USP Development Expert (f/m/d) (Duchnice)

Expert – Upstream Process Development (USP)

We are looking for an experienced Expert who will develop, optimize, and characterize upstream processes (USP) for biological products, working with cell cultures, bioreactors of various scales, and advanced data analytics. The role also includes regulatory support and technology transfer.

Key Responsibilities

• Leading USP projects from early development through technology transfer.
• Planning and supervising laboratory scale studies and operating bioreactors (15 ml–50 L).
• Designing experiments (DoE) and performing data analysis (JMP, process models).
• Supporting the preparation of CMC packages and regulatory documentation (e.g., BLA, MAA).
• Acting as a USP SME during regulatory interactions and due diligence activities.
• Cross functional collaboration with DSP, analytical, regulatory, and clinical teams.
• Mentoring junior staff and contributing to team capability development.
• Participating in technology transfer and supporting cGMP related activities.
• Presenting results and participating in project reviews.
   

Requirements

• Higher education in biotechnology, biology, biochemistry, pharmacy, chemistry, or related fields.
• Minimum 5 years of experience in the pharmaceutical/biotechnology industry.
• Expertise in USP process development and hands on work with bioreactors across scales.
• Experience in biosimilar development: CMC packages (BLA/MAA), interactions with EMA/FDA/MHRA, technology transfer, Consistency Runs/TPOS.
• Knowledge of regulatory, clinical, and IP requirements in biosimilar development.
• Advanced data analysis skills (JMP/DoE).
• Ability to prepare complex, “BLA ready” reports and documentation.
• Proactive approach to process improvement, QMS, and implementation of new technologies.
• Strong command of MS Office and MS Project.
• Very good English and strong communication skills.

What we offer

• Employment at a leading company in Poland’s biotechnology sector.
• Engaging and meaningful professional challenges.
• Competitive salary with annual and special occasion bonuses.
• Attractive benefits package, including:
  • Private medical care.
  • Life insurance.
  • Employee Pension Program (PPE) and Employee Retirement Support (PWE).
  • One additional paid day off per year.
  • Flex Benefits budget (choose from options like MultiSport or Pluxee lunch card).
  • Financial support for skill development.
  • Free transportation to the workplace (2 dedicated lines).
  • On-site cafeteria serving fresh breakfasts and lunches, with live cooking once a week.
  • Weekly fruit and vegetable days.
  • Access to psychological support.
     

At Rezon Bio, we believe in diversity and equality. Our recruitment process is conducted in a fully transparent manner and with respect for non-discrimination principles – regardless of gender, age, orientation, gender identity, or other individual characteristics. We encourage all individuals who meet the requirements to apply, including women, men, and non-binary persons. What matters most to us is your experience, skills, and passion for achieving goals together!