Sr Manager Analytical Development 2020-118

Location
San Diego, CA, United States
Posted
Aug 19, 2020
Ref
1461818
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.

Who are we: 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 Sr Manager, Analytical Development will be responsible for the development of analytical methodology and characterization activities in support of new drug substance and new drug product development and manufacturing. He/she will provide guidance and support to internal and external groups to ensure that products are manufactured in compliance with all applicable regulations and corporate policies and procedures (GLP and cGMP). He/she will provide analytical support for API and drug product manufacture in support of preclinical, clinical, registrational, and commercial batches.

Your Responsibilities:
  • Work with multi-functional project teams to execute phase-appropriate analytical strategies including analytical method development and qualification/validation, establishment of specifications, reference standard and product characterization.
  • Manage activities related to analytical method development, optimization, troubleshooting, qualification, and validation activities for starting materials, process intermediates, drug substances, and drug products internally and across CMOs.
  • Provide support in identifying y and recommending analytical methodologies to support chemical development, formulation development, QC and stability testing.
  • Manage when appropriate analytical activities at CROs/CMOs including method development and qualification/validation, characterization testing. Review of analytical raw data packages. Ensure studies are conducted in compliance with GLP and cGMP regulations, as applicable.
  • Provide technical support in resolving technical issues, reviewing deviation events and failure investigations at contractor sites in coordination with internal and external. quality control, quality assurance, and regulatory groups, as appropriate. Provide technical input for OOS and OOT investigations.
  • Author/review technical documents outlining analytical activities including method validation, management of reference standard program and impurities characterization, stability, etc.
  • Provide support in authoring or review of analytical sections of chemistry, manufacturing and control (CMC) sections of regulatory submissions.
  • Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development.
  • Represent analytical function in CMC teams and interdepartmental meetings.

What is Required:
  • Doctoral (Ph.D.) or Masters (M.S.) degree in Analytical Chemistry or related discipline plus 3+ years of relevant industrial experience, or BS +10 or more years' experience
  • Experience with analytical development of small molecules and solid oral dosage forms in various stages of development (preclinical to Phase 3, with an emphasis on late stage development)
  • Extensive analytical method development, troubleshooting, and validation experience
  • In-depth experience with the development and validation of analytical methods (HPLC, GC, dissolution, compendial methods, etc.), identification of impurities and degradation products, reference standard qualification.
  • Demonstrated knowledge of drug development, CMO management, manufacturing, and regulatory CMC for development and commercial stage programs
  • Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices
  • Experience writing analytical sections of regulatory filings (IND, NDA, IMPD, MAA)
  • Outstanding written and verbal communication skills
  • Ability to effectively organize and prioritize tasks to achieve established deadlines
  • Ability to multi-task and good adapt rapidly to changing business requirements in a dynamic corporate environment
  • Proven problem-solving skills are a must
  • 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.