Manager, Analytical R&D

Job Duties & Responsibilities

Manage day to day laboratory operations and supervise group’s daily activities.
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 and Manage In-process release testing for exhibit batches and coordinate with Quality Control for stability testing.
Plan, review and implement additional studies (e.g., cleaning validation, extractable/leachable, Elemental impurity, residual solvent, Nitrosamine, Photostability, any in-use studies, Multimedia dissolution, shipping study, etc.).
Use project management techniques to identify, develop and maintain planning tools (e.g., spreadsheets, MS Project) in support of AR&D projects activities.
Effectively Communicate with outside vendor/contract laboratory and plan and execute the outside laboratory testing.
Work closely with Product development team to manage and coordinate analytical activities on development samples.
Plan and design of experiments toward answering CMC deficiencies responses.
Work in collaboration with other departments, (e.g., Product development, Regulatory affairs, Quality Assurance, Quality Control, Contract laboratories, Supply chain etc.) to support timely new product development/submission of new ANDAs and commercial launches.
Performs appropriate review of pharmaceutical product development report (PDR), Quality overall summary (QOS) and other necessary documents to support regulatory filing of ANDA's.
Investigate Out of trend, out of specification and laboratory deviations, propose and implement corrective and preventive actions (CAPA).
Conforms to all training requirements, including company required and regulatory requirements
Manages the AR&D function in the laboratory to ensure cGMP compliance.

Management Responsibility

Provide regular timely reports, interpret analytical data and present results to the department head and R&D Head as needed.
Reviews staff's performance regularly and develop team members to continually enhance both individual and overall work team performance.
Reports to Director, 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: Bachelor's degree in Analytical Chemistry or Chemistry or related field with 10+ years or MS/PhD with 7+ years of GMP and GLP-related pharmaceutical industry experience in small molecule solid oral formulation analytical development.

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).

Schedule

Full-time

Pay

$100,000 - $130,000/Yearly