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Project Manager, Technical Operations

C4 Therapeutics

This is a Contract position in Dallas, TX posted March 22, 2022.

C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives.

C4T is leveraging its TORPEDO platform to efficiently design and optimize small-molecule medicines that harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes.

C4T is advancing multiple targeted oncology programs to the clinic and expanding its research platform to deliver the next wave of medicines for difficult-to-treat diseases.

For more information, please visit .Our Opportunity:C4 Therapeutics is seeking a Tech Ops Project Manager who will be responsible for driving the following activities: Maintain project planning and budgeting for manufacturing activities associated with product development, chemical development, and commercialization.

The successful candidate will have a firm understanding of manufacturing and its associated cGMP quality systems.

This role will provide both tactical and strategic support for the Tech Ops team.

In addition, the Tech Ops Project Manager will support tracking and trending of supplier metrics and develop CMC/manufacturing SOPs as needed.

The Tech Ops Project Manager will also work closely with Quality, Regulatory CMC, Finance, Program Management, and other key external parties.

Reports to the Head of Technical Operations Project Management.The Role: You will ensure timelines (action items/pending issues) and budget are on track using established or developing project management tools.

Initiate and support independent projects that may be relevant to product manufacturing, chemical development, and serialization efforts.

Maintain product development filing structure for final documents and reports to support pre-approval inspections.

Support purchase order tracking activities from gathering the executed quotes or SOW’s, issuance of the purchase order and monitoring acceptance of the services or materials requested.

Support budgeting activities associated with product development, chemical development, and commercialization.

Execute on project plans, management of team’s project budgets, and provide clear and efficient communication of project status and issues to all stakeholders.

Coordinate/collaborate with CMC, External Manufacturing, Regulatory CMC, and Quality to facilitate internal change control requests.

Coordinate/collaborate with the management team to ensure manufacturing processes are properly documented, reviewed, and approved prior to implementation.

Author and maintain product specification documents including revisions of SOPs, as needed.

Provide support to the pharmaceutical sciences group for change controls, product specifications, SOPs, project quote requests, budget tracking, and manufacturing systems.

Build timelines, work breakdown structures, follow up with individuals on the completion of their tasks.

Proactively work with members of the CMC group to support project deliverables and activities.

Additional duties and responsibilities as required.Your Background: BS/BA degree, or equivalent, in science or related field of study.

5 years of relevant work experience in Pharmaceutical Manufacturing and/or Project Management.

Working knowledge of cGMP regulations and ICH and CDER guidelines applicable to the development and production of investigational and commercial drug products.

Strong working knowledge of project management and budgeting activities.

Direct knowledge of manufacturing processes and validation requirements, a plus.

Strong organizational skills and ability to coordinate and advance multiple project timelines, simultaneously.

Expected to think critically and see gaps in products or processes, show initiative and good judgment in developing solutions.

Experience using PowerPoint, MS Project or Excel Ability to effectively support and participate on multi-disciplinary program teams.

Strong interpersonal skills and excellent oral and written communication skills.

PMP certification is a plus

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