Senior Scientist for Late-Stage Downstream Process Development

Posted 2 Days Ago
Be an Early Applicant
Hiring Remotely in Copenhagen, Capital, DNK
Remote
Senior level
Biotech
The Role
Lead downstream development for late-stage biologics, design and execute experiments, analyze results statistically, author technical protocols and reports, contribute to FMECAs and regulatory control strategies, and provide cross-functional scientific support.
Summary Generated by Built In

Do you want to help customers bring life-saving biological products to market?

Do you thrive in a role where you can learn and grow? Do you value teamwork and love being part of a cross-functional team? If so, this position as a Senior Downstream Scientist in our Late-stage (Phase III) Process Development department is the perfect opportunity for you.
 

About the Department

The Late-Stage Process Development Department plays a key role in scaling processes from clinical to commercial manufacturing. We consist of three teams of technicians and scientists working across upstream, downstream and analysis.
 

We perform robustness studies, scale-down model qualification, process characterization (PC) studies, and resin lifetime studies. Our PC studies are conducted based on rigorous scientific and statistical principles, and their outcomes feed directly into risk assessments such as FMECAs (Failure Mode, Effects, and Criticality Analysis), which underpin regulatory submissions and control strategies.
 

We collaborate closely with departments such as Early-Stage Process Development, Analytical Method Development, MSAT and Manufacturing.
 

The Role

You will be responsible for the downstream aspects of development projects working with primarily mammalian, but also microbial, cell lines. Experience with either mammalian or microbial downstream process development is welcomed, provided you have a solid understanding of downstream processes.
 

You will bring scientific leadership through your technical depth, technical decision-making and scientific expertise to drive projects forward.
 

The job includes, among other topics, the following tasks:

  • Work with clients and internal project teams to successfully complete projects.

  • Coordinate development activities within your own area and participate in development activities across multiple disciplines if needed.

  • Design and execute, in collaboration with laboratory technicians, sophisticated, technically challenging experiments, and systematically evaluate results into clear presentations and reports.

  • Author technical documentation such as protocols and development reports.

  • Contribute to risk assessments, including FMECAs, to support control strategy definition and regulatory filings.

  • Provide scientific and technical support to the business.

Experience and Competencies

Required Qualifications

  • Master's or PhD in Biochemistry, (Bio)chemical Engineering, Process Technology, or similar, with 5+ years (Master's) or 2+ years (PhD) of relevant industrial experience.

  • Proven experience in downstream process development.

  • Ability to independently plan and report on complex development studies, including statistical analysis for multiple projects simultaneously.

  • Excellent communication and interpersonal skills.

  • Fluent in English, written and spoken.
     

Preferred Qualifications

  • Understanding of commercial manufacturing requirements and regulatory aspects (e.g., ICH guidelines and BLA submissions). This is considered an advantage but is

  • Experience with mechanistic modelling, scientific coding (e.g., Python, MATLAB) and/or liquid-handling robots (e.g., Tecan).
     

Application

Please submit your CV through our online recruitment system no later than 31 August 2026. Please note that we only accept applications submitted through our website. Applications sent by email cannot be considered.
 

To support an inclusive recruitment process and ensure an unbiased assessment of all candidates, please do not include a photo in your application.
 

For questions about the position, please contact Silvia Pirrung at [email protected] or +45 27 60 31 22

Who We Are 
AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in Denmark. From our Søborg site, we develop and manufacture life‑changing advanced biologics for some of the world’s most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.  

Skills Required

  • Master's degree with 5+ years or PhD with 2+ years in Biochemistry, (Bio)chemical Engineering, Process Technology, or similar
  • Proven experience in downstream process development (mammalian and/or microbial)
  • Ability to independently plan and report complex development studies, including statistical analysis across multiple projects
  • Excellent communication and interpersonal skills
  • Fluent English, written and spoken
  • Understanding of commercial manufacturing requirements and regulatory aspects (e.g., ICH guidelines, BLA submissions)
  • Experience with mechanistic modelling, scientific coding (e.g., Python, MATLAB) and/or liquid-handling robots (e.g., Tecan)
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The Company
HQ: Bothell, WA
2,241 Employees

What We Do

AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics (using mammalian and microbial systems), mRNA, pDNA, viral vector and cell therapy products, from pre-clinical to commercial production, including our proprietary CHEF1TM Expression System for efficient protein production with CHO cells. Our company DNA drives us to provide innovative solutions to partner with our customers in helping them reach their goals and accelerate their projects at our cGMP-compliant facilities in the US, Europe and Japan, as well as to facilitate approval and manage spending during the product lifecycle. We forge exceptionally strong partnerships with our customers and we never lose sight of our commitment to deliver reliable and compliant drug substance. Visit www.agcbio.com to learn more.

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