CMC Project Manager responsibilities include, but are not limited to, the following:
- Independently plan, manage, and execute CMC project management in support of cGMP early-phase GMP biopharmaceutical product development.
- Lead project meetings including presenting dashboards and planning and tracking project timelines to drive to project completion. Facilitate discussions of progress, risks, timelines, and budgets.
- First point of contact to troubleshoot a wide variety of challenges encountered with project activities. Coordinate with external vendors on testing, reporting, and quality documents. Proactively communicate issues to key stakeholders to ensure a timely resolution and escalate as needed to ensure timelines are met.
- Collaborate to develop and plan testing required for investigations and responses to regulatory agency queries.
- Author protocols, reports, and filings. Coordinate with subject experts to review external analytical data and quality documents as needed.
- Proactively seek out senior collaborators to discuss potential solutions to problems. Ability to clearly present results of work, interpret data and draw conclusions.
- Work collaboratively with cross functional departments to manage project activities.
- Maintain current knowledge of relevant cGMP regulation, regulatory guidance’s, and internal SOP requirements for method transfer activities.
Basic Minimum Qualifications:
- BS/ MS degree in Pharmaceutical, Biological, or Chemistry discipline, and a minimum of 5 years of relevant experience in drug development or commercial product support.
- Authorization to work in the United States indefinitely without restriction or sponsorship.
The ideal candidate would possess:
- Minimum 3 years in pharmaceutical development/manufacturing with a focus on CMC and biologics.
- Project management training is desirable.
- Demonstrated ability to apply advanced level of understanding to project goals and methods with experience contributing to the development of project strategy.
- Demonstrated experience with project management programs and project communication tools.
- Ability to keep a cross-functional project team on task, on time, and within budget to achieve common goals.
- Excellent written and verbal communication skills and experience interacting with people from a wide range of skill levels and experience.
- Ability to communicate complex scientific findings and recommendations in one-on-one discussions and departmental meetings.
- Excellent technical writing experience in a regulatory environment such as protocols, reports, and SOPs.
- Demonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven, and highly flexible team-player in a fast-paced working environment.
- Strong computer, scientific, and organizational skills.
- Excellent attention to detail; excellent project management skills including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.
- Ability to work independently and as part of a team with internal and external clients, self- motivated, adaptable, and a positive attitude.
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
Position is Full Time, Monday-Friday, 8am-5pm with overtime as needed. Candidates currently living within a commutable distance to the Torrey Pines region of San Diego, CA are encouraged to apply.
What we offer:
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Yearly goal-based bonus & eligibility for merit-based increases
- Compensation: $75,000-$95,000 per year
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
