Associate Director, Technical Operations

Location
Cambridge, MA, US
Posted
Feb 14, 2021
Ref
1069
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Full time
Overview

Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies. Black Diamond targets undrugged mutations in patients with genetically defined cancers for whom limited treatment options currently exist. Black Diamond is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry. The Company's proprietary technology platform, Mutation-Allostery-Pharmacology, or MAP, platform, is designed to allow Black Diamond to analyze population-level genetic sequencing data to identify oncogenic mutations that promote cancer across tumor types, group these mutations into families and develop a single small molecule therapy in a tumor-agnostic manner that targets a specific family of mutations.

Black Diamond Therapeutics, a clinical stage company, based in Cambridge Massachusetts is looking for an experienced chemistry, manufacturing and controls (CMC) professional to lead pharmaceutical process development and manufacturing. This is an exciting leadership position within the Technical Operations organization. The Senior Director will be responsible for development and execution of phase appropriate/robust CMC strategies.

Responsibilities
  • Subject matter expert for all aspects of drug substance process and controls
  • Manage daily activities for all drug substance CDMOs
  • Monitor work performed by drug substance CDMOs, including review of reports, raw data, master and executed batch records
  • Identify development risks/gaps and lead studies to control/manage them
  • Participate in cross-functional development teams
  • Create a robust source documents library and co-author corresponding module 3 sections in Investigational New Drug (IND) applications and New Drug Application (NDA).
  • Establish and oversee phase appropriate process development plans for drug substance.
  • Oversee manufacturing of registration batches and commercial process validation at CDMOs.
  • Identify opportunities to capture intellectual property and work closely with legal experts on preparation of patent applications.

Qualifications
  • A degree in Chemistry or Chemical Engineering, PhD is preferred
  • A minimum of 8 years of experience in pharmaceutical industry
  • Late-stage development and commercialization experience
  • Statistical DoE experience strongly preferred
  • Extensive prior experience managing outsourced development and manufacturing required
  • Ability to travel domestically and international to CDMOs
  • Small molecule drug substance route selection/evaluation scale up and process control development including critical process parameters, critical quality attributes and their acceptance criteria.
  • Impurities fate analysis and manufacturing process parameters assessment and overall end-to-end control strategy.
  • Working knowledge of ICH guidelines related to cGMP, technology transfers, manufacturing records review and approvals.


Work Location:

The role will be based in our Cambridge office.

Work Environment:

This job operates in a professional office environment. This role routinely uses standard office equipment.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform he essential functions of this job.

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; used hands to fingers, handle, or feel objects, tools, or controls; reach with hands and arms; climb be stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 20 lbs.

Black Diamond Therapeutics is an equal opportunity employer and welcomes and encourages all applications. Diversity and inclusion are important core values and will encourage our creativity and growth as a company. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.