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Director/Senior Director, Development Manufacturing Sciences
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Director/Senior Director, Development Manufacturing Sciences : MedImmune, LLC.
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| Job Number |
02201 |
| Employee Type |
Full Time |
| Company Name |
MedImmune, LLC. |
| Location |
Gaithersburg
Maryland
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| Salary (year) |
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| Start Date |
2/9/2010 |
| Industry |
Biotech |
| Job Type |
Development-Manufacturing-Sciences |
| Relocation |
Not Required |
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| Description |
Description
Title: Director/Senior Director, Development Manufacturing Sciences
Location: MD, Gaithersburg - Corporate Headquarters
Req: 02201
Major Duties and Responsibilities (including supervising others):
• Responsible for the operation of the Gaithersburg Pilot Facility manufacturing clinical trial material under cGMP compliance.
• Lead 3 - 4 managers/associate directors. Supervise, plan and direct clinical manufacturing operation and schedules for cell culture, purification or support services
• Develop, implement, monitor, and create monthly and yearly goals and schedules
• Design, develop, implement and ensure adherence to cGMP compliance
• Develop and oversee the administration of a budget that includes equipment, materials, and staffing
• Ensure that all operations are performed with 100% compliance to cGMP standards.
• Ensure maintenance of a safe manufacturing work environment that complies with company and state regulations
• Routinely communicate a compelling vision and sense of purpose for the clinical production group.
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
Experience:
Director Level: BS or MS with a minimum of 20 years experience in large scale GMP clinical or commercial manufacturing is required. Ph.D. with 12+ years of biotechnology industrial experience is preferred.
Minimum 3 years of direct supervision experience in a mammalian or microbial manufacturing facility. Graduate-level coursework including management training a plus. A working knowledge of safety, quality systems and quality assurance concepts is required including the application of current cGMPs. Experience in cell culture process development, and / or downstream operations and other supporting functions, a plus.
Sr. Director Level: BS or MS with a minimum of 20 years experience in large scale GMP clinical or commercial manufacturing is required. Ph.D. with 15+ years of biotechnology industrial experience is preferred.
Minimum 5 years of direct supervision experience in a mammalian or microbial manufacturing facility. Graduate-level coursework including management training a plus. A working knowledge of safety, quality systems and quality assurance concepts is required including the application of current cGMPs. Experience in cell culture process development, and / or downstream operations and other supporting functions, a plus.
Special Skills/Abilities: Provide Leadership to group, with a focus on verbal and written communication, teamwork and problem solving. Interact with other departments including QA, QC, Facilities, Engineering, Validation, Metrology, and other functional areas within Development. Identify employee training and developmental needs and effectively mentor, support and counsel staff to ensure optimal performance, productivity, and competency. This includes adhering to HR policies and procedures. Assist senior management with setting business goals and cross functional deliverables. Identify and implement continuous improvement opportunities. Proactively determine department needs and communicate these to support groups. Generate periodic updates and prepare formal presentations for required forums.
Job Complexity: The job is complex, requiring a thorough understanding of cell culture and / or purification operations, clinical manufacturing, and personnel management. Erroneous decisions or recommendations would normally result in critical delays and modifications to projects or operations; cause substantial expenditure of time, human resources, and funds; and jeopardize future business activity.
Supervision: Accomplishes results through subordinate supervisors or managers, and junior level exempt and non-exempt employees. Subject to approval, modifies the organizational structure of centralized functions and units. Responsible for managing an operational group within the clinical manufacturing arm of Development. Receives general guidance on key objectives.
Educational Requirements
Requirements/Qualifications:
Education: Requires a BS, MS, or PhD in Biochemistry, Chemical Engineering or other relevant discipline plus relevant industrial experience in bioprocessing for therapeutic protein products or equivalent.
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