CMC Project Manager
Eurofins Lancaster Laboratories Professional Scientific Services, LLC

Company Description

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

If you're looking for a rewarding career, a place to call home, apply with us today!

Job Description

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.

Qualifications

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.

Additional Information

Position isFull Time, Monday-Friday, 8am-5pm with overtime as needed.Candidates currently living within a commutable distance to the Torrey Pines region of San Diego, CAare 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

Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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