Cmc Operations Lead

Molecular Templates, Inc. (MTEM) is a clinical stage biopharmaceutical company focused on the discovery and development of biologic therapeutics for the treatment of cancer and other serious diseases. The company primarily develops a pipeline of therapies through its proprietary biologic engineered toxin body (ETB) drug platform with unique mechanisms of actions which are highly differentiated from antibody drug conjugates (ADCs). MTEM is developing MT-6402, which is in a Phase I clinical trial for PD-1/PD-L1 antibody relapsed/refractory patients; MT-5111, which is in a Phase I clinical trial for the treatment of HER2-positive cancers; and MT-0169, which is in a Phase I clinical trial to treat relapsed/refractory myeloma. Additional preclinical compounds derived from our ETB platform technology are being advanced toward clinical development.  Additional information about MTEM can be obtained at www.mtem.com.   

 

 

Position Overview:

 

 

Seeking an experienced and dynamic professional to lead and direct biopharmaceutical CMC development activities for new and advanced products.  This role requires excellent technical knowledge in biopharmaceutical drug substance and drug product development, analytical development, demonstration of sound decision making and problem-solving skills. As a lead, you possess the ability to operate independently, collaborate with cross-functional teams, contractors, and external regulatory agencies to guide and support the preparation of CMC regulatory submissions. The CMC Operations Lead (COL) is responsible for technical oversight of external manufacturing partners (DS and DP) to ensure executional success for the delivery of clinical supplies.

 

This role will be responsible for: coordinating, tracking and curating characterization data to understand the impact of manufacturing processes, handling, storage and transportation conditions on drug substance and drug product quality attributes across the supply chain from initiation of drug substance manufacture to finished goods administered to patients. This includes clinical in-use studies to define dosing schemes as well as technical oversight of drug product manufacturing process development.

 

This role will extend to outside groups, such as contract development organizations and contract testing laboratories by overseeing services pertaining to production of drug substance, drug product, and analytical characterization studies. You will work closely with Upstream, Downstream, Analytical Development, Quality, and Manufacturing teams to participate in defining the broader control strategy across all production unit operations to attain CQAs at target specifications with batch-to-batch consistency. 

 

 

Job Responsibilities:

 

• Lead CMC regulatory filings and responses.
• Establish timelines and champion follow-through on commitments to regulatory health authorities.
• Lead the asset-specific cross-functional CMC Operations Team responsible for the delivery and execution of clinical supplies (establish supply/demand for external DS manufacturing and DP manufacturing)
• Support internal and external CMC activities required for regulatory filings
• Prepare reports as needed for CMC modules for development and registration applications, annual reports, amendments, and supplements for submission
• Serve as CMC Operations expert and primary technical contact with external and internal partners
• Support Product Quality Risk Assessments (PQRAs) and studies to fill data gaps with potential impact on product safety and biological performance

 

 

 

Qualifications:

 

 

• Advanced degree in the Life Sciences or related field, required
• Minimum of eight (8) years of relevant experience in pharmaceutical, biotechnology or a related industry focused on drug development. Experience may substitute education
• Demonstrated experience with large molecule biologics and a minimum of two (2) years involved with CMC operations directly
• Experience with biological process development, analytical, formulation and drug product development
• Knowledge of upstream, downstream bioprocessing unit operations and analytical development in establishing control strategy
• Knowledge of establishing CQAs and use of batch release and stability data to justify DS and DP specifications
• Experience with extended biologic product characterization and comparability studies
• Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment
• Ability to work collaboratively with cross-functional teams and contractors to drive results and meet company objectives
• Ability to function independently and exercise sound judgement, as well as in a team-based environment
• This is a hybrid eligible role

 

 

Reporting Structure:

 

This position does not have supervisory responsibilities and reports to the Sr. Director, Product Attribute Sciences.

 

 

Molecular Templates celebrates and supports our differences and is proud to be an Equal Employment Opportunity employer.  We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, veteran status, disability, or any other legally protected characteristic.  

MTEM is committed to providing reasonable accommodations for qualified individuals.  If you need assistance with your application due to a disability, you may contact us at: careers@mtem.com.

By submitting a resume for consideration, applicants verify that they have read MTEM’s Applicant Privacy notice. https://www.mtem.com/privacy-policy