Biologics Operations Submission Manager- Gaithersburg, MD

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe.

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC.

The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams. Come and thrive in our vibrant, energizing, connected and encouraging culture and make a difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

In the Biologics Global Technical Operations (GTO), we work closely with AstraZeneca’s manufacturing network of internal sites and external manufacturing partners (CMOs), our colleagues in R&D, Quality, Regulatory, Supply Chain, and Commercial to provide technical leadership to ensure delivery of quality products to our patients and support our product pipeline. The Biologics Operations Submission Manager (BioOps SM) will work within GTO, Biopharmaceutical Development and Biologics Operations scientists, managing the preparation and review process of regulatory documents for the quality (CMC) modules. As a member of the SM team, you will coordinate and consult on regulatory filings and writing processes; identify and promote initiatives to advance the AstraZeneca biologics pipeline and support marketed products.

Main Responsibilities:

• Responsible for BLA/MAA delivery and life cycle management of regulatory submission documents working within Global Technical Operations.
• Lead or participate in cross-functional teams as the BioOps SM representative to provide submission related expertise.
• Lead the process of critical review of CMC regulatory documents and incorporating multiple internal and external reviews into quality documents.
• Manage SM activities associated with multiple projects: delivery of documents to submission ready standards.
• Participate or lead template and procedure preparations.
• Participate in SM-related workstreams within and across departments.
• Assists in providing ANGEL business support and training to Biologics Operations network
• Lead or participate in process improvement initiatives.
• Work with Reg CMC, BPD Submission Management and the GTO Product Champion to ensure seamless transfer of submission management responsibilities for post approval submissions and Wave 2+ markets.

Minimum Requirements:

• Bachelor’s Degree. Biology, Biochemistry, Chemistry, Engineering or related field preferred.
  • Minimum of seven (7) years’ experience in biopharmaceutical development relevant to manufacturing and drug development of biologics products, such as cell culture, purification, analytical biochemistry, formulation, device, etc.

• Master’s Degree. Biology, Biochemistry, Chemistry, Engineering or related field preferred.
  • Minimum of four (4) years’ experience in biopharmaceutical development relevant to manufacturing and drug development of biologics products, such as cell culture, purification, analytical biochemistry, formulation, device, etc
• At least one (1) year of writing experience in a regulatory environment strongly preferred.
• Experience preparing CMC regulatory documents and/or manuscripts is desirable.
• Background in biologics such as monoclonal antibodies and/or vaccines.
• Must have strong interpersonal skills and an ability to influence.
• Must be able to work on multiple projects at once.
• Must be proficient in Microsoft Office.
• Knowledge and understanding of FDA and EMA regulatory requirements and ICH guidelines.
• Experience in working with Style guides and electronic submission systems.
• Project management experience and a high level of organizational skills.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

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About Operations https://www.youtube.com/watch?v=gak5Ham8oUw

Date Posted

12-Feb-2024

Closing Date

22-Feb-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.