Sr. Director of Process Chemistry and Drug Substance Manufacturing

BACK

Rain Therapeutics is committed to building a passionate team of core business leaders to implement our vision to identify and execute on the development of novel therapeutic avenues for the treatment of cancer.  The personality of Rain will always be focused on entrepreneurs with autonomy to build their respective teams in a flat organizational structure.

The Sr. Director, Drug Substance Development and Manufacturing to lead process chemistry for all of Rain Therapeutics’ small molecule programs.  This individual will be responsible for the company’s CMC projects in terms of the development of chemical routes and processes of chemical intermediates and drug substance.  This individual will work independently to lead all aspects of process chemistry and drug substance development activities in contract development and manufacturing organizations (CDMOs) from IND submission, clinical supply through Phase 3 and lead successful NDA submissions.  The individual will ensure that the content and quality of regulatory submissions meets the requirements in all markets specified by the regulatory requirements meeting needs of clinical or commercial teams.  Successful technology transfer of processes to commercial manufacturing sites, process validation and support for the R&D responsibilities for pre-approval inspections will be ensured for all projects developed.  The successful candidate will interface with CMC and other Rain departments, ensure adequate staff are in place and may supervise direct reports to support CMC activities.  Develop, coach and lead associates to create high performing teams.  The individual will prepare drug substance related project plans, timelines, budget projections, and assure development activities proceed in alignment with budget to achieve company goals. 

Rain is seeking an enthusiastic, driven, and diligent executive who is a hands-on, detail-oriented individual who will partner well across all business functions and with corporate partners within the rapidly growing enterprise.  The successful candidate will have a stellar work ethic, the flexibility, and organizational skills to manage numerous and sometimes competing responsibilities of varying urgency within a fast-paced environment. 

The Senior Director will report directly to the EVP of Technical Operations. 

Key Requirements:

  • Ph.D. in Organic Chemistry with 10+ years of experience in the Pharmaceutical or Biotech industry with a focus on the small molecule drug product development and manufacturing 
  • A proven track record developing and scaling up small molecules processes from pre-IND through Process Validation using the Quality by Design (QbD) concepts and design of experiments (DoE) 
  • Experience in writing CMC documents for regulatory submissions (IND/NDA/MAA) 
  • Experience leading small molecule process research and manufacturing activities from Phase 1 through Phase 3 projects 
  • Must have NDA preparation experience. 

Position Description

  • Oversee contract development organizations (CDMOs) to lead development and optimization of chemical intermediates and final drug substance processes to support the program from phase I clinical through commercial launch 
  • Review and approve master batch records, executed batch records, manufacturing deviations and investigations in conjunction with quality assurance 
  • Provide on-site technical Man-In-Plant (MIP) support to oversee manufacturing activities  
  • Generate and/or review experimental plans and lead drug substance development activities from route scouting, process optimization, engineering batches, IND-enabling studies, preparation and optimization for registration and commercialization 
  • Analyze and summarize complex data sets, including the use of appropriate statistical tools for the identification of CPPs and CQAs, development of drug substance specifications and shelf-life estimates for intermediates and drug substance  
  • Generate and/or review Process Validation documentation, including Product Validation Master Plans, Statistical Product Sampling Plans, Cleaning Validation Plans, and Process Performance Qualification Protocols in conjunction with engineering, analytical and quality assurance representatives 
  • Prepare technical reports in support of planned regulatory submissions including INDs and NDAs 
  • Write, review, and approve CMC portions of study reports and manufacturing process documentation for compliance with cGMP and other appropriate regulations and guidelines 
  • Assist in supply chain logistics for intermediates and drug substance manufacturing activities 

Preferred Qualifications

  • Experience working with small molecule process development particularly in greater that 50 kg scale chemical development, tech transfer and manufacturing of registration batches 
  • Strong knowledge of applied analytical methodology relating to small molecule in-process controls, drug substance release testing and stability assessment 
  • Ability to identify and mitigate potential regulatory and quality risks for the drug substance manufacture and subsequent resolution of compliance and quality issues; e.g. ICH guidelines, FDA and EMA/CHMP, and other international regulatory requirements  
  • Experience in the selection, evaluation and approval of new CDMOs and suppliers for drug substance development activities, including Tech. Transfer RFPs for commercial suppliers 

Qualities for Success

  • Ability to accurately forecast project budgets and timelines, and manage projects within budget 
  • Ability to effectively work independently in a team environment and demonstrate substantial experience with managing external CDMOs to meet the timelines within the approved budget 
  • Effectively work within the Development department and with cross-functional team leaders to achieve corporate and program goals 
  • Communicate project status and concerns to management and project leadership 
  • Develop, mentor and lead associates across CMC and development functions 
  • Contribute to project plans for delivering the CMC strategy and project objectives 
  • Successful oral and written communication and interpersonal skills 
  • Very strong presentation skills, including preparation of presentation materials in slide format 
  • Ability to travel up to 30% of the time 

Rain Therapeutics is an equal opportunity employer, and we’re proud of our ongoing efforts to foster diversity & inclusion in the workplace. Individuals seeking employment at Rain are considered without regard to race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, physical or mental disability, military or veteran status, or any other characteristic protected by applicable law.