Shire Lead, Delivery System Qualification in Lexington, Massachusetts

Lead, Delivery System Qualification

Primary Duties:

As a member of the in-use testing group, this position will support qualification testing of biologic/device combination products with a focus on Shire’s immunology and hematology product portfolios. This individual will design and execute feasibility, material compatibility and in-use qualification studies to demonstrate that the quality of Shire’s biological products is not impacted by the medical devices used in their administration. This position will participate in the transfer of test procedures and methods from other Shire laboratories to the Lexington site. He/she will be responsible for developing a platform approach for qualification of administration systems (including pumps) used for the delivery of Shire’s intravenous and subcutaneous products to support global market entries. This position will collaborate with internal medical device development teams in the identification of user needs and the design of verification and validation testing to assess any impact to the biological product.

Responsibilities

  • Design and execution of biological device qualification studies which may include analytical method qualification (60%)

  • Authoring documentation and data analysis (20%)

  • Participate in cross functional team meetings and discussions (10%)

  • Support regulatory submissions and responses to Health Authority questions related to device qualification and compatibility testing (10%)

Education and Experience Requirements:

MS in pharmaceutical sciences or engineering (biomedical or mechanical) with a minimum of 5 years of relevant industry experience

Key Skills, Abilities, and Competencies

  • In depth knowledge of biological macromolecules

  • Hands on experience with physical and bioanalytical characterization instrumentation such as viscometer, densitometer, SoloVPE, HPLC/UPLC (SE, RP, ion exchange), and MicroFlow Imaging Technology (MFI) technology and other particle characterization/identification techniques (preferred but not required)

  • Hands on experience with administration devices used for parenteral delivery of medicines

  • In depth knowledge and understanding of GMP, GLP, and GDP

  • Strong technical and problem solving skills

  • Excellent verbal and technical writing skills

  • Must be well organized and self-motivated, being flexible with assignments and adaptable to the changing needs of projects

  • Ability to work successfully in both a team environment as well as independently

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, 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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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.