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Manager - Manufacturing Sciences & Technology, Operational Engineering

1 month ago

Madison, United States Catalent Inc Full time

Manager - Manufacturing Sciences & Technology Operational EngineeringSummaryCatalent 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 Manufacturing Sciences and Technology (MS&T) department's primary function is to serve as an agile technical services team to support process & technology transfer (e.g., mAbs, fusion proteins, mRNA, new modalities, etc.), equipment, consumables, technical writing, and drug substance lifecycle management. The MS&T organization supports the Madison facility as well as the Catalent Biologic's network through client-facing support, on-the-floor or on-call technical coverage, and continuous improvement. The team is broken down into three key subgroups:MS&T, Upstream Technology TransferMS&T, Downstream Technology TransferMS&T, Operational EngineeringMS&T, Technical WritingThe Operational Engineering group primary function is to provide technical support for the manufacturing execution team. This includes on the floor or on-call support during execution. The team will be the subject matter experts on the manufacturing process and equipment and provide input in the design of consumables and batch records/SOPs to support operational success. This is a full-time on-site position, Monday - Friday 8:00am-5:00pm.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. The RoleLead a team in technical support of Manufacturing, including on the floor support and technical improvements for equipment and processes.Lead a group of engineers, scientists, and other colleagues to provide technical support of Manufacturing, including the technology transfer between external clients or Process Development and Manufacturing.Perform responsibilities associated with the evaluation, alignment, and recommendation of equipment and process improvements.Support technology transfer of processes into manufacturing for both internally and externally developed processes.Use comprehensive knowledge of applicable principles, concepts, and practices and/or techniques to lead complex projects within a department, group, or team in a single function or focus.Apply technical and functional knowledge to design experiments/projects that contribute to overall direction of department/discipline.Participate in and support strategic alignment across Catalent Biologics sites and the Madison site.Work closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing.Lead and/or support the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations.Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.Responsible for maintaining a high-performing team by hiring, training, motivating, evaluating, and developing staff (direct reports and others).Other duties as assigned.The Candidate Bachelor's degree in a STEM discipline and 9+ years related experience, ORMaster's degree in a STEM discipline and 7+ years related experience, ORDoctorate Degree in a STEM discipline and 4+ years related experienceDirect personnel and organizational group management experience, including mentoring and training staff members cross-functionally required.Minimum of 3 years' experience in a people leadership role preferred. Ability to work with and lead other groups to develop, qualify, and transfer methods and drive complete investigation, deviation, and change control practices.Strong technical knowledge and hands-on experience with biological manufacturing and validation concepts and procedures in a GMP environment.Influential leader/SME of Upstream (mammalian cell culture) or Downstream (e.g., depth filtration/clarification, chromatography, tangential flow filtration, viral filtration, BDS fill, etc.) manufacturing processes across cGMP biologics production scalesExperience in facility fit, process scaling, and technology transfer required.Experience in equipment engineering and process improvementsExcellent written and verbal communication skills with internal and external customers.Experience with operating and troubleshooting process equipment, including single-use systems and consumablesExperience working on late phase, process performance qualification, and commercial programs is a plusDemonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.Safety and Environmental Requirements:May be exposed to inclement weather or be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety of others.Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.Occasional stooping, kneeling, crouching, bending, carrying, grasping.Frequent lifting and/or moving up to 20 pounds and occasional lifting and/or moving up to 50 pounds.Must comply with EHS responsibilities for the position.Working conditions will be heating ventilation and air condition controlled.Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning.Why you should join Catalent:Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives152 hours of paid time off annually + 8 paid holidays Competitive salary with yearly bonus potential Community engagement and green initiatives Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employmentTuition 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 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 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.