Associate Director, Process Development

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Waltham, MA
$1 - $1
Job Type
Direct Hire
Nov 30, 2018
Job ID
Associate Director, Process Development
Position Summary:
This position will support the development of novel active compounds within the company pipeline.  Specifically, this position will provide strategic leadership for drug substance unit operations, scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation.  Specific areas of focus include reaction engineering, crystallization and process modeling.  The individual is expected to integrate QbD principles, guide experimental design with a focus on process understanding & robustness, interpret data, participate in cross-functional teams, write technical reports and mentor fellow engineers.  The candidate should have strong communication & interpersonal skills, be able to multi-task and have a commitment to continuous learning.  A solid background in chemical engineering is required.
Responsibilities include but are not limited to:
Collaborate within cross-functional teams, specifically with Chemical and Analytical Development to define and execute development strategies that enable successful launch of company products.
Implement scale-up strategies for drug substance synthesis and crystallization unit operations with a focus on process understanding, identification of critical process parameter and process optimization.
Apply reaction engineering and process modeling in development activities.  Identify and deploy new technologies as needed.
Design crystallization processes that deliver solids of desired attributes
Support technology transfer of drug substance unit operations and production at CMO(s)
Integrate Quality Risk Management (QRM) and Quality by Design (QbD) principles into project activities in accordance with ICH Q9 & Q11
Write technical reports and deliver presentations to technical, CMC and broader project groups.
Author & review CMC sections of regulatory filing documents
Mentor fellow engineers
Minimum Education & Experience Requirements:
MS in Chemical Engineering with 15+ years of experience
PhD in Chemical Engineering with 10+ years of experience
Knowledge/Skills Needed:
Excellent written and oral communication.
Experience in introducing, implementing and/or executing new chemical processes in pilot, commercial plants and/or contract manufacturing facilities
Proven ability to apply scientific principles to design, execute and interpret experiments
Experience in drug substance crystallization
Pharmaceutical cGMP manufacturing experience
Statistical design of experiment experience
Team player with good interpersonal skills
Desired but not required
PAT experience & chemometrics (e.g. ReactIR, Raman, FBRM)
Experience with process modeling software (e.g., Matlab, Dynochem)
Experience in working with DEA controlled substances
Quality by Design experience
Personal Attributes Needed:
Motivated self-starter
Positive, adaptable, can-do attitude
Ability to work independently
Ability to travel and work flexible hours as required
Functional ability to work in a pilot plant and commercial facility