This site uses cookies. To find out more, see our Cookies Policy

Associate Director, Process Development in Lexington, MA at APEX Systems

Date Posted: 5/17/2019

Job Snapshot

Job Description

Job #:  898881
Associate Director, Process Development, 898881
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.
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us at 877-787-2821.