Shire Senior QC Scientist in Lexington, Massachusetts
This role supports method introduction and compliance for the testing of raw materials for GMP use in manufacturing. This support is primarily achieved by the management/completion of complex projects such as material risk assessments, method development, method validations and qualifications, compendial method verification, and training analysts for routine us of test methods as necessary.
In addition, this role is expected to lead a team of analysts dedicated to method introduction and manage new material introductions as required.
Responsibilities - Job duties include the following as needed
Risk assess new materials to determine test methods and validation/qualification requirements
Develop and validate/qualify new test methods
Compendial method verification
Manage new material introduction to support tech transfers
Provide training on new methods to analyst
Project management – new instrument/equipment implementation, SOP creation/revision, validation/verification protocol generation/execution
The ideal candidate will possess strong interpersonal communication skills, the ability to work well in a team setting, as well as, independently. This position is primarily a project/people management role, where the individual must be able to meet deadlines while working with little to no supervision.
An advanced knowledge of cGMP and industry standards pertaining to Quality Control Raw Materials inspection, sampling, testing, and approval is essential. Prior regulatory inspection experience is necessary.
In addition, the candidate must have experience using compendial methodology, such as the United states Pharmacopeia, and the European Pharmacopeia.
Education and Experience Requirements:
BS in Chemistry/Biochemistry/Biology with 7 to 10 years of relevant experience
Travel between sites is required. Weekend and off hours work may be required.
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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.