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Senior Manager, CMC Project Management for Biologics
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At Proclinical, we are seeking a talented and experienced individual to fill the role of Senior Manager, CMC Project Management for Biologics, based in Pennsylvania.
Responsibilities
- Develop and manage integrated timelines across all Research and Development projects. This includes timelines for activities to support Vector Development, Process Development, Analytical Development, Process Transfer (to CMOs/Internal Manufacturing), Quality Control and Manufacturing (Drug Substance, Drug Product Fill/Finish and packaging).
- Work with the technical leads to ensure all CMC team deliverables and activities are aligned with all teams, departments and facilitate communication to ensure clarity.
- Coordinate and facilitate creation of project plans and ensure optimal execution against the plans.
- Identify and analyze project risks and help guide project teams to develop appropriate mitigation strategies.
- Maintain dashboards and team SharePoint.
- Provide Project Management support to coordinate and manage CMO activities as the BPPD team's primary point of contact.
- Organize and facilitate team meetings, agendas, project reviews, meeting minutes and action item follow-up by working closely with the team leaders.
- Work with the Regulatory Department to develop timelines to support CMC submissions.
Skills And Qualifications
- BS or higher and 5+ years of relevant industry experience.
- PMP certification and strong technical background preferred.
- Experience managing cross functional biopharmaceutical product development required.
- Excellent written, verbal, and interpersonal communication skills.
- Ability to travel, as becomes necessary.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Tong at (+1) 6468786308 or upload your resume on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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