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Director, Manufacturing Science and Technology
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Director, Manufacturing Science and Technology : MedImmune, LLC.
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| Job Number |
02269 |
| Employee Type |
Full Time |
| Company Name |
MedImmune, LLC. |
| Location |
Philadelphia
Pennsylvania
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| Salary (year) |
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| Start Date |
3/1/2010 |
| Industry |
Biotech |
| Job Type |
Manufacturing |
| Relocation |
Not Required |
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MedImmune, LLC.
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| Description |
Description
Title: Director, Manufacturing Science and Technology
Location: PA, Philadelphia - Non-Sales
Req: 02269
Position Summary:
• To provide vision and leadership to the Manufacturing Science and Technology Department, proactively managing the growth and technical expertise of the function and continued process improvement. To manage and lead the Manufacturing Science and Technology Department to ensure it provides technical support to maintain/improve quality, compliance and operational efficiency by assisting in resolving process problems, optimising production and analytical operations, implementing new equipment, transferring processes from development and generating appropriate documentation, where required. As part of the PA Site Leadership Team, the Director plays a key contributing role in defining the values, culture, goals and growth of the site.
About the Organization
My company shares my
passion for helping to improve human health around the world."
"This is My MedImmune."
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc.
Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.
Company Information
MedImmune, LLC. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
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| Requirements |
Position Requirements
Major Duties and Responsibilities:
• Provide leadership, direction and mentoring to ensure Manufacturing Science and Technology Department alignment and delivery of department objectives and functional compliance standards.
• Develop vision and strategy for Manufacturing Science and Technology function focussing on the continued upgrade of the function and development of key personnel for purpose of succession.
• To oversee the implementation of key site projects, ensuring Project Sponsors are fully aware of the status, that requirements are aligned to the site objectives and that the projects are completed within the timeframe and cost, consistent with Regulatory Planning horizon
• Collaboratively work with Site Leadership team and corporate functions to achieve strategic product supply requirement and to contribute to the strategic objectives of the site
• To ensure that the department provides the appropriate level of technical support to maintain cGMP and production efficiency by assisting in the resolution of production and analytical problems, by optimising operations and process efficiency improvements via Operational Excellence tools and techniques.
• Lead investigation in complex manufacturing/testing deviations to comply with regulatory expectations and company policies and procedures.
• To oversee the transfer of processes from process development and generate the appropriate technology transfer documentation, where required.
• To ensure site VMP are up-to-date and compliant with regulatory requirements. Ensure validation and re-validation work is completed on time to meet quality and compliance expectations and production schedule
• To ensure the Quality Systems metrics associated with Manufacturing Science and Technology activities are maintained and improved within agreed limits according to the site key performance indicators
• Ensure Manufacturing Science and Technology function provides training and underpinning knowledge training on the site to improve process knowledge and understanding of the manufacturing operations.
• Participate in Regulatory Inspections (MHRA,FDA)
• Provides development opportunities for staff through the use of coaching, mentoring, performance management and Personal Learning Plans.
Educational Requirements
Requirements / Qualifications:
Education:
• Ideally to have a Post graduate qualification but have a minimum of science degree or equivalent in Biochemistry, Microbiology, Virology, Biochemical Engineering or other science field
Experience:
• It would be desirable for the job holder to have held a similar position
• > 15 years practical scientific experience.
• > 10 years in a multi-discipline cGMP environment preferably in the biopharmaceutical industry.
Skills and Knowledge Required:
• Demonstrated Leadership skills to work in matrix organization across different functions and sites
• Extensive scientific knowledge and skills and recognized expert in the area of validation, process development and technology transfer, quality by design (QbD) in biopharmaceutical and vaccine industry.
• Experienced in change management and total quality management approaches in biopharmaceutical industry
• Strong Project Management Skills
• Expertise in business process & systems development.
• Strong communication skills
• Ability to critically interpret analytical data is essential
• Knowledge of engineering terminology and requirements in regards to equipment together with strong technical report writing skills and excellent communication skills.
Job Complexity:
• High level of complexity, working on multiple priorities and at multiple levels of the company. The position is critical to the organisation as this individual is responsible for the Manufacturing Operation.
Supervision:
• Must work with minimal supervision and guidance, with a high level of independence and influence in terms of daily management of department, will receive broad direction from supervisor on strategic approach.
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