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Senior Manager, CMC Project Management

Company: HCPro
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Senior Manager, CMC Project Management - TOQA2020R1005 Company: HCPro, Inc.

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Senior Manager, CMC Project Management - TOQA2020R1005

AP Senior Manager, CMC Project Management - TOQA2020R1005Alnylam Pharmaceuticals

Cambridge, Massachusetts, United States

1 day ago

Description

Senior Manager, CMC Project Management – Late Stage

Overview

Alnylam is the world’s leading RNA interference (RNAi)company.

Founded in 2002, Alnylam was built upon a bold vision of turningscientific possibility into reality by harnessing the power of RNAifor human health as an innovative new class of medicines. We are agrowing biopharmaceutical company with two approved medicines and arobust pipeline of investigational medicines focused in fourstrategic therapeutic areas: genetic medicines, cardio-metabolicdiseases, infectious diseases, and central nervous system (CNS) andocular diseases, including several in late-stagedevelopment. Headquartered in Cambridge, Mass., Alnylamemploys over 1,400 people in 19 countries and is rapidly growingglobally, with additional offices in Norton, Mass., Maidenhead,U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan.Alnylam is proud to have been recognized as one of The BostonGlobe’s Top Places to Work five years in a row (2015-2019), a GreatPlace to Work in the U.K. and Switzerland in 2020 and ScienceMagazine’s #1 Top Employer in 2019. Please visit www.alnylam.com for more information.

Incumbent provides project management leadership and support tocross functional teams and respective expertise areas responsiblefor the completion of tasks required for late stage clinical andcommercial development of new products. The incumbent willcollaborate with expertise area representatives on these tasks toestablish and manage timelines, budgetary oversight, resourceloading and risk mitigation plans. This role is responsible formanaging those deliverables required to fulfill projects forTechnical Operations and Quality as well as CMC requirements andtimelines for all regulatory submissions.

Summary of Key Responsibilities

Partner with CMC Technical Leads to manage multiplecomplex development projects to achieve product development andmanufacturing goals

Drive timely decisions and facilitate active communication andinformation flow between team members, Program Teams and impactedsites / expertise areas.

Collaborate with technical lead and expertise areas (RegulatoryAffairs, Manufacturing, Manufacturing Operations Support, ProcessSciences, Supply Chain and Quality) to establish project plansincluding budgetary oversight, resource loading and riskmitigations for the Technical Operation and QualityOrganization.

Support the management oversight of internal and externaltechnical requirements with partners, CMOs, and CROs to ensureproject success and that contractual obligations and deliverablesare met.

Management of project plans and timelines for the completion ofall activities required to develop, prepare and submit theChemistry, Manufacturing, and Controls (CMC) sections of Alnylam’sregistration dossiers and amendments for all products

Schedule and run cross functional team meetings to manageexecution of project plan, including authoring of minutes,assignment of action items and tracking of performance metrics

Facilitate the process for evaluation of alternative actions tooperationally deliver plan. Influence and drive development ofsolutions, criteria, and implications.

Prepare and present project status reports and metrics toProgram Teams and Management.

Requirements

Qualifications

Bachelor’s degree in life sciences/engineering. Advanced degreepreferred.

6+ years of development & project management experience withinthe biopharmaceutical or pharmaceutical industry.

Ability to lead cross-functional teams required.

Exceptional planning and organizing skills to plan and manageresources against timelines and commitments; must excel in adynamic environment.

Ability to negotiate and influence partners towards anappropriate path forward.

Strong interpersonal and communication skills.

Successful track record of both internal and external alliancemanagement.

Clear alignment with Alnylam Core Values: Commitment to People,Innovation and Discovery, Sense of Urgency, Open Culture, Passion for Excellence

Alnylam Pharmaceuticals is an EEO employer committed to anexciting, diverse, and enriching work environment.

#LI-CM1

Job Information

Job ID: 54481743

Location:

Cambridge, Massachusetts, United States

Position Title: Senior Manager, CMC Project Management -TOQA2020R1005

Company Name: Alnylam Pharmaceuticals

Job Function: Project Management

Job Type: Full-Time

Job Duration: Indefinite

Min Education: BA/BS/Undergraduate

Min Experience: 5-7 Years

Required Travel: None

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Keywords: HCPro, Inc., Cambridge , Senior Manager, CMC Project Management - TOQA2020R1005, Other , Cambridge, Massachusetts

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Keywords: HCPro, Cambridge , Senior Manager, CMC Project Management, Other , Cambridge, Massachusetts

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