CMC Project Manager

TekWissen LLC

Job Location:

Foster, CA - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

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.

Position: CMC Project Manager
Location: Foster City CA 94404
Duration: 8 Months
Job Type: Temporary Assignment
Work Type: Hybrid

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.

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 prima...

Overview:

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.