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Associate Director, Process Development

Employer
Rain Oncology
Location
Newark, CA
Start date
Jun 17, 2022

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Job Details

Associate Director, Process Development

   Are you ready to join a growing, innovative, precision oncology powerhouse? Rain Therapeutics is committed to building a passionate core team of scientific, clinical, regulatory, and business leaders to bring new targeted therapies for cancer patients struggling with limited treatment options. Our focus has been and will continue to be new oncology therapeutics based on targeting the biological drivers of the cancer, regardless of tumor type.

The Associate Director, Process Development will be part of process chemistry and drug substance development team for all of Rain Therapeutics' small molecule programs, including the development of chemical routes and the optimization of chemical processes. The successful candidate will direct and oversee contract development and manufacturing organizations (CDMOs) as well as lead process development efforts in preparation for successful process validation and NDA/MAA submissions as well as commercial launch. This position reports to the head of Chemical Development. 

Key Performance Objectives:


• Lead and manage CDMO activities for late-stage development (e.g., tech transfer, scale-up/process development/optimization and from process validation through commercialization)

• Lead process development studies according to the principals of Quality by Design (QbD), specification justification studies to establish limits, process characterization studies such as one-variable-at-time (OVAT) and DOE studies to identify proven acceptable ranges (PARS) of critical process parameters (CPP), including identification of edge-of-failure (EoF), characterization of APIs to identify critical quality attributes (CQA).

• Direct the CROs/CMOs in terms of chemical development strategies during clinical development and design of registration strategies for commercial supply chain(s), review, and approval of release testing data, as well as stability data.

• Review quality control testing and certification to guarantee that batches meet specifications and are in compliance with cGMP; and document and institutionalize all development activities as source materials for regulatory filings.

• Author and review validation related documents and process development reports

• Actively contribute to writing key CMC sections of regulatory documents IND/IMPD/NDA/MAA.

• Drive continuous improvements in the drug substance development process through technological innovation and problem solving.

• Serve as subject matter expert in drug substances and help drive best practices and technical advancements.

• Deliver progress reports and presentation to ensure management awareness and engagement of the status, progress, and future program and functional needs.

• Design chemical development strategy that is phase-appropriate and well positioned for accelerated development, and design and execution of validation master plan to support commercialization.

Preferred Education and Experience:


• Ph.D., MS, or BS in Organic Chemistry, Chemical Engineering (or related discipline) with at least 8+ years of progressively broad experience in the Pharmaceutical or Biotech industry with demonstrated track record of successfully validating API required.

• Demonstrated expert knowledge in regulatory/cGMP requirements (for both the US and EU Directive) as applied for CMC development strategy and demonstrated success in the application of QbD principles

• Solid ability to effectively communicate to functional groups across all levels of the organization and competent authorities.

• Demonstrated success in shepherding late phase drug substance characterization to validation, pre-approval inspection and commercial manufacturing.

• Extensive experience in managing contract manufacturing organizations in North America, Europe and Asia.

• Strong leadership, interpersonal communication, collaboration and problem-solving skills (especially process chemistry related) along with strengths in delivering results on firm deadlines in support of development programs.

• Organizational and planning skills required to determine appropriate resources for resolution of problems.

• Ability to travel domestically and internationally up 25% of the time required.

• Ability and willingness to be fully vaccinated against Covid-19 and similar diseases

Company

Rain BRINGS LIFE

The beauty and complexity of life is near limitless, with the world around us based on the cyclicality of the seasons and marking a shift in the progression of life. When the rains come, they bring sustenance to the life all around us, from which there is renewal and replenishment.  Water and the rain help reinvigorate life and strengthen us for the path forward.  

Rain Oncology was named to symbolize the renewal, sustenance and replenishment that reinvigorates life afforded by the rains.  In the same way, we hope to provide a renewal and reinvigoration for patients debilitated by cancer.  Rain Oncology hopes to leverage industry-leading insight into the mechanisms triggering cancer to find precision therapeutic strategies that may offer patients an improved chance of getting their lives back.

Rain Oncology was founded in 2017 as a precision oncology company leveraging a deep scientific knowledge of drug mechanism and designing clinical trials with the most appropriate patient population most likely to benefit from treatment. Rain is focused on a few critical objectives: (1) strive to greatly enhance probabilities of therapeutic success for patients by focusing on genetic biomarkers that may predict optimal therapeutic strategies, and (2) pursue biomarker-based trial designs of limited size that enable rapid decision-making and redirecting of strategy when needed, minimizing expense and preserving capital resources.

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Our team is the heart and soul of Rain Oncology.  Not only is a dynamic, energetic, entrepreneurial team essential to drug development success at Rain, it's also paramount to the type of culture where people feel rewarded every day.  

Rain Oncology is looking for team members that don't want to work in a conventional corporate environment.  We are looking for professionals who believe, at their core, that a small company that empowers its people can move much more quickly and effectively than large organizations with significantly more financial firepower.  Rain Oncology is looking for experts who want more control in galvanizing 21st-century science for patients.

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Stock Symbol: RAIN

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Company info
Website
Phone
510-953-5559
Location
8000 Jarvis Ave Suite 204
Newark
CA
94560
United States

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