What are the responsibilities and job description for the PROJECT MANAGER position at Regeneron?
JOB DESCRIPTION
Regeneron is currently looking for a Project Manager to join our QC (Quality Control) AS (Analytical Sciences) team. The Project Manager - QC AS works to supervise coordination and preparation of change control documentation for AS related to early phase project deliverables. Identify, define and progress the early phase project deliverables for Analytical Sciences for pre- PPQ programs. Working with internal SMEs and customer groups in a matrixed team environment, ensures that analytical test methods and supporting quality deliverables are established in QC testing laboratories to support product manufacturing.
- Supervises coordination and preparation of change control documentation for Analytical Sciences related to early phase project deliverables.
- Attends early phase CMC program meetings as a representative of Analytical Sciences to serve as the primary point of contact and identify timing of key program breakthroughs, changes to program strategies and issues/concerns for programs. Proactively disseminates this information to AS management and SMEs.
- May oversee programs and activities that are outsourced at external contract laboratories.
- May own the implementation of CAPAs for Analytical Sciences and/or assist with quality events.
- Communicates cross-functionally within Analytical Sciences to identify the method development needs and timing for each early phase program.
- Develops a cohesive strategy for each early phase program and is responsible for the execution of that strategy.
- Engages in technical discussions cross-functionality to ensure the appropriate analytical deliverables are identified.
- Uses technical knowledge to ensure customer groups are provided with the appropriate analytical services including ensuring appropriate assays are in place for manufacturing sampling plans.
- Ensures that team members are informed and accountable for their deliverables. Brings up any issues to management and proactively recommends solutions.
- Works cross-functionally with partner groups such as CMC Reg Sci, Quality Assurance, Manufacturing, Process Sciences and Tech Training to identify the need for supporting documentation for early phase analytical programs including reports, technical documents and forms, and supports review of documents with impact to Analytical Sciences.
- Collaborates with CMC Reg Sci to support regulatory filings
- Identifies and implements effective tools for the group to improve the quality and efficiency of the matrix analytical development team.
- Regularly prepares and communicates program updates to senior management.
- Navigates a fast-paced and ambiguous environment to create a detailed program plan with defined deliverables and timelines.
This role night be for you if you have:
- Excellent organization, oral and written communication skills.
- Experience with MS Project or related project management tools.
To be considered for the Project Manager- QC AS you must be willing and able to work Monday-Friday, 8am- 4:30pm. You must have a BA/BS in Life Sciences or related field or equivalent combination of education and experience. For various levels you must have the following:
Associate Project Manager: 8 years of relevant experience
Project Manager: 10 years of relevant experience
Sr. Project Manager: 12 years of relevant experience
Leadership experience is preferred. PMP certification is preferred. Level is determined based on qualifications relevant to the role.
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Does this sound like you?to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
Salary : $86,900 - $194,200
