Director, Product Development : 2020-119

Location
San Diego, CA, United States
Posted
Aug 30, 2020
Ref
1473136
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based clinical-stage biotechnology company dedicated to advancing novel therapeutics that extend the lives of patients by directly addressing the genetic and immunological drivers of cancer. Mirati is developing sitravatinib, designed to selectively target a spectrum of tyrosine kinases implicated in both tumor growth and the suppression of immune responses to tumors. Sitravatinib has demonstrated durable responses in lung cancer patients whose cancer has progressed despite treatment with checkpoint inhibitors - an area of significant unmet medical need. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a potentially registration-enabling Phase 3 trial of sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC) that is currently enrolling patients.

Mirati is also developing novel direct inhibitors of KRAS mutations including MRTX849, a potent and selective inhibitor of KRAS G12C. This historically difficult to drug target is present in approximately 14% of NSCLC adenocarcinomas, 4% of colorectal cancer as well as smaller percentages of several other difficult-to-treat cancers. MRTX849 is being evaluated in a Phase 1/2 clinical trial as a treatment for patients with KRAS G12C-positive tumors. Our research on G12C has led to breakthroughs in targeting other KRAS mutations including G12D which drives tumor growth in more patients than G12C and includes pancreatic, colorectal and other types of cancer.

Our mission is to discover, design, and deliver breakthrough therapies to transform the lives of cancer patients and their loved ones. We have built a culture fueled by accountability, urgency, collaboration and open-mindedness, and have established ourselves as an innovator within our industry. As we grow, we are looking to build diverse teams, with skilled individuals that are passionate about their work.

Why join us? The Director, Product Development will be responsible for design and development of small molecule solid oral drug products for clinical studies and commercialization. He/she will provide technical expertise towards formulation and process development, scale-up and tech-transfer activities conducted in-house and at external contract development & manufacturing organizations (CDMO's). He/she will work effectively with cross-functional groups, including analytical development, process chemistry, clinical, quality and regulatory, to ensure that drug products are developed and manufactured in compliance with all applicable regulations and corporate procedures (GLP, GMP, ICH). He/she will serve as a subject matter expert in activities related to product development, and author / review relevant sections of the CMC regulatory dossiers.

Your Responsibilities:
  • Design and develop optimal formulations, and robust, scalable & cost-effective processes for the manufacture of DPs for clinical studies and commercialization. Design and implement efficient DOE's to support formulation and process robustness.
  • Engage with API process chemistry group to ensure drug substance with optimal physico-chemical properties is advanced towards commercialization. Support material characterization efforts - solid state form, mechanical attributes, particle size assessment, physicochemical stability, etc.
  • Support preclinical team in the production of optimal formulations and preparation procedures for toxicology and DMPK studies. Provide technical inputs to cross-functions towards clinical dosage form bridging strategies and to manage potential scale-up and post-approval changes.
  • Support screening and selection of CRO's & CDMO's for drug product, and lead R&D activities for product development and manufacturing at internal and external sites. Work cross functionally with analytical, regulatory, clinical and related teams to achieve program objectives.
  • Author / review manufacturing batch records and study protocols. Author / coordinate preparation of high-quality technical reports and integrated project summaries.
  • Author/ review CMC regulatory documentation for IND, NDA and IMPD filings, covering all phases of clinical development in both the US and ex-US markets. Assist during quality events (QEs) or failure investigations and implementation of CAPAs at contractor sites.
  • Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external publications and relevant industry benchmarking information to efficiently design product development strategies.
  • Represent product development function and present work at intra/inter departmental meetings.

What is Required:
  • Doctorate (Ph.D.) or Masters (M.S.) degree in Pharmaceutics, Pharmaceutical Science, Chemical Engineering, or related scientific field, with 10+ years of related industry experience, or BS with 20+ years of relevant experience.
  • Highly skilled in formulation design and process development of immediate & modified release oral solid dosage forms. Expert in pharmaceutical manufacturing processes including dry/wet granulation, compression, coating and packaging.
  • Strong understanding of scientific principals related to pharmaceutics, material science and physical chemistry. Experience in parenteral dosage form development is a plus.
  • Ability to independently design and implement study plans & DOE's related to drug product & process development, conduct risk assessments and delineate risk mitigation strategies (FMEA).
  • Experience in technology transfer of drug product to clinical & commercial drug manufacturing sites, including management of activities at CDMO's.
  • Capability to adapt and improvise based on real time results and findings.
  • Exceptional written and verbal communication skills. Ability to lead project teams.
  • Extensive experience in authoring regulatory submissions (IND, NDA, MAA), development reports, batch records, protocols and associated reports (PDR, QbD, Validation).
  • Strong understanding of ICH, cGMP, worldwide regulatory requirements and current industry best practices.
  • Ability to travel up to 25% domestically and internationally.

Mirati's policy is to provide equal employment opportunities to all applicants and employees without regards to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic informations, or any other basis protected by applicable law.

Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.