Director, Biosafety of Biological Products and Raw Materials, BPD - Gaithersburg, United States - AstraZeneca

Description

AstraZeneca: Biologics Process Development Leader

Are you passionate about Science? Would you like to contribute your expertise to impact a company that focuses on science and transforms ideas into life-changing medicines? If so, AstraZeneca might be the perfect fit for you.

At AstraZeneca, our priority is always the patients, and we strive to meet their needs worldwide. Working here means aiming high, thinking big, and collaborating to turn the impossible into reality.

About AstraZeneca in Gaithersburg, MD:

Our Gaithersburg, Maryland facility is dedicated to creating life-changing medicines for people globally. This campus, situated just a short drive from Washington, DC, is home to over 3,500 experts in the field and serves as the hub for R&D and Oncology in the US.

One of the hallmarks of this modern and dynamic scientific campus is the cutting-edge technology and laboratory spaces designed to foster collaboration and interdisciplinary science.

At AstraZeneca, we believe in challenging and inspiring our employees at work, cultivating a culture of inclusivity and collaboration.

The Gaithersburg site offers various amenities to enhance productivity and promote employee well-being, including a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning services, full-service cafeteria, and copy center. The site also boasts newly-designed, activity-based workspaces tailored to different working styles, fostering team collaboration.

Summary of the group:

The Cell Culture and Fermentation Sciences (CCFS) group, part of BioPharmaceutical Development (BPD), is responsible for upstream process development activities across AstraZeneca's biologic product portfolio. This includes therapeutic proteins, cell therapies, viruses, mRNA, and vaccines. CCFS oversees cell line development, upstream process development, technology transfer, process validation, and regulatory submissions. The group is also at the forefront of implementing innovative technologies to advance AZ's biologics products.

Job Description:

AstraZeneca is seeking a dynamic leader for biologics process development focusing on Biosafety of Raw Materials, Starting Materials, Products, and Cell Lines. This role involves providing leadership for biosafety assessments, control strategies, compliance, and regulatory submissions related to biosafety. The ideal candidate will collaborate with various internal and external stakeholders to ensure biosafety requirements are met for all projects.

Responsibilities:

• Lead the development and implementation of safety strategies for biologic products in compliance with regulatory standards.
• Provide guidance to project teams to define appropriate safety strategies for global clinical studies and product approvals.
• Offer expertise in biosafety risk assessment for raw materials, cell banks, unprocessed bulks, and cell lines.
• Define testing requirements and control strategies for cell banks used in biological product manufacturing.
• Collaborate with internal teams to ensure analytical methods align with regulatory standards.
• Assess and ensure compliance of biosafety documentation for various projects.
• Lead project planning and author technical documentation for regulatory submissions.
• Oversee the development and implementation of new biosafety evaluation approaches.
• Provide leadership within the organization and industry on safety practices.

Education & Experience Requirements:

BS/MS/PhD in Biotechnology, Biochemistry, Cell or Molecular Biology, Virology, Immunology, or related fields. For Director role: BS with 15+ years, MS with 13+ years, or PhD with 8+ years of industry experience.

Required Skills:

• Demonstrated experience in leading safety strategies for biologic products.
• Experience in preparing regulatory documents related to biosafety.
• Ability to address inquiries from health authorities.
• Knowledge of safety testing guidelines and standards.
• Experience in team leadership and project management.
• Strong communication and interpersonal skills.

Desired Skills:

• Experience with biosafety assessment for gene and cell therapy products and viral vaccines.
• Familiarity with innovative biosafety testing approaches.

Why AstraZeneca?

AstraZeneca is committed to seizing opportunities for change and delivering life-changing medicines. Join us in reshaping the biopharmaceutical industry, redefining work methods, and driving innovation through collaboration.

If you are ready to contribute fresh ideas and be part of a transformative journey, seize the available opportunity at AstraZeneca and be a part of the change.

For more information about this role, visit AstraZeneca's official website.