Associate Director
Location:
, Massachusetts
Posted:
October 17, 2017
Reference:
R0012570
As a member of our Analytical Development Method Development team, he/she will lead and manage a small team of about 2 - 4 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 one discipline (Chromatograph, electrophoresis, enzyme activity, Coagulation, etc.) 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
Lab Function: Management, training, designing experimental studies, and performs method developmental activities (60% of time)
Documentation including writing protocols, reports, and regulatory documents (25% of time)
Training and presenting data (15% of time)

EDUCATION AND EXPERIENCE REQUIREMENTS
MS with at least 10 years of management experience or PhD with at least 5 years of management experience in analytical chemistry, biochemistry or other biological discipline.

KEY SKILLS, ABILITIES & COMPETENCIES
  • Managing a small group (2-4) of scientists is essential
  • Strong analytical and problem solving skills are required
  • In-depth knowledge of HPLC, UPLC, LabChip, SoloVPE, 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 paced environment, manage priorities, and flexibility to work on multiple projects
  • Knowledge of cGMPs, regulatory guidelines and good laboratory practice are essential
  • Excellent written and verbal communication skills essential
COMPLEXITY & PROBLEM SOLVING
  • Management of analytical scientists and CROs
  • Complex problem solving
  • Thorough understanding of ICH, USP and GMP guidelines
INTERNAL & EXTERNAL CONTACTS
  • Position is accountable to the Head of the Method Development Separation Science
  • 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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