Associate Director/Senior Manager/Manager, Drug Product Deve
Company: Turning Point Therapeutics
Location: San Diego
Posted on: April 8, 2021
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
- 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
- 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
- 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
- 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
- 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
- Experience as the primary author of relevant sections of INDs
- 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
Didn't find what you're looking for? Search again!