Principal Scientist, Drug Substance Process Lead

Job content

Job Description

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 Substance Process Lead, 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 leading Drug Substance process; providing process and scale-up expertise; supporting capability build out, due diligence, and readiness for tech transfer and cross functional efforts at EU Biologics site(s).

The Role

• In the first 1-2 years, the role will mainly support build out of Drug Substance Development and Manufacturing Capability at site. Overtime, the role evolves to:
• Lead and support biologics upstream 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.
• 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.
• 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 drug substance process development including planning and leading internal and external workshops.
  

The Candidate

• 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 in Biologics Drug Substance manufacturing capability and facility build out, DS facility design and cadence
• Experience in DS process development, deep knowledge of with biologics upstream process development strategies, and familiar with current industry best practices. Understanding of biologics downstream process is useful.
• Experience in Drug Substance process routine testing, process characterization and optimization.
• 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 Drug Substance process, material and environment impact to the biologics product quality.
  

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
  

Catalent offers rewarding opportunities to further your career!Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

Catalent. More products. Better treatments. Reliably supplied. ™

Visit www.catalent.com/careers to explore career opportunities.

C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.