Shire Development Specialist in Lexington, Massachusetts

Primary Duties

The primary role is to support the analytical sample testing and documentation of results for process development. He/She will be responsible for preparing buffers, managing reagent inventory, maintaining instrumentation and executing experimental procedures and reporting data in a timely manner. He/She will be a contributor in the method qualification and transfer as needed, reviewing protocols, reports as needed.

Responsibilities

80%: Execution of existing Test Methods

10%: Documentation of results

10%: Troubleshooting, control trending, assay transfer and qualification support as needed

Education and Experience Requirements

BS with 2-4 years or MS with 1-2 years’ experience in Analytical, Chemistry, Biochemistry or other biological discipline. Experience in biotechnology, pharmaceutical, or related environment. Skilled in the application of one or more technical skills. Experience in method transfers, assay qualification is a plus

Key Skills, Abilities, and Competencies

  • Proficiency in diverse analytical techniques like HPLC, DNA, Electrophoresis is required along with basic biochemistry laboratory techniques

  • Computer competency is essential with emphasis on spreadsheet-based software.

  • Accurate documentation and communication skills

  • Ability to adhere to strict cnGMP procedures when applicable is required

  • Strong analytical and problem solving skills

  • Ability to report issues as needed

  • Ability to work in a team

Complexity and Problem Solving

Solves routine problems of limited scope and complexity. Operates under compliance requirements and systematically seeks guidance on policies and practices

Documents data accurately and completely as per established company guidelines and SOPs. Will be able to work independently with some supervision.

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, 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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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.