Principal Scientist, Downstream Process Development

Position Title: Principal Scientist, Downstream Process Development

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.

Catalent Biologics is also making significant investments in people and processes to match the investment in capital. The Product Development (PD) network supports development of biologic modalities including monoclonal antibodies (mAbs), novel protein modalities, mRNA, exosomes, enzymes, and viral proteins from initial early phase through late stage projects to PPQ and launch. We are building and leveraging best-in-class project management, process, formulation and bioanalytical platforms to drive solutions.  A growing portfolio of programs drives the need to identify strategic initiatives to evolve and grow the Biologics business in alignment with Catalent’s company strategy. The project and portfolio management program covers client work at 5 Biologics sites in the US and Europe. We are building and expanding our teams at each site. People joining our team will have the opportunity for career development as our business continues to grow and expand. 

The Principal Scientist, Downstream Process Development, will support Catalent Biologics for the development and manufacturing of client products and processes. This role supports Madison site needs in Automation for downstream process (DSP), process technology, scale-up, real time monitor and control for DSP and supports Bloomington site working on difficult molecules.  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 2 of the US Biologics sites. Process and analytical development is critical to successful drug substance scale-up for clinical and late stage biologics manufacturing. Collaboration with the US biologics and eventually broader EU leads will be a key responsibility for this role. Specific areas of involvement include downstream processing methodologies and analytical procedures assessment/development and deeper studies for linkage to unit processing specifications, set points, downstream strategy; process control strategy including data collection requirements, monitoring and collecting criteria; We are also advancing our innovation program and downstream processing/analytical strategic assessments will be a key feature. A strong collaborator is needed who will work effectively across functions and sites.

The Principal Scientist will be based in the US and report to the Director, Integrated Network while also working with the site PD and MS&T Directors. Some travel to relevant sites will eventually be needed to evaluate capabilities and implement projects. The Scientist can work remotely if desired and may not need to relocate.

Specific Duties, Activities, and Responsibilities:

• Lead and support Madison Automation for downstream process (DSP), process technology, scale-up, real time monitor and control for DSP and support Bloomington sites working on difficult molecules.
• Lead and support biologics downstream processing development and associated analytical procedures for client programs including process gap assessments and developing process control strategies.
• Apply technical, functional, business and/or industry knowledge to design experiments/projects; provide scientific consultation to the department/ discipline/group.
• Assess transferred downstream 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 Bioanalytical team 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.          

• Collaborate on technical transfer and scale-up support with MS&T and operations as needed across the network.
• Support client visits and working teams.
• Apply technical, functional, and industry knowledge to design and evaluate upstream process, review and analyze data, frame early and late phase needs.
• Review technical documents for accuracy, thoroughness and regulatory compliance
• Train, coach, and mentor others in BIO network.
• 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 downstream process development including planning and leading internal and external workshops.
• Routinely suggest new, innovative solutions to routine and complex problems.
• Support strategic efforts for new and evolving downstream process.

Typical Position Requirements:

Education:

• 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

Experience:

• Experience in downstream process development, deep knowledge of with biologics downstream process development strategies and familiar with current industry best practices.
• Experience in downstream process routine testing, process characterization and optimization. Knowledgeable in automation, real time monitor and control of DSP.
• 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 downstream process, material and environment impact to the biologics product quality.
• 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.
• 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
• Delivers Results
• Demonstrates Business Acumen
• Fosters Collaboration and Teamwork
• Champions Change
• Engages and Inspires
• Coaches and Develops