a safety first culture.
- Produces high quality work product with a focus on first time right.
- Complies with the company code of conduct and policies and regulatory standards.