The Sr. Dir., Drug Product Development and Manufacturing will lead drug product activities 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 formulations and processes of the drug products. This individual will work independently to lead all aspects of drug product 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 products 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 product 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 Senior Director will report directly to the Senior Director.
- BS/MS degree in Chemistry, Pharmaceutics, Chemical Engineering, Pharmaceutical Chemistry, or related scientific disciplines with 15+ years of experience in the Pharmaceutical or Biotech industry with the focus on the small molecule drug product development and manufacturing
- Ph.D. with 10+ years of experience in the Pharmaceutical or Biotech industry with a focus on the small molecule drug product development and manufacturing
- Experience in writing CMC documents for regulatory submissions (IND/NDA/MAA)
- A proven track record in developing and scaling up oral solid dosage forms including immediate, modified, and controlled-release formulations for tablets and capsules from pre-IND through Process Validation using the Quality by Design (QbD) concepts and design of experiments (DoE)
- Must have NDA preparation experience
- Oversee contract development organizations (CDMOs) to lead development and optimization of drug product formulations 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 product development activities from research formulations, 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 product specifications and shelf-life estimates for drug product formulations.
- 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 drug product manufacturing activities.
- Extensive experience in product development, clinical supply, and registration batch manufacturing for oral solid dosage and aseptic liquid or lyophilized infusion product development
- Experience in the contract manufacturing environment with an in-depth knowledge of unit operations for the small molecule drug products including blending, granulation, encapsulation, compression, and tablet coating
- Experience in sterile product development, including formulation, filling, lyophilization and associated container closure systems
- Experience in formulation and process technologies by utilizing the enabling formulation approaches to enhance the bioavailability of the BCS class 2 compounds