Shire Associate Director in Lexington, Massachusetts
As a member of 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
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 & 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 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 & 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 and Highthroughput
Internal and external Shire departments
CROs and CMOs
OTHER JOB REQUIREMENTS
Available for minimum travel
Available to participate in early or late meetings/teleconferences
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Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.