Job Type

Full-time

Description

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.

Requirements

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 The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.