CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Senior Manager, CMC Project Management

Company: HCPro
Location: Cambridge
Posted on: September 14, 2020

Job Description:

Senior Manager, CMC Project Management - TOQA2020R1005

AP Senior Manager, CMC Project Management - TOQA2020R1005 Alnylam 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 turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with two approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development. Headquartered in Cambridge, Mass., Alnylam employs over 1,400 people in 19 countries and is rapidly growing globally, 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 Boston Globe’s Top Places to Work five years in a row (2015-2019), a Great Place to Work in the U.K. and Switzerland in 2020 and Science Magazine’s #1 Top Employer in 2019. Please visit  www.alnylam.com  for more information.

Incumbent provides project management leadership and support to cross functional teams and respective expertise areas responsible for the completion of tasks required for late stage clinical and commercial development of new products. The incumbent will collaborate with expertise area representatives on these tasks to establish and manage timelines, budgetary oversight, resource loading and risk mitigation plans. This role is responsible for managing those deliverables required to fulfill projects for Technical Operations and Quality as well as CMC requirements and timelines for all regulatory submissions.

Summary of Key Responsibilities

Partner with CMC Technical Leads to manage multiple complex development projects to achieve product development and manufacturing goals

Drive timely decisions and facilitate active communication and information flow between team members, Program Teams and impacted sites / expertise areas.

Collaborate with technical lead and expertise areas (Regulatory Affairs, Manufacturing, Manufacturing Operations Support, Process Sciences, Supply Chain and Quality) to establish project plans including budgetary oversight, resource loading and risk mitigations for the Technical Operation and Quality Organization.

Support the management oversight of internal and external technical requirements with partners, CMOs, and CROs to ensure project success and that contractual obligations and deliverables are met.

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

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

Facilitate the process for evaluation of alternative actions to operationally deliver plan. Influence and drive development of solutions, criteria, and implications.

Prepare and present project status reports and metrics to Program Teams and Management.

Requirements

Qualifications

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

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

Ability to lead cross-functional teams required.

Exceptional planning and organizing skills to plan and manage resources against timelines and commitments; must excel in a dynamic environment.

Ability to negotiate and influence partners towards an appropriate path forward.

Strong interpersonal and communication skills.

Successful track record of both internal and external alliance management.

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 an exciting, 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

Jobs You May Like AP

Director, Global Quality Management System -...

Alnylam Pharmaceuticals

Cambridge, Massachusetts, United States

AP

Associate Director, Patient Safety & Risk Mgmnt -...

Alnylam Pharmaceuticals

Cambridge, Massachusetts, United States

AP

Senior Manager, Facilities - TOQA2020R1003

Alnylam Pharmaceuticals

Cambridge, Massachusetts, United States

Associate Director Commercial Operations,...

100 Winners Circle, Suite 300 Brentwood, Tennessee 37027 (978) 624-4594

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Seasonal Reduced Time Amazon Warehouse Worker - Up to $18.25/hr
Description: Seasonal Reduced-time Warehouse Team Member - 1000 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 1000 bonus Limited-Time Opportunity Location: Milford, MA Job (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/28/2020

Waste Management: Diesel Truck Technician Mechanic
Description: Waste Management WM , a Fortune 250 company, is the leading provider of comprehensive waste and environmental services in North America. We are strongly committed to a foundation of operating excellence, (more...)
Company: Waste Management
Location: Woonsocket
Posted on: 09/28/2020

Amazon Workforce Staffing: Seasonal Full-Time Warehouse Operator - $1000 Sign-On Bonus
Description: Seasonal Full-time Warehouse Team Member 1000 sign-on bonusHourly pay rate:Earn 15.25 16.25/hr, plus benefits and a 1,000 sign-on bonus. Limited Time OpportunityLocation:Bellingham, MAJob opportunities (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/28/2020


Seasonal Reduced-Time Warehouse Worker - $1000 Sign-On Bonus
Description: Seasonal Reduced-time Warehouse Team Member - 1000 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 1000 bonus Limited Time Opportunity Location: Milford, MA Job (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/28/2020

Warehouse Team Member Part-Time - up to $18.25/hr
Description: Seasonal Full-time Warehouse Team Member - 1000 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 1,000 sign-on bonus. Limited-Time Opportunity Location: Milford, (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/28/2020

Amazon Workforce Staffing: Seasonal Full-Time Amazon Warehouse Operator - $1000 Sign-On Bonus
Description: Seasonal Full-time Warehouse Team Member 1000 sign-on bonusHourly pay rate:Earn 15.25 16.25/hr, plus benefits and a 1,000 sign-on bonus. Limited Time OpportunityLocation:Bellingham, MAJob opportunities (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/28/2020

Truck Welder
Description: Waste Management WM , a Fortune 250 company, is the leading provider of comprehensive waste and environmental services in North America. We are strongly committed to a foundation of operating excellence, (more...)
Company: Waste Management
Location: Woonsocket
Posted on: 09/28/2020

Waste Management: Experienced Diesel Mechanics
Description: Take the next step and put your high level of skill hydraulics, electrical, diagnostics to good use with modern maintenance practices and technologies. We care about our Mechanic's safety and show it (more...)
Company: Waste Management
Location: Woonsocket
Posted on: 09/28/2020

Full-Time Amazon Warehouse Worker Benefits - Up to $18.25/hr
Description: Seasonal Part-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 500 bonus Limited-Time Opportunity Location: Milford, MA Job opportunities (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/28/2020

Waste Management: Truck Welder
Description: Waste Management WM , a Fortune 250 company, is the leading provider of comprehensive waste and environmental services in North America. We are strongly committed to a foundation of operating excellence, (more...)
Company: Waste Management
Location: Woonsocket
Posted on: 09/28/2020

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds