Technical Operations Manager
Molecular Templates (MTEM) is a clinical stage biopharmaceutical company targeting a variety of cancers through development of its innovative proprietary Engineered Toxin Body (ETB) platform. MTEM's first immunotoxin, MT-3724, is in clinical development for non-Hodgkin's lymphoma. Pipeline products for additional oncology targets are being advanced toward clinical development. For more information, please visit MTEM's website at www.mtem.com.
Molecular Templates is seeking a highly-experienced and dynamic professional to lead efforts supporting technical operations related to clinical bioanalytical methods, diagnostic and biomarker testing, and clinical drug supply. This Manager will design, implement and analyze clinical pharmacokinetic, pharmacodynamic and drug metabolism studies working in collaboration with clinical pharmacology, clinical operations, and nonclinical development teams. This position will be responsible for quantitative evaluation of new products and maintenance of existing pharmacokinetic and pharmacodynamic assays and data through the application of state-of-the-art knowledge in pharmacokinetics, pharmacodynamics, biomarkers, and bioanalytical method development. This position will also support efforts related to clinical drug supply in collaboration with other departments. This position will require excellent technical, analytical and problem-solving skills, along with ability to operate independently and to collaborate with cross-functional teams and contractors.
Job Responsibilities will include:
- Provide scientific expertise to the conduct, management, and development of pharmacokinetic (PK) and pharmacodynamic (PD), immunogenicity, and diagnostic assays.
- Contribute to PK/PD data analysis, interpretation, and summary.
- Author and revise departmental SOPs.
- Manage clinical drug supply in conjunction with Quality and Manufacturing in efforts related to: labeling, expiry, and supply/demand forecasting.
- Provide clinical support via technical operations including but not limited to: preparation and review of sample collection and management documentation, support bioanalytical method development, manage supply and quality of critical assay reagents, author summaries of PK/PD and immunogenicity data for internal and external stakeholders.
- Manage central lab efforts related to: definition of PK/PD and immunogenicity testing plan, review of study protocol and reports, management of method transfer and validation, compound and biological sample testing, shipment and storage of biospecimens.
- Contribute to clinical studies reports and regulatory submissions.
- Maintain knowledge of bioanalytical methods and trends, while assessing impact on product development and operational planning.
- MS or Ph.D. in biochemistry, chemistry, or related Life Science degree
- 8+ years of experience in pharmaceutical industry, with 2+ years directly supervising or managing technical operations efforts
- Proven experience and expertise with method development and validation, and analysis of study samples for PK and immunogenicity bioanalytical assays in a regulated environment in the pharmaceutical industry.
- Experience managing Central Laboratory testing efforts related to product specific assays and diagnostics
- Experience managing clinical drug supply
- Excellent written and verbal communication skills
- Excellent computer skills
- Excellent project management skills
- Excellent analytical skills and problem-solving skills
- Ability to review and summarize PK, PD and immunogenicity data
- Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment
- Ability to work collaboratively with cross-functional teams and contractors in order to drive results and meet company objectives
- Ability to function independently and exercise good judgement, as well as in a team-based environment
- Minimal travel required
This position currently has no supervisory responsibilities. This position reports to SVP, Operations & Head of Manufacturing.
Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.