Production Technical Support Manufacturing - Assoc Director
Cambridge , Massachusetts
February 03, 2017
Primary Role:

The AD of PTS Floor Support is responsible for leading the group to provide floor support to internal drug substance manufacturing operations in Alewife plant of Lexington site. The key support services, deliverables, and capabilities within this function include:

• Daily process monitoring, incident response and containment
• Technical coaching/training for the plant
• SME support to deviation investigation
• SME support to tech transfer
• Ownership of effectiveness check
• Lead the implementation and improvement of Standard Work system
• Drive the alignment of the Floor Support activities across plants
• Act as a liason between manufacturing and other Center function areas

The AD is responsible for driving the organization towards a culture of safety, innovation, collaboration, best practice, accountability, and efficiency. The primary objective is to ensure manufacturing processes are operated as designed and validated.

Process Monitoring - Troubleshooting, Identify and overcome barriers to ensure product quality.
• Monitor upstream and downstream production process performance.
• Provide support to floor operations, protocol execution, and training of manufacturing staff.
• Troubleshoot process deviations to understand the possible causes from a scientific perspective.

Manage and Develop Staff- Through direct supervision and in terms of project coordination, resource allocation, and methodologies.
• Motivate and support the career development and technical expertise of reports, and communicate company policies/goals/strategies/business results.
• Anticipate resource requirements, delegate appropriately, and assure reports are productive and work is focused.
• Engages in proactive measure to promote and foster a positive safety culture to ensure zero incidents, injuries, and the protection of people, property and the environment through communications, review of EHS performance metrics and incident reports.
• Champion self-initiated projects and drive area under their control within the context of functional area priorities.
• Effectively communicate ideas, project goals, and results.
• Foster teamwork and drive project/process improvement.
• Expected to lead cross-functional projects and teams.

SME Support - Provide SME support in the following areas:
• Continuous improvement project
• Facility fit for tech transfer
• Batch records/SOP review
• Floor support during production runs

Work System Support - Support the implementation and improvement of the Work System at Lexington manufacturing site

Technical Training Program Development - develop an effective technical training program to improve the technical capability of team member and other function groups

Education & Experience Requirements:
• BS/MS Degree in Science or Engineering with 10+ years of relevant experiences.
• Proven record of technical leadership in both upstream and downstream process areas, including ability to influence, motivate, and drive technical rigor.
• Proven record of a strong team leader, coached and developed a collaborative team.

About Shire:
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.

Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
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Pay Transparency Policy

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.

A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.

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