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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 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 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 dont meet every listed requirement.
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 2500 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.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.
Required Experience:
Senior IC
Full-Time