Project Manager - Chemistry, Manufacturing & Controls (CMC)

Company Description:

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.

Position Overview:

Molecular Templates is seeking a highly-experienced and dynamic professional to coordinate and manage CMC activities. This Project Manager will develop project plans and timelines related to product development, clinical trials, validation, and submission. This position will also monitor progress, identify concerns and risks and effectively communicate with management. 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 may include:

• Monitor and coordinate CMC activities related to in-house and outsourced Manufacturing and Quality
• Develop and obtain approval of CMC project plans which define scope, timelines, deliverables, risk management plan, communication plan, and budget for projects related to ETB development
• Utilize project management tools and methods to effectively manage, monitor, and report projects
• Define and manage contracted and in-house development milestones and ensure completion of deliverables on-time and on-budget
• Prepare requests for proposal (RFPs) which describe, but are not limited to: project scope, deliverables, milestones, and responsibility matrix sufficient to obtain bids for contracted work
• Review contract bids and vendor qualifications based on costs, risks, timelines, quality audits, and deliverables and provide recommendation of specific contract group for project execution
• Manage projects conducted by contract groups or in-house with efficient governance including contract execution, authorization of change orders, schedule and budget variance management, progress reporting to stakeholders, review of data and reports, completion of contract milestones, managing project meeting agendas and action items, and alignment of CMC efforts with corporate drug development efforts and priorities
• Communicate project status and outcomes with upper management and other project stakeholders with optimal efficiency and accuracy
• Prepare and submit MTEM project documents, reports and summaries
• Execute and manage new projects and other duties, as assigned

Qualifications:

• Advanced degree, required
• Minimum seven (7) years of relevant experience, at least 3-5 years of experience specific to project management of products in clinical development, including efforts related to CMC, preferably for large molecule biopharmaceutical products
• Comprehensive understanding of CMC efforts related to GMP
• Demonstrated knowledge of GMP/GCP US and EU regulations and regulations
• Proven experience evaluating/selecting vendors and managing contract relationships, particularly CMO and CRO management
• Proven knowledge and experience in project management
• Proficiency with ERP or other materials management systems knowledge, preferred
• Experience participating on and leading cross-functional project teams
• Excellent problem-solving, data analysis and computational skills
• Excellent time management and multi-tasking skills
• Excellent written and verbal communication skills
• Proven ability to design projects independently
• Ability to function independently and exercise high-level of judgement
• Ability to multi-task and work in a fast-paced, team environment
• Requires up to 20% travel

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.

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.

https://mtem.isolvedhire.com/jobs/54805-19034.html