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Senior Manager / Associate Director, CMC Regulatory Affairs
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Senior Manager / Associate Director, CMC Regulatory Affairs : MedImmune, LLC.
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| Job Number |
02181 |
| Employee Type |
Full Time |
| Company Name |
MedImmune, LLC. |
| Location |
Gaithersburg
Maryland
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| Salary (year) |
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| Start Date |
1/18/2010 |
| Industry |
Biotech |
| Job Type |
Regulatory-Affairs |
| Relocation |
Not Required |
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MedImmune, LLC.
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| Description |
Description
Title: Senior Manager / Associate Director, CMC Regulatory Affairs
Location: MD, Gaithersburg - Corporate Headquarters
Req: 02181
Position Summary:
This position will provide CMC regulatory strategy development and implementation plans that incorporates risk identification and contingency planning for assigned pre and/or post-approval biotechnology based programs at MedImmune’s licensed manufacturing facility in Frederick, Maryland (FMC). He/she will act as the main regulatory affairs contact for facility personnel regarding implications of anticipated changes as well as process deviations which may occur. This position will also participate in change control decisions. Position will also be MedImmune’s key regulatory contact with external clients to support their investigational and marketing applications for products manufactured at FMC including interactions as requested with FDA and/or other Regulatory Agencies to support CMC activities. Actively partner with Manufacturing Operations, Quality Assurance (QA) and other functional areas to establish alignment with the facility and product regulatory strategies and to communicate facility regulatory CMC requirements to team members both internally and externally.
1. Partner with FMC Manufacturing and QA to provide regulatory support to both MedImmune programs as well as clients and manufacturing partners for a variety of monoclonal antibody and therapeutic protein programs.
2. Liaise within Manufacturing, Quality Assurance and other relevant groups to ensure high quality, submission ready facility and CMC documentation is developed.
3. Participate in risk assessments and identify appropriate strategies to manage regulatory risk of planned product and facility changes.
4. Responsible for the development of facility related documents for IND/IMPD/CTA, and CTD submissions for external clients as requested, ensuring that they meet current regulatory standards, are high quality, consistent, complete, and approvable during the first review cycle.
5. Act as the main regulatory point of contact for facility and QA personnel regarding change control. Effectively triage the change control documents to RA product leads.
6. Participate and/or lead various multi-disciplinary teams or taskforces related to the FMC facility and CMO activities.
7. Participate in communications with FDA or other Regulatory Agencies as requested by clients.
8. Participate as a member of technology transfer teams.
9. Provide support to QA and external clients for Regulatory Agency inspections.
10. Proactively identifies issues early and recommends and/or negotiates solutions.
11. Educate internal and external stakeholders on the intent and implications of applicable regulations and guidance.
12. Attend and participate in applicable CMC-related conferences to drive MedImmune initiated policies and to maintain up-to-date knowledge of industry standards and regulatory authority expectations.
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/Affirmative Action 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
A minimum of 8-10 years of increasing documented success in biopharmaceutical field, with at least 5 of those years in regulatory affairs biotechnology CMC. Strong background in cGMPs, facilities and post-marketing submissions. Experience with monoclonal antibody manufacturing and regulations highly preferred.
Special Skills/Abilities:
1. Self-motivated/pro-active and strategic thinker
2. Proven track record in biotechnology CMC regulatory affairs
3. Proven management skills
4. Effective in a highly matrixed organization and able to manage external business partners
5. Comfort interacting with senior staff
6. Excellent oral and written communication skills
7. Strong interpersonal /group skills
8. High standard of professional ethics, integrity, and trust
9. Ability to interpret, understand and effectively communicate all relevant FDA, ICH, RoW regulatory CMC requirements both internally and to external clients
10. Operate independently
Job Complexity:
Strong understanding of regulations and guidance governing the manufacture, testing, and release of biotechnology products, especially monoclonal antibodies, in both pre-approval and post-approval situations.
Must be able to quickly assimilate information and be flexible with change; must be skilled at identifying issues early along with recommending and negotiating potential solutions.
Travel: Approximately 10-15% travel; some international travel may be required. Position will be co-located between the Frederick and Gaithersburg facilities, which are approximately 20 miles apart.
Educational Requirements
Education: An advanced degree in the life sciences, chemistry or appropriate engineering discipline is required.
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