Shire Senior QC Scientist in Lexington, Massachusetts

Primary Role:

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

Other Requirements:

Travel between sites is required. Weekend and off hours work may be required.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

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, gender identity, 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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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.