Black Diamond Therapeutics Inc Senior Director, Pharmaceutical Process Development and Manufacturing in Cambridge, Massachusetts
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.
Establish and oversee phase appropriate process development plans for drug substance and product.
Oversee manufacturing of clinical trial material, registration batches, and commercial process validation at contract development and manufacturing organizations (CDMOs).
Technical assessment/selection of CDMOs and assist with contract negotiations.
Create a robust source documents library and co-author corresponding module 3 sections in Investigational New Drug (IND) applications and New Drug Application (NDA).
Represent Technical Operations function on cross-functional product development teams.
Develop Standard Operating Procedures (SOPs) portfolio working closely with Quality Assurance (QA) and Regulatory Affairs (RA) teams.
Grow and develop a team of experienced subject matter experts to advance and commercialize new drugs.
Identify opportunities to capture intellectual property and work closely with legal experts on preparation of patent applications.
A degree in Chemistry or Chemical Engineering, PhD is preferred.
A minimum of 8 years of experience in pharmaceutical industry.
Direct experience in oral solid dose formulation and process control development; including dissolution method, critical quality attributes (CQAs) and their acceptance criteria.
Small molecule drug substance route selection/evaluation scale up and process control development including critical process parameters, critical quality attributes and their acceptance criteria.
Development of phase appropriate specifications and justifications of critical quality attributes for each segment of supply chain, from starting materials to process intermediates to drug substance to formulated drug.
Impurities fate analysis and manufacturing process parameters assessment and overall end-to-end control strategy.
Direct experience leading end-to-end, from regulatory starting materials to drug substance to formulated drug, process development and manufacturing.
Leading and mentoring a team.
Working knowledge of ICH guidelines related to GMP, specifications and their justifications, technology transfers, manufacturing records review and approvals.
In depth knowledge of creation comprehensive source documents libraries and co-authoring corresponding module 3 sections in the CTD, switching formulations during development phase, supporting BABE studies.
The role will be based in our Cambridge office.
This job operates in a professional office environment. This role routinely uses standard office equipment.
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.
Incumbent’s Name: _________
Signature: _________ Date: ___
External Company Name: Black Diamond Therapeutics Inc.
External Company URL: www.blackdiamondtherapeutics.com
Street: 139 Main Street