Director / Sr Director, CMC Operations, Pharmaceutical Development

Decibel Therapeutics

Boston, MA, US
  • Job Type: Full-Time
  • Function: Life Sciences R&D/Engineering
  • Post Date: 06/15/2021
  • Website: decibeltx.com
  • Company Address: 215 First St, Cambridge, MA, 02142

About Decibel Therapeutics

Decibel Therapeutics, a clinical-stage biotechnology company, has established the world’s first comprehensive drug discovery, development, and translational research platform for hearing and balance disorders. Decibel’s lead therapeutic candidates, DB-020 and DB-041, are designed to prevent hearing loss resulting from cisplatin and aminoglycoside antibiotics, respectively. Decibel is also advancing a portfolio of discovery-stage programs aimed at restoring hearing and balance function to further our vision of a world in which the benefits and joys of hearing are available to all. Decibel is headquartered in Boston, Mass.

Job Description

Location: Boston, MA
Department: Discovery
Description:

Position Overview & Responsibilities

Decibel Therapeutics is seeking a member of the Pharmaceutical Development group to be responsible for leading and managing CMC operations and activities in support of Decibel’s clinical development programs as well as establishing CMC strategy and practices for the organization. The candidate must be a strong leader experienced in integrated approaches to AAV Gene Therapy CMC development, working with cross-functional project teams in a matrix organization, have knowledge of global AAV CMC development strategies, experience with all stages of clinical development and extensive vendor management experience.

 

Responsibilities include:

•    Maintain current, global knowledge of phase-appropriate AAV CMC and combination device best practices

•    Partner with process development on:

  1. ­   Integrated CMC development 
  2. ­   AAV CMC development strategy and its integration into the overall strategic product development plans
  3. ­   AAV CMC leadership and integrated CMC project management
  4. ­   CMC activities for all phases of development, including pre-IND through to validation and NDA
  5. ­   Vendor selection, management, and technology transfer

•    Work collaboratively with process and analytical development, regulatory, quality, non-clinical safety, and clinical to establish phase-specific CMC practices for Decibel’s development programs

•    Device and device qualification

•    Drug and finished product manufacturing, clinical supply, and distribution

•    Management of FP and clinical supply CMOs

•    CMC representation on project teams

Experience and skills required:

•      Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences or related with 10+ years of experience in CMC/pharmaceutical development

•      AAV CMC practices and requirements for injectable drug product, finished product, label pack and distribution, including delivery device qualification 

•      Stages of global AAV CMC development (IND/CTA-NDA/MAA) across multiple products/programs

•      Knowledge of phase-specific, global AAV CMC and device combination practices and regulatory requirements

•      Regulatory agency CMC interactions and submissions

•      Vendor management and technology transfer

•      Demonstration of strong leadership and management abilities

•      Excellent computer, documentation and organizational skills

•      Strong problem-solving skills and work ethic, good documentation and communication skills, as well as an attention to detail

•      Ability to work in a cross-functional team environment is a must

•      Title will be commensurate based on experience

 

Decibel Therapeutics, Inc. is proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce.  We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability or any other status protected under federal, state or local law.  All employment is decided on the basis of qualifications, merit and business need.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.