Associate Director, Process Development in Lexington, MA at Apex Life Sciences

Date Posted: 11/15/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Lexington, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/15/2018
  • Job ID:
    898881

Job Description


Job Scope & Purpose:

Our Greater Boston area client with a clinical pipeline in inhaled therapeutics is seeking an exceptional and motivated Process Development Engineer to lead a team overseeing drug product process development and scale-up for multiple programs through clinical development.  The ideal candidate will have ample industry experience leading programs through various stages of clinical development, and can lead programs to registration and commercialization. 

Primary Job Requirements:

  • BS/MS/PhD in Chemical Engineering or Material Sciences with minimum of 10 years industry experience

  • Experience in developing multi-step drug product manufacturing processes, including preferred expertise in particulate-based technologies

  • Previous experience from phase 1 through phase 3, with commercialization experience preferred but not required

  • Small molecule drug product development experience within any dosage form (solid oral, liquid, inhaled, lyophilized, injectable, etc.), with preference given to experience with solid-based dosage forms

  • Previous experience managing and mentoring junior engineers and scientists required

  • Excellent communication and written skills required due to the collaborative nature of the position

  • Good knowledge of interplay between formulation and process, solid state chemistry, stability, and material science

  • Working familiarity with regulatory guidances pertaining to pharmaceutical development and risk management (ICH Q8, Q9)

  • Ability to travel between 10-20%, both domestically and internationally

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

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Code:TechOps





898881