Project Manager - Drug Product

Location
Rensselaer, NY, United States
Posted
Jul 16, 2019
Ref
16122BR
Required Education
Bachelors Degree
Position Type
Full time
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 molecule-specific program to ensure that drug product projects are being executed according to an overall life cycle management strategy. The DP PM collaborates with cross-functional departments as well as Contract Manufacturing Organizations (CMOs) 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. Ensure 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 deliverables in a matrix organization to plan and execute the development strategy for the assigned Supply Chain projects (Technical Transfers, Process Validation, new CMO selection, CapEx, Life Cycle Management and Continuous Improvement).

• Acts as single point of contact for assigned project related communications with CMOs and CMC Program Manager.

• Leads multiple projects and priorities with excellent organizational and time management skills.

• Planning and tracking of the project activities. Ensures teams and stakeholders are aligned on one single drug product manufacturing project plan.

• Organization of regular project focused meetings with CMO and working teams (technical transfer, validation, new product launch, etc.).

• Facilitates contingency and risk mitigation planning and performs impact assessments for DP projects. Oversees, where appropriate, the development of the integrated project budgets, forecasts and timelines and is accountable to monitor progress against the approved baseline and manage project KPIs.

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

• May manage a team of Associate PMs and/or Project Specialists who assist in managing sub-projects for these programs.

• Ability to travel up to approximately 40%, domestically and internationally.

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.) preferred.

• 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 or Engineering discipline with a minimum of 8+ years of industry related experience, or equivalent combination of education and experience.

• Project Manager requires a BA/BS in any Physical or Biological Science or Engineering discipline with a minimum of 10+ years of industry related experience, or equivalent combination of education and experience.

• Prior pharmaceutical industry experience strongly preferred; may consider relevant experience in another regulated manufacturing environment.

• PMP certification or MBA a plus.

*Level will be determined based on qualifications relevant to the role.

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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