Senior Scientist, Cell Banking and Upstream Process Development

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Are you ready to play a pivotal role in the foundation of biopharmaceutical manufacturing? We are seeking a specialist to govern and coordinate our critical cell banking activities, bridging scientific process with GMP compliance and helping to turn breakthrough ideas into life-changing medicines.

Join a fast-growing, global CDMO where your unique blend of expertise in cell banking, regulatory standards, and upstream processes will drive innovation and accelerate our customers’ biologics from concept to clinic.

ABOUT AGC BIOLOGICS

At AGC Biologics, we are a global leader in biopharmaceutical contract development and manufacturing, offering high-quality solutions for protein-based therapeutics, gene therapies, and other advanced biologics. We partner with biotech and pharmaceutical companies of all sizes to provide tailored solutions across the entire product lifecycle. Our commitment to innovation, technical expertise, and client success drives us to deliver results that make a difference in patients’ lives.

THE DEPARTMENT AND TEAM

The Early-Stage Process Development Department (ESD) plays a crucial role in bringing new drugs from concepts to patients, with projects ranging from early pre-clinical development through clinical studies. The department is responsible for cell line development, early-stage process development, and cell bank manufacturing.

The department is composed by three interdisciplinary teams, where upstream, downstream and analytical experts work together to achieve the project goals. You will be part of a group of highly dedicated laboratory technicians and scientists collaborating on development and optimization of processes. The teams are driving the projects, and you will experience close collaboration within the team between different technical disciplines. We develop processes for products produced in both mammalian and microbial cell lines and collaborate with various stakeholders such as Analytical Method Development and Manufacturing. You will experience a dynamic and flexible working place with many opportunities to both contribute and develop.

THE ROLE

As a Principal/Senior Scientist, you will be the central point of expertise for our cell banking operations. Your primary focus will be on the coordination, oversight, and compliance of our cell banking facilities and activities. You will act as a key liaison between internal teams, external partners, clients, and regulatory authorities.

Your expertise in upstream development will be highly valued, as you will also have the opportunity to support our classical upstream process development projects, making this a unique and versatile position.

This position offers the opportunity to work on cutting-edge technologies, mentor junior colleagues, and drive innovation in a fast-paced, project-driven environment.

KEY RESPONSIBILITIES:

• Act as the subject matter expert (SME) for our cell banking facilities and activities, providing critical support during audits and inspections by customers and health authorities.

• Coordinate all cell bank production and characterization campaigns, both for in-house activities and those outsourced to external partners.

• Manage the full logistics lifecycle of cell banks, including coordinating their secure receival, storage, and shipment to clients and manufacturing sites.

• Support the formal release of cell banks, ensuring all documentation and characterization data meets stringent quality and regulatory standards.

• Contribute your expertise to classical upstream development projects, including the design and execution of experiments for process optimization and scale-up of upstream processes for mammalian cell lines, from shake flasks to pilot-scale bioreactors.

• Prepare and review technical protocols, campaign summary reports, and other key documents to support project milestones and regulatory filings.

• Handle deviations, CAPAs, and CRs, as well as update of SOPs.

Preferred qualifications:

Furthermore, the ideal candidate would also have:

• Hands-on experience with upstream process development (e.g. mammalian cell culture, bioreactor operation, process optimization)

• Experience with vendor and CMO/CRO management.

• Familiarity with data analysis tools (e.g. SAS JMP).

On a personal level we expect you to be a high-performing team player and to be ambitious on behalf of yourself and the company. You master the balance between speed of execution and quality of work. You embrace change and enjoy a rapid pace of work in a positive, can-do attitude and with a good sense of humor. You are experienced with working cross-functionally and internationally.

APPLICATION AND CONTACT
We screen applications on a rolling basis—please apply as soon as possible. For more information, please contact Hiring Manager, Anas Al-Khawaja, by phone: 2610 8328.

Join an international and agile organization At AGC, you will get great opportunities to work with a wide array of tasks and challenges, and you will get experience with our various departments. Furthermore, as we plan projects and tasks together in the team, you will get the opportunity to influence your daily work. AGC offers an informal working environment where high energy and enthusiasm is part of the daily work life. We respect each other and our individual differences. At AGC, we have a flexible attitude, and we help each other reach deadlines as a team.

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.