Principal Scientist, Biosafety of Biological Products and Raw Materials, BPD

Gaithersburg, MD

Employer:	AstraZeneca
Job Type:	Full Time
Description
Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being high-reaching, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person. About AstraZeneca in Gaithersburg, MD: Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 authorities in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most ground breaking technology and lab spaces, all crafted to encourage collaboration and cross-functional science. We believe employees benefit from being challenged and encouraged at work. We are dedicated to crafting a culture of inclusion and collaboration. The Gaithersburg site offers a variety of amenities to help boost efficiency 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 growing collaboration between teams. Summary of the group: The Cell Culture and Fermentation Sciences (CCFS) group is part of BioPharmaceutical Development (BPD) and is responsible for upstream process development activities across the lifecycle of all biologic products in AstraZeneca's (AZ) portfolio, from early stage to initial commercial registration and post marketing process changes. Products include therapeutic proteins, cell therapies, viruses, mRNA, and vaccines. CCFS is responsible for cell line development, upstream process development, technology transfer, process validation, technical support for manufacturing, and preparation of CMC documentation for regulatory submissions. CCFS is also responsible for developing and implementing novel technologies, including intensified production processes, automation, high-throughput approaches, and digitalization to support the advancement of AZ's extensive portfolio of biologics products. Job Description: AstraZeneca is seeking a highly motivated leader for biologics process development with a focus on Biosafety of Raw Materials, Starting Materials (e.g. cell banks, virus seeds), Products, and Cell Lines. This position provides line function and cross-functional matrix leadership for the assessment, control strategy, and compliance of biosafety for all starting materials and cell lines used in the GMP production of biologic products in AZ's portfolio. The successful candidate will also be responsible for the strategy and content of the biosafety sections in regulatory submissions (INDs/BLAs) as well as ensuring availability of all supporting documentation. The incumbent will work closely with the process development groups located in the US and UK, regulatory affairs, quality, technical writing, and external vendors and suppliers to ensure that all materials meet biosafety requirements and that appropriate risk mitigation strategies are in place for all projects. Responsibilities: Responsible for leading development and implementation of Virus, Microbial, and TSE safety strategies for all biologic products in AZ's pipeline to meet evolving regulatory requirements. Provides guidance and leadership to CMC project teams to define appropriate product-specific Virus, Microbial, and TSE control strategies to support successful global clinical studies, product registration and approvals. Provides subject matter expertise and leadership for biosafety risk assessment of raw materials, starting materials (cell banks, virus seeds, etc.), unprocessed bulks, end of production cell banks (EOPCB), limit of in vitro cell age (LIVCA) banks and cell lines, based on requirements for each product modality. Responsible for defining the testing requirements and control strategy for the preparation of cell banks used to produce biological products including host cell lines, therapeutic proteins, mRNA, cell therapies, and viruses. Provides skilled expertise for biosafety testing of raw materials, starting materials unprocessed bulks as part of a cross-functional team. Ensures compliances with regulatory guidance and pharmacopoeia requirements specific to the type of product being manufactured. Works collaboratively with the Analytical Development team to ensure that analytical methods used for virus and microbial safety are appropriate and meet current regulatory requirements. Completes assessment of biosafety documentation and control strategy for in-licensed projects and third-party manufacturing processes. Defines strategy to close gaps in documentation, testing requirements, and risk assessments to ensure compliance with regulatory guidance. Leads portfolio project planning for timely scheduling of cell line testing, report writing, and documentation to support manufacturing schedules. Authors, reviews, and approves technical documentation, risk assessments, biosafety sections of regulatory submissions (INDs/BLAs), and responses to questions from health authorities Procures, reviews, and maintains relevant source documentation for regulatory submissions associated with biosafety of materials and cell lines used for product manufacturing. Leads/supports development and implementation of new material biosafety evaluation approaches for clinical and commercial manufacturing. Provides leadership within AZ and across industry on the development and implementation of novel approaches to ensure Virus, Microbial, and TSE safety. Serves as Skilled Specialist in interactions with health authorities Brings technical expertise to the understanding and impact of raw materials to process performance and product quality. Acts as a key collaborator with Quality, Regulatory Affairs, Scientific Writing, and Operations regarding biosafety of raw materials, starting materials, cell lines, and products. Maintains and applies subject-matter knowledge on CMC regulatory guidance, CMC documentation practices and CMC authoring tools. Serves as skilled specialist for due diligence assessments. Responsible for matrix and direct line management of employees supporting this function. Builds and develops dedication teams as well as recruits and develops technical leaders within CCFS. Education & Experience Requirements: BS/MS/PhD in Biotechnology, Biochemistry, Cell or Molecular Biology, Virology, Immunology, Biological Sciences or a related team. For Director: BS with 15+ years, or MS with 13+ years, or PhD with 8+ years of relevant industry experience. Required Skills: Demonstrated experience in leading Virus, Microbial, and TSE safety strategies for therapeutic protein products in early and late-stage development as well as for commercial registration. Demonstrated experience in preparing CMC sections of regulatory documents and technical reports pertaining to biosafety of raw materials, cell banks, and therapeutic protein products for clinical studies and commercial registration. Experience in addressing inquiries from health authorities and effectively working within multi-functional teams to defend company position on biosafety strategy. Excellence in preparing and defending biosafety strategy and risk assessments for raw materials, starting materials and cell lines. Knowledge of adventitious agent safety testing (viruses, microbes, prions) and relevant guidelines (e.g. ICH, regional health authority guidance, PDMA, WHO) as well as pharmacopeial standards concerning biosafety testing and risk assessments. Experience in working with electronic document management systems using good organizational skills. Demonstrated ability to lead a team responsible for multiple project activities and ability to set the proper priorities to ex-implement them effectively. Demonstrated ability to lead technical line functions and matrix teams Knowledge of GMP manufacturing principles and documentation Confirmed critical thinking skills Excellent written and verbal communication skills Strong interpersonal skills and demonstrated ability to effectively work across a large organization Desired Skills: Experience with biosafety assessment of raw materials, viruses, and cell lines used for gene and cell therapy products, including preparation of regulatory filings and responses to questions from health authorities. Experience with biosafety assessment for viral vaccines. Familiarity with new approaches (e.g. next generation sequencing) for biosafety testing and considerations for implementing these new approaches versus current compendial methods Why AstraZeneca? At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being bold - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey. So, what's next! Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours. Where can I find out more? Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/ Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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Principal Scientist, Biosafety of Biological Products and Raw Materials, BPD

Gaithersburg, MD

Description