Oversee and drive CMC project plans, ensuring deliverables align with the overall project objectives and timelines
Facilitate cross-functional collaboration by leading CMC sub-team meetings, preparing agendas, tracking action items, and maintaining meeting minutes.
Partner with Technical Operations, Legal, and Finance to negotiate and execute confidentiality agreements, consulting agreements, master service agreements, and work orders with CDMOs and CROs, following internal procedures.
Oversee development and execution of integrated project plans, including timelines, budgets, and resource allocation across multiple workstreams.
Partner with Technical Operations, Legal, Finance, and external CDMOs/CROs to negotiate and finalize agreements, ensuring compliance and timely execution.
Monitor and manage project budgets, forecast resource needs, and provide financial oversight to support decision-making.
Proactively identify and mitigate risks, maintaining risk registers and implementing contingency strategies to ensure program success.
Deliver high-quality reporting and communication, including executive-level updates, dashboards, and presentations for governance forums.
Champion process improvements and best practices, driving operational efficiency and consistency across Technical Operations projects.
Other responsibilities may be assigned as required by management

Requirements

BS degree required
Degree in life sciences/engineering strongly preferred, professional certifications (i.e. PMP) will be a distinct advantage
4+ years of experience supporting Technical Operations (Manufacturing, Analytical/QC testing, Packaging, Distribution)
Device Development experience highly desired
Excellent communication skills (both verbal and written) and interpersonal skills are required
Works well independently as well as in a team environment
Highly proficient in Microsoft Office applications and Smartsheet; comfortable and quick learner with other software systems
Demonstrates collaborative communication and problem-solving spirit.
Willingness to do what needs to be done in a dynamic environment.

Benefits

medical, dental and vision coverage
life insurance
disability insurance
401(k) savings plan
flexible spending accounts
employee assistance program
tuition reimbursement program
voluntary benefits such as group legal
critical illness
identity theft protection
pet insurance
auto/home insurance
sick time policy
flexible vacation policy
parental leave policy

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

project managementrisk managementbudget managementresource allocationprocess improvementdevice developmentanalytical testingquality control testingmanufacturingpackaging

Soft Skills

communicationinterpersonal skillscollaborationproblem-solvingindependenceteamworkleadershiporganizational skillsadaptabilityproactiveness

Certifications

PMP