Sr. Scientist/Principal Scientist, Analytical Development, Tech Ops

Location
Cambridge, MA, US
Posted
Feb 25, 2021
Ref
1076
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 professional to be a technical lead for analytical development of the companies lead asset. This is an exciting technical leadership position within the Technical Operations organization. The Senior Scientist/Principal Scientist will be responsible for the oversight of the development and validation of analytical methods at our CDMO's.

Responsibilities
  • Technical expert for all aspects of drug substance and drug product analytical method development
  • Manage daily activities for all drug substance and drug product CDMOs
  • Monitor work performed by drug substance and drug product CDMOs, including review and approval of reports, raw data, methods and specifications
  • 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 analytical development plans for drug substance and drug product
  • Oversee analytical activities in support of registration batch manufacture and testing and commercial process validation at CDMOs.
  • Identify opportunities to capture intellectual property and work closely with legal experts on preparation of patent applications.

Qualifications

Requirements and experience:
  • A degree in Chemistry or related discipline, MS or PhD is preferred.
  • A minimum of 8 years of experience in pharmaceutical industry.
  • Late-stage development and commercialization experience.
  • Extensive prior experience managing outsourced analytical development and manufacturing required.
  • Ability to travel domestically and international to CDMOs.
  • Experience with analytical method validation, investigations, and specification justifications.
  • Justification and support of critical process parameters, critical quality attributes and their acceptance criteria.
  • Working knowledge of ICH guidelines related to cGMP, technology transfers, manufacturing records review and approvals.
  • Hands on working experience with HPLC, GC, MS, KF, and dissolution at minimum. Experience with solid state techniques also preferred.


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.