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Associate Director/Senior Manager/Manager, Drug Product Deve

Company: Turning Point Therapeutics
Location: San Diego
Posted on: April 8, 2021

Job Description:

Associate Director/Senior Manager/Manager, Drug Product Development and Manufacturing, Small Molecules Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company's lead program, Repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors. Turning Point Therapeutics is driven to develop therapies that mark a turning point for patients in their cancer treatment. We are seeking an-- Associate Director/Senior Manager/Manager, Product Development and Manufacturing. The Associate Director/Senior Manager/Manager for Small Molecule Product Development will report directly to the Senior Director of Small Molecule Product Development and Manufacturing. This individual will be responsible for the company's CMC projects in terms of the development of the formulation and process of the drug products. This individual will work with minimal supervision to support drug product development activities in contract development and manufacturing organizations (CDMOs). RESPONSIBILITIES:

  • Establish the formulation and process development strategies based on the project's Target Product Profile and supporting information.
  • Establish critical raw material attribute control and in-process control strategies.
  • Author/review batch records and protocols.
  • Manage and oversee the formulation and process development, optimization, clinical supply and registration batch manufacturing, packaging, and process validation activities at external contract development and manufacturing organizations (CDMOs) following regulatory guidance and QbD principles in accordance with the cGMP requirements to ensure on-time delivery of the drug product.
  • Oversee the batch manufacturing, intermediate sampling, intermediates, and finished product characterization.
  • Review executed batch records, protocols, and reports related to all GMP operations.
  • Coordinate with Analytical Department for timely testing of new drug products, and the designing and initiating of stability studies on selected batches
  • Work collaboratively with Quality Assurance and Regulatory Affairs to ensure a high-quality level of cGMP and the FDA guidance are followed.
  • Support the compilation of IND/NDA and IMPD/MAA and other regulatory dossiers for global product development
  • Support budget preparation for assigned projects DESIRED SKILLS AND EXPERIENCE:
    • MS degree in Pharmaceutics, Chemical Engineering, Bioengineering, Chemistry, Pharmaceutical Chemistry, or related scientific disciplines with 7+ years of experience in the Pharmaceutical or Biotech industry with the focus on the small molecule drug product development and manufacturing.
    • PhD with 5 + years of experience in the Pharmaceutical or Biotech industry with a focus on small molecule drug product development and manufacturing.
    • A proven track record in developing and scaling up oral solid dosage forms including immediate release, modified, and controlled-release formulations for tablets and capsules from pre-IND through Process Validation using Quality by Design (QbD) concepts and design of experiments (DoE).
    • Extensive experience in product development, clinical supply, and registration batch manufacturing for oral solid dosage product development.
    • Experience in the formulation and process technologies in enabling formulation development to enhance the bioavailability of the BCS class 2 and 4 compounds.
    • Experience in developing age-appropriate pediatric formulations.
    • Experience in the contract manufacturing environment with an in-depth knowledge of unit operations for small molecule drug products including blending, dry/wet granulation, encapsulation, compression, and tablet coating.
    • Experience with aseptic processing, sterile manufacturing is a plus
    • Experience as the primary author of relevant sections of INDs and NDAs.
    • Ability to effectively work independently in a team environment and substantial experience with managing external CDMOs to meet the timelines within the approved budgets.
    • Ability to travel up to 30% of the time. Turning Point Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. Turning Point Therapeutics also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Turning Point Therapeutics is an E-Verify employer.

Keywords: Turning Point Therapeutics, San Diego , Associate Director/Senior Manager/Manager, Drug Product Deve, Executive , San Diego, California

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