Catalent Pharma Solutions is the leading Contract Development and Manufacturing Organization (CDMO). Within Catalent, Biologics is a fast-growing business unit focused on providing innovative technologies and product solutions our clients and patients.
Process, analytical and formulation development laboratories in Madison, WI and Bloomington, IN support clinical and late phase programs.
Drug Substance (DS) manufacturing is accomplished in Madison; DS and Drug Product (DP fill and packaging) manufacturing for clinical and commercial products is done at Bloomington.
In addition, pre-filled syringe (PFS), vial fill and packaging sites provide solutions in Brussels, Belgium, Anagni, Italy and eventually in Limoges, France.
All Catalent Biologics sites are expanding significantly. We are leveraging our differentiated technology, world class manufacturing capability, and integrated services across the Catalent network to drive significant growth and deliver solutions for clients and patients.
The Principal Scientist, Drug Product Manufacturing Science & Technology , will support Catalent Biologics for the development and manufacturing of client products and processes.
The network role is a new one and will be an exciting opportunity to align best practices and build capability. Responsibilities include supporting cross functional efforts at 3 of the EU Biologics sites and ad-hoc support to Bloomington DP site in the US.
Lead and support formulation and fill-finish process-fit-to-plant, Tech Transfer and associated analytical procedures for client programs including process gap assessments, facility fit and recommendation of equipment / process improvements, strategic studies for mitigation and developing process control strategies.
Support risk analysis / FMEA based on (p)CQAs / CPPs.
Apply technical, functional, business and / or industry knowledge to design experiments / projects; provide scientific consultation to the department / discipline / group.
Support sites in the translation of new Regulations (e.g. Annex 1) into effective solutions to be implemented at site(s).
Assess transferred formulation and fill-finish process and process analytical procedures.
Assure work to be developed, executed and transferred is informed by knowledge of the unit operations, process parameters, and process information.
Collaborate with Drug Product Development team (including Formulation and Bioanalytical) to assure that process work is effectively planned and informed by biologics molecular structure.
Use DoE and QbD approach to gain statistical knowledge and understanding of phase appropriate process design space to guide decisions and / or assess impact to product or process.
Actively contribute to the strategic direction of the biologics network by recommending expansion or curtailment of investigations based on experimental results or scientific information.
Participate in or lead client meetings offering technical support and leading the project; collaborate with other Catalent team members.
Develop and administer training webinars and courses for formulation / fill-finish / visual inspection / packaging and Auto-injectors / New devices process development including planning and leading internal and external workshops.
PhD in Chemistry, Biochemistry, or related scientific field with 8+ years of related industry experience.
MSc in Chemistry, Biochemistry, or related scientific field with 12+ years of related industry experience
familiar with current industry best practices.
Experience in facility fit, technical transfer of drug product formulation, fill-finish processes, process routine testing, process characterization, improvements.
Familiar with all aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones.
Familiar with the formulation and aseptic fill-finish processes, material and environment impact to the biologics and mRNA / LNP product quality.
Experience with preparation of regulatory documents including FDA (BLAs, INDs, briefing documents) and EMA (CTD, MAA) and ICH Guidelines
8-12+ years of experience related experience required and GMP experience preferred
Catalent’s standard leadership competencies that are used to interview and for Performance & Development :
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Coaches and Develops