Director Analytical Chemistry – NCE Development

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 Director, Analytical Chemistry position will assume a leadership, as well as a hands-on role in internal and external CMC activities for all of Rain Therapeutics’ small molecule programs.  This individual will be responsible for the company’s CMC projects in terms of providing strategic and technical leadership for new analytical method development, method transfer, method validation, and raw data/protocol/report review and approval.  Acting as a subject matter expert, the Dir. of Analytic Chemistry will lead all aspects of Quality Control, specification limit setting and justification.  This individual will work closely with the CMC and regulatory team to support development of analytical methods, IPCs and specifications for drug substance and drug product processes, including method development in support of registration batches, ICH stability and commercial launch.  They will lead and oversee planning and execution of development, tech transfer, testing and validation with external development and manufacturing partners.  The successful candidate will have a depth of leadership experience supporting multiple small molecule programs through late stage development, interactions with regulatory authorities and successful NDA drafting and submissions.  The successful candidate will interface with CMC and other Rain departments, ensure adequate staff are in place and may supervise direct reports to support analytical and QC activities.  Develop, coach and lead associates to create high performing teams.  The individual will prepare analytical development 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 candidate 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 Director will report directly to the EVP of Technical Operations. 

Key Requirements:

  • Degree in analytical chemistry or other related scientific discipline (graduate degree in analytical chemistry or organic chemistry highly preferred)
  • PhD and 10 years or more experience in roles of increasing seniority in analytical chemistry and QC functions with leadership in late stage development and launch of small molecule drugs.  (BS/MS 12+ years’ experience)
  • Small molecule development experience required
  • Experience in analytical method development/validation through NDA is required
  • Experience in writing CMC documents for regulatory submissions (IND/NDA/MAA)
  • A proven track record in developing and supporting small molecule programs, oncology programs preferred, from pre-IND through Phase 3 and launch
  • Extensive expertise in the development of robust, fit-for-purpose analytical control strategies, analytical method development, validation and transfer, and analytical understanding for drug substance and drug product process development, scale up and technology transfer
  • Strong technical background in analytical chemistry is required; including direct experience with analytical technologies used routinely in the pharmaceutical industry (UPLC/HPLC, GC, IC, ICP, UV-Vis, Karl Fischer, Mass Spectrometry, NMR, X-ray diffraction, and others)
  • Extensive experience in drug substance and drug product process development, scale-up from pilot plants to commercial facilities and analytical method transfers from R&D to commercial QC testing laboratories
  • Understanding of cGMP, cGLP and regulatory requirements for clinical development and marketing authorizations in the U.S., EU and Asia

Position Description

  • Lead internal and partner groups to develop NCE pharmaceutical candidates (RSM to API to DP) from early development through NDA approval and launch
  • As the technical expert, design detailed and phase appropriate work plans and execute the plans through partnership with CDMOs for RSMs, DS and DP. Guide CDMOs to conduct development, validation and testing.  Technical oversight all the activities at CDMOs 
  • Review and edit key regulatory documents, technical reports and analytical method packages to drive high quality regulatory submissions and source reports and ensure fit-for-purpose knowledge management
  • Lead development activities such as fate of impurities, comparability studies, establishment of clinical phase-appropriate specifications and control strategies for starting materials, drug substance, excipients, and drug product
  • Design phase appropriate stability studies for starting materials, intermediates, drug substance and drug product from preclinical through to NDA filing in compliance with ICH and related guidance
  • Stability assessment including stress studies, trending, OOC and OOT to establish shelf life
  • Participate in the establishment of CQAs, specifications, IPCs for intermediates, drug substance and drug product  
  • Design and implement analytical program to support RSM establishment in US and EU
  • Review CMO/CTL SOPs, qualification protocols and validation protocols 
  • Assist QC/QA with laboratory investigations, deviation investigation and review of investigation reports 
  • Development of Module 3 analytical content in collaboration with Regulatory Affairs, serving as the analytical lead for associated regulatory interactions
  • Author, review, and approve Requests for Proposals (RFPs), technical reports, test procedures, validation protocols and reports
  • Develop accurate budget, timelines and staff projections to support multidisciplinary team goals

Qualities for Success

  • Excellent organizational skills with the ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities while maintaining attention to detail
  • 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
  • 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.