Analytical Principal Scientist Contractor
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.
We are looking for an experienced professional to be technical support for analytical development of the company’s lead asset and will be responsible for the oversight of the development and validation of analytical methods.Responsibilities
- Review drug substance and drug product Batch release data and work with vendors to address comments on a rolling basis.
- Coordinate review with BD Quality assurance to achieve batch release on time.
- Review drug substance and drug product stability data for GMP and R&D batches, gather data in spreadsheets, trend data, write summary reports.
- Review stability protocols for drug substance and drug product.
- Review analytical validation protocols and reports for starting materials, intermediates, drug substance and drug product.
- Review analytical methods and release data for starting materials, intermediates, drug substance and drug product.
- Establish product shelf-life and support shelf-life extensions, as appropriate.
- Review product excursion data from depot/clinical sites and issue excursion memos on a rolling basis.
- Maintain a robust source document library and co-author corresponding module 3 sections in Investigational New Drug (IND) applications and New Drug Application (NDA).
- Must have a Bachelor of Science Degree; Masters or PhD preferred
- Minimum of 6-8 years’ experience in the pharmaceutical/biotech industry
- Hands on working experience with HPLC, GC, MS, KF, and dissolution at minimum.
Currently, the position is remote, however, once the company returns to the office, this person will be expected to come on site.
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.