Shire Operations Project Manager in Lexington, Massachusetts

Primary Role:

The Project Manager will lead projects of defined scope including the implementation of product & process improvements, corrective / preventative actions and change controls. They will support cross functional teams for clinical and commercial manufacturing initiatives. The individual will own projects and quality systems for manufacturing initiatives from initial planning and initiation, through implementation and closeout.

Responsibilities:

50%

Actively own and manage projects, CAPAs, and Change Control quality systems as they relate to Manufacturing-owned operations, processes, and equipment. This includes project plan development, execution, implementation, and closure through effective use of project management tools (project charters, agendas, meeting minutes, RACI, schedule):

  • Obtains agreement on project scope, objectives and priorities.

  • Ensures adequate resources are assigned and held responsible for project execution according to plan.

  • Leads the planning and execution of assigned projects and ensures they are implemented and closed on time

  • Monitors project progress and escalates issues appropriately

  • Provides status reports defining project progress, risks, problems, and solutions.

  • Identifies and mitigates risks to project execution.

  • Applies efficient work practices for project management and ensures continual improvement of practices with the use of lessons learned.

25%

Represent manufacturing’s best interests on cross-functional projects and teams. This may include the following:

  • Provide manufacturing impact assessments for change controls owned by other functional groups (e.g. Engineering, Tech Transfer, Materials Management, QC, etc.).

  • Participate on risk assessment and options analysis teams.

  • Provide manufacturing support for capital projects, technology transfers, and continuous improvement efforts.

  • Make decisions in manufacturing's best interests to ensure their short and long term needs are met.

  • Responsible for completing actions and deliverables for cross functional projects and teams.

  • May require support from direct line manager to provide the right information and/ or decisions.

25%

Perform base business activities:

  • Strive to meet defined metrics through the utilization of visual management boards.

  • Maintain adherence to assigned cGMP training requirements.

  • Participate in system improvements and optimization efforts to improve the output and throughput of various systems / processes (which may include OE or other efficiency intitiatives).

  • Participate in regulatory and internal audits which may include direct interaction with inspectors for CAPA or Change Controls, scribe duties, facilitation of audit requests, and/or development of responses.

Education and Experience Requirements

  • Bachelor’s degree or equivalent experience in Engineering or Science and 3+ years of relevant experience in commercial biotechnology or pharmaceutical production with experience in managing projects and schedule development is required.

  • Knowledge of cGMPs and applicability to manufacturing operations in a biologics or API environment is preferred.

Key Skills, Abilities, and Competencies

  • Must be proficient with Microsoft applications, including Project, Word, Excel and Power Point.

  • Demonstrates ability to be nimble, maintain a positive outlook, and remain composed under pressure.

  • Possess organizational / time management skills and ability to coordinate and prioritize multiple projects in a fast-paced, deadline-driven environment.

  • Good interpersonal skills and ability to work effectively and collaboratively in a cross-functional team environment.

  • Good written and verbal communication skills.

  • Ability to analyze and organize information logically.

  • Experience with troubleshooting, problem solving, risk assessment and mitigation.

  • With assistance from direct line manager, is able to make risk based recommendations based on science , data, or relevant experience.

  • Good communication, technical, and organizational skills are required.

  • Must be a team player prepared to work in and embrace a team-based culture.

Internal and External Contacts

Advises, consults and collaborates with cross-functional teams including but not limited to: Facilities and Engineering, Quality, Validation, Process Development and and Technical Support, and Health, Safety & Environment, Materials Management, Supply Chain, and Regulatory.

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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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.