Shire Senior Scientist, Drug Product Process Development in Lexington, Massachusetts

The Senior Scientist, Drug Product Process Development / Engineering will be a technical lead for clinical, biologics drug product process development / engineering and clinical drug product manufacturing support for Shire biologics products. The individual will develop biologic drug products across all phase of clinical development including early phase development, late phase development, scale-up, process optimization, and technology transfers. The individual will also support process validation in preparation for commercial launch.

The Senior Scientist will closely collaborate with cross-functional Process Development and CMC team members including formulation development, technical services, process validation, drug substance process development, analytical development, quality control, quality assurance, and supplier relationship and manufacturing leads.

The role and responsibilities are to

  • Design drug product processes and establish processes at manufacturing sites. The Senior Scientist will lead and/or support cross-functional teams to define, coordinate, and track these activities.

  • Execute drug product process development laboratory studies or manage studies performed by external partners. These studies will be used to evaluate drug product processes in scale-down models, characterize process performance or limits, and screen process parameters.

  • Author development protocols and reports, prepare study materials, analyze data, and interpret results.

  • Technical management of drug product manufacturing sites or CMOs including representing Shire as a technical lead / subject matter expert during manufacturing site team meetings.

  • Identify solutions to technical challenges to enable on-time and on-budget delivery of clinical drug product. Communicate and defend rationale of proposed solutions to cross-functional teams as drug product process subject matter expert.

  • Support drug product manufacturing deviation investigations, CAPAs, and change control management.

  • Review and approval of manufacturing batch records, oversight of fill/finish operations, and supporting activities to enable clinical trial material supply

  • Author sections of regulatory submissions for drug product process development and manufacturing

Responsibilities

  • 35% Manage drug product process development and engineering activities, including coordinate cross-functional support as needed, for clinical development and supply of clinical trial material

  • 25% Execute, analyze, and interpret data for drug product process development laboratory studies including management of outsourced studies

  • 25% Technical management of manufacturing site / CMO operations and manufacturing activities

  • 10% Author and/or review drug product development protocols, reports, manufacturing batch records, and regulatory submissions

  • 5% Travel required for person-in-plant oversight for critical drug product manufacturing

Education and Experience Requirements

  • Minimum, BS degree in engineering, chemistry, biotechnology, or related science.

  • Minimum, 5-8 years experience in biologics drug product development including drug product process and formulation development

  • Aseptic fill/finish manufacturing experience and oversight of CMO operations

  • Thorough knowledge of global GMP regulations and guidance

  • Experience authoring technical protocols, reports, and CMC sections for regulatory submissions

  • Experience within a project team (preferably involving external partners)

  • Experience with quality exception management

Key Skills and Competencies

  • Excellent communication, technical, organizational, interpersonal and leadership skills are required

  • Must be a team player prepared to lead, work effectively and efficiently in a team-based environment

  • Ability to work in a fast-paced environment and handle multiple projects simultaneously

  • Critical evaluation of results and ability to defend strategic guidance to resolve technical issues

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.