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Catalent Pharma Solutions Principal - Process Development, Drug Substance Lifecycle in Madison, Wisconsin

Position Title: Principal - 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.

Specific Duties, Activities, and Responsibilities:

This role will manage the lifecycle of drug substance programs as they progress though the development, validation, and manufacturing phases into late stage. This person will be the lead interdisciplinary Subject Matter Expert as a program moves to and through commercialization, including key technical support during regulatory agency inspections and queries, process characterization, process validation, and commercial program maintenance (e.g., Annual Product Reports [APRs], data trending/analysis). The candidate will provide general program oversight, coordinate the analysis and trending of analytical data, and provide technical input for protocols, reports, deviation investigations and / or process improvements. This position will be client-facing and require the ability to work collaboratively with clients and internal cross-functional stakeholders to move projects forward.

  • Work cross-functionally with Manufacturing Sciences and Technology, Manufacturing, Quality Assurance, Quality Control, Project Management, and other departments to ensure the success of a molecule’s lifecycle, including cross-site project management and coordination.

  • Author and review process characterization protocols and reports.

  • Own the process knowledge of the biologic product throughout the development and validation lifecycles; perform data analysis of historical batches to drive process characterization experimental design. Maintain oversight of the process capability through data trending and statistical analysis of critical variables; ensure processes are robust, in a continued state of validation, and continuously improving.

  • Prepare and review content for client meetings with a focus on data analysis and adherence to program timelines.

  • Provide technical leadership on strategic initiatives including tech transfers, process characterization, process validation, technical reports, data analysis, process monitoring, product comparability, and second line support of technical/scientific process and analytical issues.

  • Drive lifecycle improvements with consideration of their impact on filing, critical attributes, and specifications (comparability). Provide technical expertise while communicating decisions for process improvements, process understanding, and validation in collaboration with Catalent personnel and partners and justifying the strategies selected for client and regulatory agency review.

  • Act as the technical lead for validation process risk assessments. Support deviations, and CAPAs including root-cause analysis and corrective action identification.

  • Train, coach, and mentor others on early and late phase molecule lifecycle, personnel development, and business challenges (including integration of business and technical support).

  • Provide technical content for key documents (e.g., PPQ or comparability assessments, Control Strategies, Validation Plans, at-scale study protocols) and author content for regulatory submissions; present technical strategies during major health authority interactions and inspections.

  • Assure compliance with company directives including safety, staff training, and quality systems; mentor staff in lifecycle management

  • Support development of business strategies to expand molecule lifecycle and validation offerings

  • Review late-stage client statements of work (SOW) / requests for proposal (RFP) while advising the Business Development and Commercial Operations teams on appropriate scope

  • Demonstrate a thorough understanding of processes/systems related to the manufacture of drug substance.

  • Provide technical support during client visits and regulatory audits

  • Lead or support continuous improvement initiatives to increase revenue, throughput, or other key performance metrics for the site and network.

  • Perform other responsibilities to support group, site, and network-based initiatives, as required.

  • Other duties as assigned

Position Requirements:

Education:

  • Ph.D. in STEM, or related field with at least 8 years of biopharmaceutical process development or manufacturing experience

  • MS in STEM, or related field with at least 12 years of biopharmaceutical process development or manufacturing experience

  • B.S/B.A. in STEM, or related field with at least 15 years of biopharmaceutical process development or manufacturing experience.

  • Demonstrated excellence in prior roles can be a substitute for the minimum years of experience.

Experience:

• 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 required.

• 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 required

• 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 (matrix influence and management), including mentoring and training staff members cross-functionally

Technical Requirements:

  • 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.

  • Understanding and application of quality risk management and associated tools (Hazard Analysis, FMEA, etc.).

  • 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.

  • Ability to provide ideas, introduce new technology, and drive process improvements.

  • Ability to compose letters, outlines, memoranda, and basic reports and/or to orally communicate technical information.

  • Ability to make presentations, inside and/or outside the organization; comfortable speaking before groups.

  • Provide reliable and defendable interpretations of regulatory guidance for the customer and proven capability to defend said positions to regulatory agencies.

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.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .

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