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.
An exciting and diverse career opportunity awaits you in our Process Transfer & Validation Department in Copenhagen. We are actively seeking a quality-focused individual with expertise in downstream processing and a proven ability to foster interdepartmental collaboration. Join us in shaping the future of biopharmaceutical development and manufacturing!
The Team
The Process Transfer & Validation (PT&V) Department consists of three specialized teams: Early-Stage Process Transfer and Validation, Late-Stage Process Transfer and Validation and Material Science.
About the Role
AGC Biologics is seeking a talented and experienced Downstream Process Transfer Scientist to join our dynamic department under MSAT unit. In this role, you will play a key part in the successful transfer of downstream processes from development to manufacturing or form our clients into AGC Biologics manufacturing, ensuring seamless integration and optimal production.

Depending on your level of qualification, you will take part in key downstream process activities in several projects, both within microbial and mammalian processing. As a Process Transfer Scientist in the Early Stage Team, your key responsibilities will include:

• Collaborating with cross-functional teams to facilitate the smooth transfer of downstream processes from development to manufacturing.
• Leading and executing technology transfer tasks, ensuring alignment with project timelines and stringent quality standards.
• Offering technical proficiency in downstream bioprocessing, encompassing process scale-up and downstream processing techniques such as chromatography, filtration, and purification methods
• Conducting risk assessments and troubleshooting issues associated with technology transfer and manufacturing.
• Working closely with development teams to compile and document crucial process parameters and data essential for successful transfer.
• Partnering with Quality Assurance to ensure adherence to cGMP and other regulatory requirements.
• Participating in process validation endeavors and aiding in the resolution of deviations or discrepancies.
• Contributing to the ongoing enhancement of technology transfer processes and associated documentation.

Your Qualifications

• PhD or M.Sc. in biochemistry, protein chemistry, biotechnology, or a related field.
• Prior experience in process development and/or manufacturing within downstream processing.
• Proficiency in downstream processing techniques such as chromatography, filtration, and purification methods
• Familiarity with technology transfer processes, including documentation requirements, risk assessment, troubleshooting, and ensuring alignment with project timelines and quality standards.
• Demonstrated flexibility and eagerness to embrace and drive new tasks and challenges.
• Familiarity with regulatory requirements governing biopharmaceutical manufacturing (cGMP).
• Excellent English communication skills, both verbal and written.
• Ability to thrive in a collaborative, fast-paced, and dynamic work environment.

Application

• Please submit your CV and a short motivation letter. We encourage all qualified candidates to apply, even if you don’t meet every listed requirement.
• For questions related to the role, please reach out to the Senior Manager, Early Stage Process Transfer & Validation, Anita Ljubic on email aljubic@agcbio.com.
• Applications are only accepted through our recruitment system. We review CVs and conduct interviews on an ongoing basis, and the job posting will be closed once the position has been filled.

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
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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

• Collaborating with cross-functional teams to facilitate the smooth transfer of downstream processes from development to manufacturing.
• Leading and executing technology transfer tasks, ensuring alignment with project timelines and stringent quality standards.
• Offering technical proficiency in downstream bioprocessing, encompassing process scale-up and downstream processing techniques such as chromatography, filtration, and purification methods
• Conducting risk assessments and troubleshooting issues associated with technology transfer and manufacturing.
• Working closely with development teams to compile and document crucial process parameters and data essential for successful transfer.
• Partnering with Quality Assurance to ensure adherence to cGMP and other regulatory requirements.
• Participating in process validation endeavors and aiding in the resolution of deviations or discrepancies.
• Contributing to the ongoing enhancement of technology transfer processes and associated documentation