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.
• Other duties related to departmental activities may be assigned by the management based on the requirement.

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 of experience.
  • 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).
• Must be able to maneuver at least 40 pounds.
• Must be able to wear a respirator and pass associated respirator tests and/or requirements.
• Must be able to wear all required PPE.
• Vision - ability to see details at close range (within a few feet of the observer).