LeominsterRecruiter Since 2001
the smart solution for Leominster jobs

Director, Bioanalytical - Lexington, MA, US

Company: Translate Bio
Location: Lexington
Posted on: June 19, 2019

Job Description:




Job Summary


The Director, Bioanalytical reports to Executive Director, Translational Development and is an integral part of the Translational Development team. The BA Director is responsible for leading, building and expanding the bioanalytical team's expertise and capacity.






Job Responsibilities




  • Lead and grow a comprehensive bioanalytical function to support all stages of discovery and development for mRNA lipid nanoparticle therapeutics
  • Provide Scientific leadership and oversight of the Bioanalytical group, as well as providing expertise in Regulatory aspects of Bioanalytical to project teams
  • Manage bioanalytical assay method development, characterization, validation and method transfer (to external CRO's) of sophisticated bioanalytical methods
  • Manage CRO method transfer and sample analysis activities; review and approve Bioanalytical protocols, reports, associated summaries, regulatory sections and associated documentation
  • Support in-house early discovery projects related bioanalytical needs






    Required Skills & Qualifications




    • PhD in a pharmaceutical sciences related field
    • 10+ years of experience working in a Bioanalytical role within the pharmaceutical or biotechnology industry is required
    • Evidence of scientific/technical leadership in a range of BA methods to support small molecule, oligonucleotide, mRNA, proteomics, and immunogenicity assessments.
    • Extensive experience in the outsourcing and external oversight of regulated (GLP, GCP) Bioanalytical studies to support nonclinical and clinical activities.
    • Demonstrate knowledge of regulatory requirements and expectations for Bioanalytical packages to support regulatory filings and clinical studies including thorough knowledge of GLP, GCP, ICH and other applicable guidelines



Keywords: Translate Bio, Leominster , Director, Bioanalytical - Lexington, MA, US, Executive , Lexington, Massachusetts

Click here to apply!

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

I'm looking for
in category
within


Other Executive Jobs


Customer Success Manager
Description: OverviewEncompass-CX is seeking a Customer Success Manager who will be a critical team member responsible for the complete post-sale success and satisfaction in a rapidly growing company. The Customer (more...)
Company: Encompass-CX
Location: Boston
Posted on: 07/16/2019

Manager, Supply Chain, Global Vaccines Delivery
Description: Overview The Clinton Health Access Initiative, Inc. CHAI is a global health organization committed to saving lives and reducing the burden of disease in low-and middle-income countries, while strengthening (more...)
Company: Clinton Health Access Initiative, Inc.
Location: Boston
Posted on: 07/16/2019

Director of Admissions
Description: Colby-Sawyer College is a small, liberal arts college with enrollment of approximately 1,000 students located in New London, New Hampshire. The Director of Undergraduate Admissions is responsible for (more...)
Company: Colby-Sawyer College
Location: Boston
Posted on: 07/16/2019


Operations Manager
Description: Redi Carpet, the nations' largest flooring company is looking for an Operations Manager. This person coordinates the daily installation process by organizing the schedule, assigning crews, and supervising (more...)
Company: Redi Carpet
Location: Boston
Posted on: 07/16/2019

Assurance Manager
Description: Assurance Manager br br br br br br br br Opportunity ID br br 1369 br br br br Department s br br br br Assurance br br br br Location s br br br (more...)
Company: CohnReznick
Location: Boston
Posted on: 07/16/2019

Product Marketing Manager
Description: Job Overview:--aPriori is the leading provider of product cost management software featuring design for manufacturability and cost simulation capabililties. --Customers of aPriori include the word's most (more...)
Company: aPriori Technologies
Location: Concord
Posted on: 07/16/2019

Associate Director, Women's Health Program
Description: Join an organization at the forefront of health advocacy across the nation Community Catalyst, a national advocacy organization,--has been giving consumers a voice in health care reform for more than (more...)
Company: Community Catalyst
Location: Boston
Posted on: 07/16/2019

Account Manager
Description: Responsible for overall account management and is the primary point of contact for customers and is responsible for the day
Company: Risk Strategies Company
Location: Woburn
Posted on: 07/16/2019

Public Relations Account Director
Description: Denterlein, a dynamic public relations and strategic communications firm is looking to add an experienced Account Director to our team. If you are strategic and creative with client-facing, agency experience (more...)
Company: Denterlein
Location: Boston
Posted on: 07/16/2019

Commercial Account Manager
Description: The Allan M. Walker Insurance Agency is looking for a commercial lines CSR. We are looking for someone who is proficient on all aspects of commercial lines AND someone who wants to be enthusiastic
Company: Allan M Walker Insurance Agency
Location: Taunton
Posted on: 07/16/2019

Log In or Create An Account

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

Leominster RSS job feeds