Scientist - Process Development, Drug Substance Lifecycle

**Scientist - Process Development, Drug Substance Lifecycle** **Position Summary:** + **Work Schedule:** M-F 8am-5pm + 100% on-site Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. **Catalent Pharma Solutions in Madison, WI is hiring a Scientist - Process Development, Drug Substance Lifecycle.** 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. **The Role:** + 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 **The Candidate:** + Ph.D. in STEM, or related field with at least 8 years of biopharmaceutical process development or manufacturing experience OR + MS in STEM, or related field with at least 12 years of biopharmaceutical process development or manufacturing experience OR + 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. + 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 **Why you should join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + Positive working environment focusing on continually improving processes to remain innovative + Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives + 152 hours of PTO + 8 paid holidays + Generous 401K match + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement - Let us help you finish your degree or start a new degree! **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. 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) .