Manager/Associate Director, Analytical Development

6/23/21

Princeton, NJ

1285

Manager/Associate Director, Analytical Development

Functions: Analytical Development, QC, scale-up, tech transfer, and validations

The Manager/Associate Director, Analytical Development will serve as a leader and expert in analytical development for various dosage forms (oral solids, semisolids, liquids, and parenteral drug delivery systems); providing strategic and scientific guidance and technical support to the R&D division and other subsidiaries; responsible for the CMC analytical development of primarily small and also potentially large molecules drug products; co-ordinates with other functional groups to achieve the company goals for US and global markets.

Key Responsibilities include but are not limited to:

  • Act as a senior internal analytical leader and expert to support various NDA/ANDA product developments from project initiation to commercialization, provides technical support to facilitate “First-to-File” and “First-to-Market” company’s goals for US and global markets.
  • Provide strategic direction and responsible for the pharmaceutical analytical development work with QbD concept;
  • Support to establish analytical Lab and select proper analytical instruments for various dosage forms.
  • Responsible for safely and effectively developing, establishing, and validating analytical testing methodologies to control raw materials, production intermediates, and final products; ensure all analytical testing activities are in compliance with applicable compendia and FDA/ICH regulatory guidance.
  • Develop SOPs and quality insurance systemic documents for analytical development tasks and quality assurance; ensure all instruments are qualified in good conditions to conduct analytical activities, meet requirements of GMP and appropriate regulatory guidelines.
  • Responsible for multiple analytical project management, setting objectives, and prioritizing activities based on business requirements. Determining budget (equipment, facilities, headcount) requirements to meet organizational goals and balancing resources to ensure that business needs are met.
  • Maintaining an awareness of developing trends and new opportunities to improve operating efficiency and reduce cost.
  • Be responsible for on-time, on-budget delivery of analytical support for drug product development and commercialization.
  • Responsible for routine analytical lab activities well-coordinated, analytical methods qualified and fit for purpose, and the information effectively communicated and documented in a timely manner.
  • Act as a department leader to lead the team, including supervising, coaching, mentoring, developing, and evaluating the professionals.
  • Build a learning environment and foster a culture of scientific excellence through training, influencing, and leading by example in a fast-paced environment.
  • Direct and hands-on in the collection of data, preparation of technical reports for product analytical development reports for regulatory submissions, and deficiency letter response.
  • Serve as primary author or reviewer of CMC sections related to analytical methods and method validation, specifications, and stability in NDAs, ANDA, and other regulatory submissions.
  • Maintain laboratory notebooks documenting work
  • Maintain compliance with GMP, SOPs, and DEA regulations
  • Identify, evaluate, and implement new analytical methods and quality control strategies for new product development, especially for various modified release dosage forms.
  • Identify and address technical and validation gaps in analytical methods and QC testing in preparation.
  • Work with CROs and CMOs to design and implement improvements in analytical methods and Method transfer.
  • Provide scientific guidance on complex manufacturing investigations and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results, and ensure data integrity.
  • Work as an advisor with global PM and other professional individuals in sub-companies of the parent company. Provide the strategical guidance for analytical activities as needs.
  • Interface with key partners include R&D leaders, CMC-Leaders, supply chain platform leaders, Quality Assurance, Global Regulatory Affairs, and Discovery.
  • Act as a partner with internal and external Manufacturing and Quality teams to ensure that appropriate analytical methods are developed, qualified, and put into use for routine QC testing and characterization of drug products, starting materials, and in-process samples.
  • Thorough knowledge of Good Manufacturing Practices. Acts as area management for SOPs, change controls, deviations, and CAPAs (Corrective and preventive action).

Qualifications and Requirement

  • D in Pharmaceutical Chemistry, Analytical Chemistry, Biochemistry or related discipline, at least 10 years relevant experience in ANDA/NDA pharmaceutical product development from “End to End” minimum 3 years of people leadership experience is required,
  • Primary in-depth experience in the pharmaceutical analytical development in NDA and ANDA product development from project initiation to regulatory submissions of various dosage forms including solid oral, soft gels, capsules, transdermal delivery systems, liquids, sublingual films, and injections et al.
  • In-depth theoretical and hands-on experience in various analytical techniques and instrumentations (HPLC, UPLC, HPLC-MS IC, GPC GC, GC-MS, NMR, UV, AAS different types of dissolution units, DSC, FDI, TLC, and HPLC-PDA, etc.) for analytical development.
  • Demonstrated ability and experience with regulatory submission writing and review (NDA and ANDA) and response of FDA deficiency letters.
  • Solid track records in method development, method transfer, and validation for commercial manufacturing.
  • Experience in De-formulation/Reverse Engineering for RLDs to support ANDA product development.
  • Expertise in the development of bio-relevant dissolution method to establish IVIVC or IVIVR and guide formulation development in different stage clinic/BE studies.
  • Excellent verbal and written communication skills, ability to effectively work across levels, functions, and companies
  • Fluent in English
  • Ability to work under pressure to meet deadlines.
  • Self-motivated with the ability to work independently with minimal supervision
  • Working knowledge of Microsoft suite of software products including Excel, Word, and PowerPoint

Knowledge and Skills

  • Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions.
  • Ability to lead successfully within extended, global multinational project teams and handle multiple challenges under pressure.
  • Demonstrated ability for innovation and breaking through.
  • Excellent communications and presentation skills – written and verbal; create and deliver summaries, development reports, and presentations as needs.
  • Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously.
  • Negotiation and strong persuasive abilities, diplomacy, and positive influencing abilities.

Travel Requirements

  • Approximately international 30% travel is required.
  • Domestic and international flights with overnight stays are required.
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