Project Manager, Drug Product Project Management

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Using strong project management experience and knowledge of product manufacturing, the Drug Product Project Manager (DP PM) is responsible for managing at least one major project or program and ensures that drug product projects are being executed according to an overall strategy. The DP PM collaborates with cross-functional departments to plan, manage and drive project activities within agreed quality, scope, budget and time. Builds and maintains productive relationships with a wide variety of internal and external stakeholders. Ensures superior quality and timeliness of project deliverables.

Essential Duties and Responsibilities may include, but are not limited to, the following:

• Leads cross-functional teams and manages the planning and execution of deliverables for Fill/Finish operational and start-up readiness.

• Leads workstream and/or projects and prioritizes using excellent organizational, communication and time management skills

• Ensures teams and stakeholders across IOPS (Industrial Operations & Product Supply) are aligned on the Start-up and Manufacturing project plan. Plans and tracks the project activities.

• Facilitates regular project focused meetings with working teams (operational & Start-up readiness, Validation, Technical Transfer, etc.).

• Coordinates contingency and risk mitigation planning for projects.

• Ensures meeting minutes and weekly/monthly reports are completed accurately.

• Oversees, where appropriate, the development of the integrated project budgets, forecasts and timelines and is accountable to monitor progress against the approved baselines and manage project KPIs.

• May manage a team of Project Specialists who assist in managing sub-projects, Fill/Finish or Drug Product projects.

• May manage Drug Product projects related to the development strategy for at least one molecule-specific program (i.e. Technical Transfers (internal manufacturing or CMO), Process Validation, CapEx, Life Cycle Management and Continuous Improvement).

• Travel up to 25%

Knowledge, Skills, and Abilities:

• Strong project management, interpersonal, cross- cultural, communication, negotiation and problem solving skills qualification preferable.

• Exhibits a degree of ingenuity, creativity and resourcefulness in a sometimes evolving and ambiguous environment.

• Understands and listens to team members and stakeholders while fostering a productive team environment to one common project objective.

• Driven for proactive resolution of project related issues with tact, diplomacy and composure.

• Shows resiliency and flexibility in the face of challenges and adversarial situations.

• Able to provide clear direction to others in ambiguous situations and environments.

• Exhibits confidence and a high emotional IQ.

• Knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, etc.)

• Applies technical expertise (in their area) and may contribute to the development of new concepts, techniques and standards.

• Proficient in advanced techniques with relevant software: MS Project, Excel, PowerPoint, Word, etc. in addition to experience working within shared work environments.

Education and Experience:

• Associate Project Manager requires a BA/BS in any physical or Biological Science with 8+ years industry related experience, or equivalent combination of education and experience. Strong preference towards BA/BS in an engineering discipline.

• Project Manager requires a BA/BS in any physical or Biological Science with 10+ years industry related experience, or equivalent combination of education and experience. Strong preference towards BA/BS in an engineering discipline.

• Pharmaceutical industry experience required.

• Experience with Fill/Finish strongly preferred.

• PMP certification or MBA a plus.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
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