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Lead - Process Development, Drug Substance Lifecycle
4 months ago
**Position Title**:Lead - Process Development, Drug Substance Lifecycle**
M-F 1st shift
**Summary**:
Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.
Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.
**The Role**:
- Knowledge of the principles of drug substance lifecycle management, particularly with respect to biologics process development and manufacturing is required.
- Successful experience interacting and liaising with internal and external clients, customers, and/or suppliers is required
- Experience working on late phase, process characterization, process performance qualification and commercial programs is preferred.
- Experience in product/process CMC life cycle management including pre-approval, launch and post-approval stages is preferred.
- Knowledge and experience working in biologics process development and supporting cGMP manufacturing is preferred
- Exceptional attention to detail and accuracy
- Experience in report and documentation skills
- Knowledge of statistical techniques for data analysis and reporting
- Skilled at risk mitigation for function.
- Direct personnel and / or organizational group management experience, including mentoring and training staff members cross-functionally
- Ph.D. in STEM, or related field with at 0 to 2 years of biopharmaceutical process development or manufacturing experience
- MS in STEM, or related field with 3 to 5 years of biopharmaceutical process development or manufacturing experience
- B.S/B.A. in STEM, or related field with at least 6 to 9 years of biopharmaceutical process development or manufacturing experience.
- Demonstrated excellence in prior roles can be a substitute for the minimum years of experience.
- Experience with statistical software (MiniTab, JMP, SAS, Tableau, Spotfire) and Microsoft Office, especially Excel and Word. Ability to learn and use software packages (e.g., TrackWise®, ComplianceWire®, Unicorn®).
- Lab and/or process scale chromatography and filtration (viral, chromatography, tangential flow) experience
- Strong technical knowledge and/or hands-on experience with biological manufacturing and validation concepts and procedures in a GMP environment.
- Capable of rapid learning of unfamiliar principles or techniques with minimum training.
- Ability to plan, schedule, and carry out work for successful project completion, while integrating timelines and meeting milestones.
- Strong interpersonal and presentation skills to discuss technical concepts internally and with clients.
- Demonstrated ability to understand and relay/incorporate expertise given from technical staff outside their area of expertise to their program.
- Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions.
- Ability to troubleshoot and collaborate on complex problems to identity solutions.
**P**osition Benefits**:
- 152 hours PTO & 8 Holidays
- Medical, Dental & Vision Benefits and 401k
- Tuition Reimbursement
**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 ser
