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Associate Director Quality Control
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Associate Director Quality Control : MedImmune, LLC.
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| Job Number |
01962 |
| Employee Type |
Full Time |
| Company Name |
MedImmune, LLC. |
| Location |
Santa Clara
California
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| Salary (year) |
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| Start Date |
1/18/2010 |
| Industry |
Biotech |
| Job Type |
Operations-Quality |
| Relocation |
Not Required |
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MedImmune, LLC.
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| Description |
Description
Title: Associate Director/Senior Manager - Quality Control
Location: CA, Santa Clara - NON SALES
Req: 01962
Position Summary:
The job holder is responsible for the management of daily operations within the Virology and Analytical testing laboratories in the Quality Control department at the MedImmune-California site, performing cell based bioassays, vaccine virus characterization, and analytical chemistry for the testing of drug substance, drug product and stability samples in support of commercial and clinical product release.
Major Duties and Responsibilities (including supervising others):
• To lead multiple Quality Control laboratory groups in the Virology and Analytical laboratories, providing operational quality support (cGMP product testing and stability) within the CA, and other MedImmune sites, as appropriate.
• To ensure via planning, delegation and resource management the timely, effective and compliant output of the laboratories to meet customer and regulatory requirements.
• To develop a motivated, informed and efficient workforce through training, mentoring, sharing of critical underpinning knowledge and other initiatives.
• To provide expert review of virological, biological and analytical chemical methods, equipment specifications and subjects as required meeting the relevant regulatory and legislation requirements.
• To liaise with the analytical development groups and to provide technical support to continue to provide efficient and effective assay performance, which will include analytical and biological safety assay method development / technical transfer, analytical method validation activities, and assay troubleshooting.
• To actively encourage continuous improvement and operation excellence in working practices and procedures throughout the department.
• To monitor the laboratory systems through performance metrics
• To participate in Company inter-departmental problem-solving and teamwork initiatives.
• To monitor and technically support the company procedures monitoring excursions and investigations
• To support and perform, where applicable, internal and external quality audits.
• To promote good company relations with external parties to ensure the provision of a quality and efficient contract services.
• Work with QC Director and senior management to develop budget and efficiently manage laboratory operation to operation within budget constraints.
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
Special Skills/Abilities:
• Must be technically competent in virology and have working knowledge of analytical chemistry methods (FTIR, HPLC,GC etc)
• Must be well versed in cGMP, CFR, EP and ICH requirements related to QC and manufacturing
• Must be able to utilize effective decision making techniques
• Must have experience of using investigational tools and techniques (Root Cause analysis, Fact gathering etc)
• Supervisory experience is essential
• Must Possess excellent communication skills, ability to interact at multiple levels within the organization with proven knowledge transfer.
• Should have good knowledge of statistics, particularly as applied to biological assays and stability.
• Regulatory Inspection experience is desirable
Job Complexity:
High level of complexity, working on multiple priorities and at multiple levels within and outside the company. Position is critical to the organization as the individual is responsible for the QC of company’s influenza vaccine and other commercial and clinical products.
Supervision:
Moderate supervision is required for the position. Individual will have a high level of decision independence and influence in terms of daily management of department, will receive broad direction from Director and senior Quality management on projects and strategic approach
Educational Requirements
Education:
Minimum of a BS/MS degree or equivalent, Ph.D. would be favorable in a biological discipline to include one or more of the following - virology, cell biology, Immunology, Molecular Biology, biotechnology, bio-safety.
Experience:
• Minimum of 10 years experience working in a scientific post in Research, Development or Industrial setting plus
• Minimum of 8 – 10 years of experience in biopharmaceutical quality control testing, with a focus on cGMP is essential.
• Also, the proven ability to successfully demonstrate increasing levels of management responsibility, preferably in a commercial manufacturing or Contract Testing setting together with minimum of 5 year’s experience in managing and / or supervision of a biological or chemical testing laboratory.
• The jobholder should have a wide knowledge of the biological (in vivo and in vitro methods), biochemical and analytical testing methods available, as applied to biologics. A strong background in Virology is essential. The candidate should be conversant in understanding the CFR, USP and the European Pharmacopoeias, and be knowledgeable of relevant industry standards.
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