Associate Director, Pharmaceutical Preformulation
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 1693382
Job Description Summary
The Scientific Associate Director, Pharmaceutical Preformulation, will be responsible for leading technical activities related to preformulation and developability assessments of new molecular entities (NCE's), and selecting formulation approaches for early-stage clinical trials (FIH, Phase1-2). The scope includes evaluation of novel or established drug-delivery, formulation, or manufacturing process technologies for overcoming product developability challenges (e.g. solubility, permeability, stability, ADME). He/she will serve as a subject matter expert in areas related to preformulation and drug delivery platforms for small-molecule therapeutics.
- Lead preformulation activities internally and/or at external contract research organizations. Scope includes oral solid dosage forms as well as parenterals.
- Develop standard approaches for preformulation screening of NCE's, and design decision-trees to guide formulation selection decisions. Design effective strategies for developing drug product via conventional methods or drug delivery / process technology approaches.
- Design and implement efficient studies & DOE's to assess product developability risk and demonstrate formulation viability (e.g. screening & optimization of pH, excipient levels, stabilizers).
- Engage with discovery research & pre-clinical teams for biopharmaceutics assessment of NCE's, pharmaceutical candidate optimization activities, and product developability evaluations. Support preclinical team, as needed, in the development of optimal formulations for toxicology studies.
- Engage with API process chemistry and material science teams to ensure drug substance with appropriate physico-chemical properties is advanced for product development. Support material characterization efforts - polymorphic form, mechanical attributes, particle size assessment, physicochemical stability, etc.
- Work cross-functionally with discovery research, clinical, process chemistry, analytical, regulatory, and related teams to achieve program objectives. Author / review study protocols, technical reports, and relevant sections of regulatory documents (e.g. IND, IB, IMPD).
- Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external publications and relevant industry benchmarking metrics to streamline organizational early-to-late stage product development workflows.
What is Required
- Doctorate (Ph.D.) or Masters (M.S.) degree in Pharmaceutics, Pharmaceutical Science, Physical Chemistry, or a related discipline, with 10+ years of relevant industry experience, or BS with 15+ years of relevant experience.
- High competency in preformulation, biopharmaceutics and physicochemical characterization aspects pertinent to small-molecule drug product development.
- Strong scientific understanding of principals related to physical chemistry and pharmaceutics - including pKa, LogP/LogD, solubility (e.g. pH-solubility profile, solubilization, cosolvents), solid-state (e.g. polymorphism, crystal habit, size, surface characteristics, mechanical properties), molecular optimizations (e.g. salt, hydrate, solvate, co-crystals), degradation pathways (e.g. hydrolysis, oxidation, temperature, light).
- Adept in material characterization techniques including x-ray diffractometry, spectroscopy (e.g. FTIR, Raman, NMR, MS, UV/VIS etc.), particle and powder characterization, dynamic vapor sorption, mechanical and thermal analyses.
- In-depth knowledge of proprietary and non-proprietary formulation and process technology approaches for compound enablement (e.g. solubilized formulations, spray dried systems, amorphous drug in polymeric matrices, modified release formulations, permeation enhancers, liposomes, etc.).
- Experience working with drug discovery & pre-clinical teams to assess product developability. Hands-on experience with GastroPlus or related tools is a plus.
- Ability to independently design and implement study plans internal or external CDMO sites. Capability to adapt and improvise based on real time results and findings.
- Exceptional written and verbal communication skills. Ability to lead project teams.
- Experience in authoring and review of regulatory submissions (e.g. IND, IB, IMPD), protocols and related development reports. Strong understanding of ICH, cGMP, worldwide regulatory requirements and industry best practices.
- Ability to travel up to 20% domestically and internationally.
About Mirati Therapeutics
Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.
Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.
We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.
Mirati cultivates an environment where:
- An entrepreneurial attitude is encouraged
- Our people are empowered to speak up, embrace the gray and achieve solutions
- Diverse experiences are an important of part making the best decisions
- We laugh and have fun as a work family
No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati's success.
Learn more at Mirati.com/careers.
Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard 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 information, 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.