Senior Scientist/Associate Director, Chemical Engineering

Senior Scientist/Associate Director, Chemical Engineering
Company:

(Confidential)


Senior Scientist/Associate Director, Chemical Engineering

Details of the offer

The Sr. Scientist/Associate Director, Chemical Engineering will establish and maintain engineering services and capabilities to support the development and manufacture of drug substance and drug product for all CMC projects from DC enabling activities to commercial process validation. The incumbent will proactively interact with CMC project leaders, chemists and formulators to identify opportunities engineering principles during process development in order to enhance process understanding, assess scale up risks, and accelerate process development.

Duties and Responsibilities:

Oversee manufacturing related to mostly late phase/commercial drug substance including process design, optimization, scale:up, technology transfer, validation and maintaining the Life:Cycle of the product.
Provide technical leadership within Drug Substance group; Direct and provide technical leadership on Change Controls, investigations, and CAPAs.
Lead critical technical projects relating to the manufacturing of drug substance
Resolve technical issues related to a product line or major technical projects.
Provide direct leadership for day:to:day technical activities commercial drug substance manufacturing :ie, trouble shooting, process changes and improvements, new manufacturing technology implementation etc.
Lead the exercise in the compilation and analysis of production data, such as IPC, release, DoE, and manufacturing process information.
Guide CRO to map polymorph, salt and cocrystal spaces of drug substances for selection of final solid form for development;
Lead and act as the primary interface on technical issues with CMO drug substance manufacturers.
Guide CRO and CMO to design and execute experiments aimed at process optimization and understanding to enable later phase development and process validation;
Maintain internal expertise and equipment to enable identification of potential quantification of scale up parameters and equipment to characterize solid state properties and control drug substance form
Identify, evaluate and acquire new technologies which demonstrably enhance CMCs ability to accelerate process development and deliver material;
Identify and test strategies to reduce manufacturing risks and maintain the life:cycle management.
Lead discussions on the presentation of the data summary to improve manufacturing efficiency.
Author pertinent SOPs and manufacturing process instructions.
Author and review relevant dossier sections related to commercial manufacturing submissions and relevant process knowledge documentations.
Manage small external team to address technical programs and contract manufacturing organizations.
Train and mentor junior scientists and engineers.
Minimum Requirements

PhD in Chemical Engineering + 8:10 years of experience working within a pharma/innovator company.
Work autonomously as often as possible
Has knowledge and implementation strategies for QbD during the development and Life:cycle management of the product.
Proven knowledge and understanding of current ICH guidelines and related industry practices
Experience with NDA writing, what it takes to get filings done and what health agencies are seeking.
Strong attention to detail and the ability to multi:task in fast paced environment
Strong interpersonal skills and the ability to effectively work individually, within a cross:functional team
Strong oral and written communication skills
Strong team player that has a customer service approach and is solution oriented
Positive attitude, energetic and proactive
Ability to travel monthly; up to 20 of time


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