Principal Scientist, Biologics Formulation and Drug Product Development
Catalent
Anagni, Italy
6 gg fa

The Role

  • Provide scientific consultation and strategy across the European biologics network for formulation and drug product development.
  • Lead and partner with site Development and MS&T leads on biologics formulation development for client based project work and ongoing improvements.
  • Guide fill finish process development work including mixing studies, connectivity to fill finish equipment and single-use system compatibility.
  • Support choices in vial, syringe and other components based on impact to molecule and product.
  • Actively contribute to the strategic direction of the biologics network by recommending expansion or curtailment of investigations based on experimental results or scientific information.
  • Collaborate on technical transfer and scale-up support with MS&T and operations across as needed across the network.
  • Apply technical, functional, and industry knowledge to design formulation and scale-up experiments using DOE and QbD principles, review and analyze data, frame early and late phase project supporting work.
  • Review technical documents for accuracy, thoroughness and regulatory compliance
  • Train, coach, and mentor others in BIO development / MS&T and quality control on technical, personal development or business issues.
  • Participates in or leads client meetings offering technical support and leading the project.
  • Support development of business strategies and new technologies for multiple customers across multiple company sites
  • Develop and administer training webinars and courses for biologics formulation development including planning and leading workshops to help facilitate fundamental understanding of biologics degradation and formulation development strategy across the biologics network.
  • Routinely suggests new, innovative solutions to routine and complex problems.
  • The Candidate

  • PhD in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences and Chemical / Biological Engineering, or related scientific field with 8+ years of related industry experience or MSc in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences and Chemical / Biological Engineering, or related scientific field with 12+ years of related industry experience.
  • Experience in biologics formulation development and strategies and familiar with current industry best practice for sterile product development.
  • Experience in biochemical and biophysical methods for biologics molecular structure routine testing and deep characterization.
  • Familiar with the relationship of biologics molecular structure to stability.

  • Experience developing protein analytical methods including characterizing degradation of biologics molecule, familiar with biologics drug product degradation mechanism.
  • Experience in development of fill finish process of biologics including mixing studies, and single-use system.
  • Familiarity with the fill finish process impact to the biologics product quality is required.
  • Experience with lyophilization cycle development and optimization is preferred.
  • Experience with preparation of regulatory documents including FDA (BLAs, INDs, briefing documents) and EMA (CTD, MAA) and ICH Guidelines.
  • Demonstrated problem solving skills and written / verbal communication skills.
  • Ability to work independently within a team environment.
  • Demonstrated interpersonal skills to build relationships, act as change agent, and adapt to rapidly changing organizational and business needs.
  • Catalent’s standard leadership competencies that are used to interview and for Performance & Development :

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops
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