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Associate Director, Technical Operations

Employer
Black Diamond Therapeutics, Inc.
Location
Cambridge, MA, US
Start date
Jan 16, 2021

View more

Discipline
Manufacturing & Production, Operations
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Genetown

Job Details

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.

Company

Our Vision
Precision Cancer Medicines for Every Genetically-Defined Patient    
 
Company Overview
Black Diamond Therapeutics: A Next-Wave Cancer Precision Medicine Company
 
Black Diamond Therapeutics has pioneered the development of selective medicines for patients with genetically-defined cancers driven by oncogenes activated by allosteric mutations.
 
The cornerstone of our approach derives from evolving trends in cancer clinical medicine. Genome-wide information – now routinely obtained from DNA testing of cancer patients – identifies clusters of uncharacterized genomic alterations. Today, new baskets of un-drugged oncogenic targets exist, leading to the identification of additional cancer patients in need of novel therapies.
 
Using our MAP platform, Black Diamond Therapeutics is pioneering new ways to functionally assess the mutational landscape of individual oncogenes – to discover and validate new targets, and to develop novel approaches to creating highly selective therapeutics.

Company info
Website
Location
One Main Street
Cambridge
MA
02142
United States

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