CMC Project Manager

CMC Project Manager at TekWissen ® CMC Project Manager at TekWissen ® in Redwood City, California Posted in 1 day ago.

Type:

full-time

Job Description:

Position:

CMC Project Manager Location:

Foster City, CA 94404

Duration:

8

Months Job Type:

Temporary Assignment Work Type:

Hybrid Pay Rate :

$78.00-84.00/

Hr Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

FOCUS AREAS

Lead integrated CMC planning across Drug Substance, Drug Product, Analytical, Quality, Regulatory, and Supply Chain, aligning deliverables, timelines, and priorities with clinical and regulatory objectives. Drive execution of CMC plans to ensure alignment with program milestones and overall development timelines. Provide end-to-end project management support across the product lifecycle, from development through commercialization and commercial manufacturing. Develop, maintain, and manage integrated project timelines in Planisware or Smartsheet, clearly defining dependencies, milestones, and critical path activities. Facilitate cross-functional Product Team meetings, including agenda development, decision documentation, and action item tracking. Proactively identify, assess, and manage program risks and issues; maintain risk registers and ensure timely mitigation and corrective actions. Coordinate preparation of high-quality governance materials in collaboration with Product Teams. Translate complex technical input from subject matter experts into clear, actionable insights to support strategic decision-making. Ensure clear, timely communication of program status and key updates to all stakeholders. Partner with Product Teams and Finance on budget planning, tracking, and forecasting. Ensure compliance with established processes and practices; identify and share best practices across Product Teams and PMs. Integrating emerging AI and digital technologies into project management practices Qualifications Minimum 5-8 years of relevant experience and a BA or BS in Life Sciences or related disciplines preferred. Relevant experience consists of cross-functional work in biopharmaceutical /pharmaceutical CMC development and commercial teams, GMP environment and regulatory affairs Prior experience in project management required; PMP certification desirable Solid understanding of project management methodologies, tools, and techniques (Planisware familiarity is a plus) Excellent organizational skills, capable of setting priorities and delivering on commitments Strong interpersonal and communication skills. Demonstrated ability to collaborate closely with project leads, teams and scientific and business leadership. Strong leadership skills with the ability to motivate and inspire global cross-functional teams Ability to manage complex situations and adapt to changing business needs Proactive mindset TekWissen® Group is an equal opportunity employer supporting workforce diversity.