Shire Sr PTS Operations Project Manager ABP in Cambridge, Massachusetts

Primary Role:

The Sr. Project Manager will own and lead projects of various complexities which include the implementation of process, product, and operational change controls and corrective / preventative actions resulting from investigational findings and/or audit commitments, and participate on cross-functional teams to support manufacturing.

Responsibilities:

60%:

Actively own and manage CAPA and Change Controls (initiation through closure) as they relate to Manufacturing operation and process changes. This includes development, execution, implementation, closure, and oversight of process related projects and quality systems through effective use of project management.

• Demonstrates knowledge in bridging technical and business disciplines to drive implementation of effective solutions for the MFG function.

• Obtains agreement on project definition, scope and priorities. Ensures that resources, capabilities and processes are in place for proper project execution, sponsorship and governance.

• Leads the planning and implementation of assigned projects and by resolving conflicts and removing obstacles through the proper use of escalation

• Reports project status including project progress, risks / problems and solutions

• Ensures that appropriate risk management analyses are performed and mitigation plans are in place for project implementations

• Applies efficient work practices for project management and ensures continual improvement of practices with the use of lessons learned ensures they stay on track and are implemented / closed on time

20%:

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, Materials Management, QC, etc…)

• Facilitate, lead and/or participate on risk assessment and options analysis teams

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

20%:

Perform base business activties:

• 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 efficienciency intitiatives)

• Participate in regulatory and internal audits including direct interaction with inspectors for CAPA or CC records, scribe duties, facilitation of audit requests, and development of responses.

Education & Experience Requirements:

Bachelor’s degree or equivalent experience in Engineering or Science and 5 plus (5+) years of relevant experience in commercial biotechnology or pharmaceutical production.

Prior experience managing projects and schedule development is required. Working knowledge of project controls in cost and financial assessments is desirable. PMP or comparable certification and direct management experience is preferred.

• Strong knowledge of cGMPs and applicability to manufacturing operations is required

Knowledge of Quality by Design (QbD), Quality Risk Management (QRM) Good Engineering practices (GEP) and PM practices.

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.