Sr Analytical Scientist

Job Description

Sr Analytical Scientist

Position Summary

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 are also required. The incumbent will work 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 core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

• Uses 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 participates 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 12 years of experience or Master’s degree with 8 years of experience, or Ph.D. with 5 years of experience required.
• 2+ years of experience in Pharmaceuticals drug product development under cGMP is required.
• CDMO experience is preferred.

Non-Negotiables

• 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.

Core Leadership Competencies

• Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
• Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
• Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
• Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
• Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
• Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.

Functional Competencies

• Excellent verbal and written communication and documentation skills required.
• Excellent detail orientation and organizational skills required.
• Excellent problem-solving and basic trouble-shooting ability required.
• Excellent knowledge of laboratory equipment and safety required.
• Expert knowledge of Laboratory Documentation is required.
• Ability to develop and implement new methods/processes required.
• Ability to plan and manage multiple tasks for timely achievement of results.
• Working knowledge of cGMP in a pharmaceutical or regulated environment required.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.