Scientist III, Analytical R&D

Job Duties & Responsibilities

• Plan and execute method development, method validation and tech transfer activity for API, excipient, package components and Finish Product.
• Oversees analytical techniques, interpretations of analytical data, problem solving and troubleshooting as required for Analytical R&D activities.
• Prepare and review SOPs, protocols, reports, to support laboratory GMP function in compliance with FDA, ICH and other regulatory guidance.
• Plan, review and implement additional studies (e.g., cleaning validation, Photostability, any in-use studies, Multimedia dissolution, shipping study, etc.).
• Plan and design of experiments toward answering CMC deficiencies responses.
• Perform Investigations (Out of trend, out of specification and laboratory deviations) as per SOP.
• Conforms to all training requirements, including company required and regulatory requirements.
• Manages the AR&D function in the laboratory to ensure cGMP compliance.
• Other duties related to departmental activities may be assigned by the management based on the requirement.
• Provide regular timely reports, interpret analytical data and present results to the manager AR&D and Head as needed.

Management Responsibility

• Reviews staff's performance regularly and develop team members to continually enhance both individual and overall work team performance.
• Take an active role in identifying training needs, challenge and develop both direct and indirect reports in their positions for future opportunities.

Reports to

Manager to Analytical R&D.

Knowledge & Skills

• Knowledge of API, excipient and finish product in generic pharmaceuticals.
• Hands-on experience with drug substance and drug product analytical techniques such as HPLC, GC, KF, MS, dissolution, spectroscopy, and particle size.
• Functional understanding of small molecule analytical development and associated regulatory and quality requirements.
• In-depth understanding of GMPs and applicable CMC, analytical and manufacturing regulatory guidance.
• Excellent verbal and written communication skills.
• Excellent problem solving and interpersonal skills.

Experience & Education

• Master's degree in Analytical Chemistry or Chemistry or related field with 5+ years OR PhD with 3+ years of experience
• Experience small molecule solid oral dosage analytical development is required

Physical Requirements/Working Environment

• Must be able to stand for long periods of time (up to 12-hour shifts), maneuver at least 40 pounds, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE.
• Vision - ability to see details at close range (within a few feet of the observer).

Disclaimer

We believe in fair and transparent pay practices. Actual compensation is determined based on relevant experience, qualifications, skills, and internal equity.