Celgene Project & Operations Manager in Summit, New Jersey
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Manager/Sr. Manager - Project & Operations Management – External Mfr. CTDO
This position will support projects in External Manufacturing & Strategic Sourcing Cell Therapy Development Operations.
He/she will be responsible for the project and operational management of projects from the initial formation of the team through agency filing (e.g. BLA, MAA, JNDA) and commercialization of the product along with clinical manufacturing at CMOs.
He/she will work with functional leaders from GMSAT, QA/QC, Reg-CMC, Demand and Supply Planning/ Supply Chain, Clinical Scheduling and Patient Operation to develop a project plan/timeline and will provide operational support. Identify critical path activities and risks, development of contingency plans, cross-functional team meeting management and communication.
We are looking for a manager with the breadth of professional experience to provide project management as well as operational support where needed. Ensure operations involving Celgene functions site work smoothly and flawlessly. This role requires the ability to develop and maintain strong collaborative and cooperative working relationships with team members at third parties and across different functions and at different levels within the organization.
The roles and responsibilities include, but are not limited to, the following:
Manage multiple cross-functional External Manufacturing projects, with a focus on developing project overall plan and timelines, as well as providing operational support and project execution.
Closely work with Virtual Plant Team (VPT) leads in all aspects, requesting support for issue resolution, and provide support to establish strategic plans.
Work closely with QA/QC team to support internal multiple sites and CMO Change Control and deviation management.
Support patient operations to resolve conflicts of clinical scheduling at CMO and further processing at Celgene internal site network.
Effectively collaborate with functional leads, develop critical path analyses to identify potential ways to accelerate timelines, reduce costs or mitigate risks, arrange and manage team meetings and follow up on action items.
Work with finance in tracking budget, PO and invoices.
Tracks the critical path items on the timeline with the sub-teams and brings issues to full team attention.
Serves as a member of sub-teams to assure that functional deliverables are completed on time, on budget, and in line with project overall plan.
Proactively identify project risks and work with the team and team leader to develop contingency plans
Works with the functional leaders, develop KPI, team goals and objectives, as well as team presentations for Governance Committee meetings
Responsible for the preparation of monthly status reports, including those for the CTDO Leadership Team
Promote a culture of collaboration, cooperation, execution excellence, effective communication and cross-functional problem-solving to become a high-performing team.
Knowledge of the drug development, clinical and commercial manufacturing process in a GMP environment.
Working with CMOs in various global regions is a plus.
Flexible to work with teams in different time zones across the globe, global and local travel required.
Experience with biologics and or Cell Therapy desirable
Strong analytical, problem-solving, and critical thinking skills
Demonstrated ability to earn the trust of team members and management
Must be able to interact and communicate effectively at all levels of the organization
Must be competent in Project Management tools and methodologies
Excellent organizational and time management skills in a very fast pace and challenging and stimulating environment
Flexible and comfortable working with ambiguity as the program priorities change based on regulatory input, business, R&D and clinical trial outcomes
Mind set for execution and problem solving as a must!
Bachelor’s degree in Life Sciences discipline appropriate
Advance degree in life sciences and/or MBA would be a plus!
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our mission is to focus on the discovery, development, and commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. Energizing this mission are the uniquely talented individuals that bring their passion, creativity, and innovation to work every day. Bring your unique gene to our team.
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