Sr. Project Manager, Chemistry, Manufacturing & Controls (CMC)

Location
Austin, TX, USA
Posted
Nov 14, 2020
Ref
205421
Required Education
Masters Degree/MBA
Position Type
Full time
Company Description:

Molecular Templates is a clinical stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics for cancer. We believe our proprietary biologic drug platform technology, referred to as engineered toxin bodies, or ETBs, provides a differentiated mechanism of action that may address some of the limitations associated with currently available cancer therapeutics. ETBs utilize a genetically engineered form of Shiga-like Toxin A subunit, or SLTA, a ribosome inactivating bacterial protein, that can be targeted to specifically destroy cancer cells. Additional information about Molecular Templates can be obtained at www.mtem.com.

Position Overview:

MTEM requires a highly capable CMC Project Manager to drive successful execution of critical internal and external/alliance partner programs for manufacturing and commercialization of complex biologics such as recombinant protein Engineered Toxin Bodies (ETBs). The ideal candidate for this position must be highly proficient in both technical CMC process and Project Management skills while operating in a fast-paced dynamic environment.

Job Responsibilities:
  • Responsible for providing highly effective CMC project management leadership. Programs will require application of effective project management principles and precise timeline tracking across a span of areas and deliverables including, analytical Methods, Process Development, Non-GMP and GMP manufacture, IND submission, clinical supply for studies and NDA licensure.
  • Duties will include: Manage all aspects of CMC alliance collaborations with partner pharmaceutical companies including timelines, budgets, non-GMP and GMP manufacture, clinical study supply, regulatory filings, risk management and strategic planning.
  • Define, develop, and execute project plans for development programs from Candidate Selection through IND. This includes working with stakeholders to define subordinate non-clinical and CMC project plans.
  • Define project scope including activities, timelines, deliverables, risk management plan, communication plan, and budgetary plans, for assigned MTEM projects. This includes working with stakeholders to ensure establishment and or execution of approvable product specifications, batch record reviews, analytical method reviews, management of stability plans and reports, product investigation and CAPA summaries.
  • Support-out sourced contracting including vendor identification, evaluation (delivery capabilities, cost, budget and timing), RFP development, proposal evaluation, contract negotiation, contract execution, PR/PO generation, Change Orders, invoice review, deliverables acceptance and contract close-out.
  • Possess excellent problem-solving skills from a project managerial, operational, technical, financial, quality/regulatory perspective. Provide highly effective project management using PM tools such as Smartsheets, MS Project, 10,000 feet, MS Office Suite and Office365 (Word, Excel. PowerPoint, SharePoint, etc.) to maintain and communicate project information.
  • Manage projects with efficient governance including schedule and budget variance management, project dashboard/weekly updates to upper management, managing technical project meeting agendas, discussions and action items, etc., all in alignment with ongoing CMC development-manufacturing efforts and corporate priorities.

Minimum Qualifications:
  • Master's degree in Biochemistry, Molecular Biology or related field plus 4 years of combined experience with manufacturing, clinical development and project management is preferred.
  • Experience must include: experience with CMC efforts related to GMP (21 CFR good manufacturing practice); experience with GMP/GCP US and EU regulations; experience evaluating/selecting vendors and managing contract relationships, particularly CMO's and CRO's; experience as project manager to pharmaceutical product development teams

Reporting Structure:

This position currently has no supervisory responsibilities. This position reports to the Sr. Director, Biopharmaceutical Project Management.

Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.

Molecular Templates Inc https://mtem.isolvedhire.com