Downstream workstream lead

FUJIFILM Biotechnologies

As the Downstream Workstream Lead, you will lead the end-to-end transfer, optimization, and implementation of downstream processes into our state-of-the-art manufacturing facility—transforming development strategies into robust, right-first-time GMP operations. You’ll lead a cross-functional team of SMEs across Process Science, MSAT, Manufacturing, QA, QC, Supply Chain, and Automation—forming the backbone of our Tech Transfer core teams.

With a sharp focus on process development, you will translate process knowledge into scalable, compliant, and efficient operations—steering activities from new product introduction to validation and continuous improvement, accelerating speed-to-plant while safeguarding quality and patient impact.

What You’ll Do

Lead the downstream workstream from late-stage development through facility fit, scale-up, validation, and PPQ; represent the workstream at core team level.
Plan and execute tech transfer strategies, including process mapping, FMEA-driven risk management, and change control aligned with site and client requirements.
Guide key development activities and documentation (TT packages, protocols/reports, BRs, URSs, validation plans, PPQ/CPV) to ensure technical integrity and compliance.
Own timelines and critical path; ensure readiness across documentation, materials, equipment, and training while facilitating effective internal and customer meetings.
Champion digital, data-driven execution and continuous improvement to enhance process robustness, throughput, and right-first-time performance.

Qualifications

Required

Strong customer acumen and relationship-building skills with a solutions mindset.
Excellent communication and cross-functional leadership to align teams and drive outcomes.
Background in protein purification with proven experience transferring large-scale downstream processes.
Independent working style with demonstrated ability to lead diverse technical groups.
Blend of technical depth and project management capability; adept at risk management and decision-making.
Proficiency with project planning software and digital collaboration tools.

Preferred

MS with 7+ years, or BA/BS with 9+ years of relevant experience in Biotech/Biopharma.
Experience in CDMO or biopharmaceutical manufacturing environments.
Track record navigating complex, fast-paced programs from development through validation.
Familiarity with QbD, DoE, PAT, data visualization/analytics, and digital tools that enhance process efficiency.

The Team and Our Culture

At FUJIFILM Biotechnologys Denmark, innovation and execution go hand in hand. You’ll join a highly skilled, collaborative downstream technical team that values scientific rigor, continuous learning, and shared success. We support your growth with meaningful challenges, exceptional teammates, and opportunities to shape how lifesaving therapies reach patients.

How To Apply

Submit your CV highlighting your downstream/process development experience and leadership across tech transfer and manufacturing. We look forward to seeing how you’ll elevate our capabilities and impact.

Deadline is the 17th of June

FUJIFILM Biotechnologys is a global leader in biologics contract development and manufacturing (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle—from breakthrough cures to life-saving vaccines.

Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.

Shape the future with us—your drive meets boundless opportunity here: https://fujifilmdiosynth.com/

FUJIFILM Biotechnologys Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identity, or any other protected class.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via email, the internet, or any form/method will be deemed the sole property of FUJIFILM, unless such firms were engaged by FUJIFILM for this requisition and a valid agreement is in place. In the event a candidate submitted outside of the FUJIFILM agency engagement process is hired, no fee will be paid.