Manager, Late Stage 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.

We have an exciting opportunity for a Manager in our Late-Stage Process Development Department in Copenhagen. We’re looking for a colleague with experience in people management within the biopharmaceutical field, who possesses strong collaboration skills both within and across departments.

About the Job

AGC Biologics is experiencing significant growth, with an increasing number of customers and projects—many of which are in late-stage development and preparing for commercial launch. We are also involved in new and exciting customer projects while supporting ongoing clinical and commercial supply processes at our facility. Given our expanding activities, we’re seeking a new colleague with leadership experience in the biopharmaceutical field.

About the Department

Our Late-Stage Process Development Department currently comprises around 40 team members across three teams. Each team includes upstream, downstream, and analytical development scientists and technicians who work with other departments to bring new biopharmaceuticals closer to market. Our department fosters an informal work environment that promotes continuous collaboration throughout the organization, with all team members maintaining a professional and flexible approach to their work.

About the Role

You will manage a team of around 12 members responsible for late-stage processes, including robustness studies, scale-down model qualifications, process characterization, viral clearance studies, and providing analytical support. The team is also responsible for cell banks, GMP working cell banks (WCBs), and limit of in vitro cell age (LIVCAs) or end –of production (EOP) cell banks.

Your primary responsibility will be to lead and support team members while ensuring efficient department operations. You will work closely with other managers to oversee daily activities and report directly to the department head. This role also involves creating a positive, motivating, and productive work environment aligned with AGC Biologics’ values. You will conduct team performance evaluations and set individual goals.

Your Primary Tasks Will Be…

• Leading a team of scientists and technicians.

• Monitoring team members’ participation, engagement, and performance to foster effective collaboration.

• Providing constructive feedback to team members and facilitating open communication.

• Ensuring compliance with company policies, procedures, internal and external quality standards, and regulatory requirements.

• Effectively managing daily operations and balancing workloads across multiple projects.

• Representing the department professionally, ensuring smooth interactions with internal and external stakeholders.

• Supporting the team on customer and internal projects as needed.

This position offers opportunities to interact with a variety of stakeholders across the organization and with clients. You will engage with biopharmaceutical companies globally and actively participate in their projects, with each day presenting new challenges.

Your Qualifications…

• Relevant educational background in fields such as biochemistry or process technology.

• Proven experience in team management within the biopharmaceutical sector.

• Experience leading both scientists and lab technicians is highly advantageous.

• Ability to assist the team in planning, executing, and reporting on late-stage studies.

• Experience in process development, especially in late-stage programs, is preferred.

• Experience presenting in audits/inspections and preparing regulatory documentation is a plus.

• Flexibility and a willingness to take on new tasks and responsibilities.

• Strong interpersonal and communication skills for effective interaction with internal and external stakeholders.

• Capability to manage multiple projects simultaneously.

• Fluency in English, both written and spoken.

Are you up for the challenge?

• To apply, please submit your CV. We encourage you to apply even if you do not meet every requirement.

• If we see a potential match, one of our recruiters will contact you to discuss your application.

• If both sides remain positive after this discussion, we will proceed to the assessment stage to evaluate the key skills required for the job.

• For further information, please contact Lígia Gomes, Director of Late-Stage Process Development, at [email protected].

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.
Location: Copenhagen Site