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Associate Director / Director

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Associate Director / Director, Analytical Development Company: Black Diamond Therapeutics Inc

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Black Diamond Therapeutics Inc Associate Director / Director,Analytical Development in Cambridge , Massachusetts Black DiamondTherapeutics is a precision oncology medicine company pioneeringthe discovery and development of small molecule, tumor-agnostictherapies. Black Diamond targets undrugged mutations in patientswith genetically defined cancers for whom limited treatment optionscurrently exist. Black Diamond is built upon a deep understandingof cancer genetics, protein structure and function, and medicinalchemistry. The Company’s proprietary technology platform,Mutation-Allostery-Pharmacology, or MAP, platform, is designed toallow Black Diamond to analyze population-level genetic sequencingdata to identify oncogenic mutations that promote cancer acrosstumor types, group these mutations into families and develop asingle small molecule therapy in a tumor-agnostic manner thattargets a specific family of mutations.

The Development team at Black Diamond Therapeutics is lookingfor a dynamic and self-motivated Associate Director / Director,Analytical Development to apply her/his expertise and knowledge toour drug development programs. Based in our office in Cambridge,MA, the right candidate will work closely with our CDMOs, leadanalytical activities for both drug substance and drug product frompre-clinical through to NDA and commercialization.

Responsibilities:

Manage day-to-day analytical activities including timeline,budget management and objective setting

As the technical expert, design detailed and phase appropriatework plans and execute the plans through partnership with ourCDMOs. Guide CDMOs to conduct development, validation and testing.Technical oversight all the activities at CDMOs

Lead phase appropriate analytical method development andvalidation from preclinical through to NDA filing in compliancewith ICH and related guidances

Lead phase appropriate stability studies for starting materials,intermediates, drug substance and drug product from preclinicalthrough to NDA filing in compliance with ICH and related guidances.Stability assessment including OOC and OOT to establish shelflife.

Lead development activities such as stability studies,compatibility studies, establishment of phase-appropriatespecifications and control strategies for starting materials,intermediates, drug substance, excipients and drug product

Lead the characterization of reference standards and analyticalreferences, and manage the inventory

Review and approve analytical results, protocols and reports

Assist QC/QA with laboratory investigations, deviationinvestigation and review of investigation reports

Author and review analytical development/validation reports andanalytical sections in regulatory submissions (IND/IMPD,information requests, amendments, briefing books, NDA/MAA etc.)

Participate in the establishment of CQAs, specifications, IPCsfor intermediates, drug substance and drug product

Manage transferring analytical methods across CROs/CDMOs at allstages of drug development

Lead the assessment and approval of GMP method change controls,investigation of OOS and OOT test results, and follow-up ofcorrective actions

Review CMO/CRO SOPs, qualification protocols and validationprotocols

Collaborate effectively with the Project Management, Discovery,Quality, and Regulatory groups to meet program goals

Qualifications:

Requires an MS or PhD in analytical chemistry, organic chemistryor related field with 10+ years experience in analyticaldevelopment in the pharmaceutical industry

Small molecule API and solid oral dose form experience isrequired

Demonstrate leadership skills, planning and organizationalcapabilities. Effectively implement work planscross-functionally

Proven ability to manage projects and work with cross-functionalteams comprised of internal groups and external CDMOs

Knowledge of analytical testing concepts and cGMPs includinglaboratory controls and good documentation practices acrossdevelopment stages from pre-IND to NDA

Ability to work flexibly to accommodate program priorities,international activities, and travel as needed

Demonstrated ability to build and maintain positive andcollaborative relationships with management, peers and CDMOs

Strong organizational skills in order to maintain a high levelof productivity, innovation, and priority-setting in order tocomplete assignments on-time and on-budget.

Excellent oral and written communication skills

Ability to work independently, or under minimal supervision tohandle workflow in a multi-tasking environment

Experience in CMC operations and project management considered aplus

To Apply:

Please forward applications via email only tocareers@bdtherapeutics.com including a cover letter and resume. Inthe e-mail subject line, please indicate the position titleScientist/Senior/Principal Scientist, DMPK.

Black Diamond Therapeutics is an equal opportunity employer andwelcomes and encourages all applications. Diversity and inclusionare important core values and will encourage our creativity andgrowth as a company.

External Company Name: Black Diamond Therapeutics Inc.

External Company URL: www.blackdiamondtherapeutics.com

USA Cares exists to help bear the burdens of service byproviding post-9/11 military families with financial and advocacysupport in their time of need.

USA Cares is a national 501(c)(3) non-profit, charitableorganization based in Kentucky and registered with the IRS.

Keywords: Black Diamond Therapeutics Inc, Cambridge , Associate Director / Director, Analytical Development, Other , Cambridge, Massachusetts

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