Shire Sr Operations Analyst in Milford, Massachusetts

The Operations specialist is part of Milford’s Manufacturing group by participating in biologics manufacturing and development processes, proactively seeking opportunities for improvements, and performing investigations. Serves as Manufacturing representative for various interdepartmental projects and initiatives.

  • Continuous Improvement Initiatives

  • Transactional interdepartment tasks

  • Project Facilitation, audit responses

  • Change controls, deviation investigations and training/document updates

  • Training, performing manufacturing & development processes

  • Identification of risks to production processes and implementation of mitigations

  • Simplifcation of MFG standard work and visual management

  • OMT information and display

  • Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks

  • Serve as Subject Matter expert for manufacturing processes and address process-related questions and issues during audits and for resolving deviations

  • Perform manufacturing processes inside suite, including sampling

  • Assist technical services group with preclinical development activities

  • Assist in the creation of batch records and SOP’s for new processes

  • Align local practices with global initiatives

  • Lead CAPA investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence, documenting all phases in Event Management software

  • Assess issues and develop resolutions to meet department objective, which include safety, quality, cost, delivery.

  • Perform inventory transactions, document updates and training to support manufacturing activities.

  • Participate in data trending programs.

  • Responsible for rollout and sustainability of Business Excellence initiatives such as 5S, Gemba, OMT, DMAIC

  • Act as a liason between MFG and other department for planning, projects and to resolve issues

  • Identify and implement improvement initiatives to improve yield, reliability, and/or process robustness. This may require leading and implementing change controls

  • Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capability

  • Stay current with biopharmaceutical industry best practices and technologies

  • Responsible for organizing data and preparing appropriate documentation, including presentation materials, for assigned projects

Education and Experience Requirements

  • Bachelor’s degree required; scienctific discipline (biology, chemistry, engineering) preferred

  • Minimumm of 2 to 4 years of experience in CGMP manufacturing process required.

  • Previous manufacturing investigation, audit response and process subject matter expert required.

  • Experience as a team lead

Key Skills, Abilities, and Competencies

  • Must be able to work independently with minimal supervision.

  • Strong planning, prioritization and multitasking skills.

  • Must be able to effectively interact and communicate with all levels of management, colleagues and external auditors.

  • Must be abel to work within a team environment and model behaviors consistent with excellent teamwork.

  • Must have strong systems/applications and functional systems knowledge (QBMS, Trackwise, Veeva, SABA)

  • Possess a broad knowledge of Business Excellence tools (OMT, 5S, GEMBA)

  • Must have first hand experience with the processing of a biologic product.

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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.