Sr. Scientist - Bioassay
, Massachusetts
November 20, 2017
Primary Duties
As a member of the Analytical Development Method Development team, he/she will lead and manage a small team of about 1-2 junior level scientists in method development, qualification and characterization of drug substance, drug product and reference standards for biological programs. Responsibilities include developing, qualifying and transferring analytical methods to HTP, QC and CROs. Clear understanding of QbD, ICH, and GMP guidelines is essential.
  • Lead and develop a small team of method development scientists based on Shire strategy including sourcing strategy
  • Method development across Bioassay/Potency for the purpose of development and GMP testing in HTP and QC settings including the required documentation
  • Test Method transfer to HTP and QC labs (internal and external)
  • Method improvement / replacement with modern technology
  • Continuous improvement of the methodology and business processes used in method development, related documentation, test method transfer, improvement and other related fields
  • Support biological manufacturing process challenges with PDTS subgroups Responsibilities
    60% Lab Function: Management, training, designing experimental studies, and performs method developmental activities
    25% Documentation including writing protocols, reports, and regulatory documents
    15% Training and presenting data
    Education and Experience Requirements
    MS with at least 10 years of management experience or PhD with at least 3-5 years of management experience in analytical chemistry, biochemistry or other biological discipline.
    Key skills, Abilities, and Competencies
  • Managing a small group (1-2) of scientists is essential
  • Strong analytical and problem solving skills are required
  • In-depth knowledge of Bioassay, and protein binding and enzyme activity measurements, including both theory and practice is required
  • Ability to work successfully in both a team/matrix environment as well as independently
  • Ability to work in a fast pace environment, manage priorities, and flexible to work on multiple projects
  • Knowledge of cGMPs, regulatory guidelines and good laboratory practice are essential
  • Excellent written and verbal communication skills are essential Complexity and Problem Solving
  • Management of analytical scientists and CROs
  • Complex problem solving
  • Thorough understanding of ICH, USP and GMP guidelines Internal and External Contacts
  • Position is accountable to the Head of the Method Development Bioassay/Immunoassay
  • Internal and external Shire departments
  • CROs and CMOs Other Job Requirements
  • Available for minimum travel
  • Available to participate in early or late meetings/teleconferences

A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.

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