Senior Associate 1, cGMP Biomanufacturing-Downstream (Sun-Wed, 2pm-12am) - SIGN ON BONUS OFFERED

Company: Catalent
Location: Madison
Posted on: June 25, 2022

Job Description:

Senior Associate 1, Biomanufacturing - Downstream (Wed-Sat 6am-4pm)Position Summary:The Manufacturing department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing production activities include solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production, and small-scale fill/finish. The Manufacturing team executes batch production records and SOPs in a cGMP environment, focusing on 'right first time' and on-time delivery.The Senior Associate 1 on the Downstream Manufacturing team is responsible for leading the manufacturing of biopharmaceutical products through the use of general analytical and liquid handling equipment. This role is also responsible for the use and maintenance of single and non single-use chromatography and filtration skids, as well as large scale chromatography column packing and qualification. The Senior Associate 1 serves as a project lead to ensure daily production activities are planned for and executed as required, communicating with other resource groups as required.This is a full-time, hourly position. Wednesday - Saturday 6:00am - 4:00pm.Our new, state of the art Madison, WI facility, with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing single-use systems, offers increased flexibility and manufacturing scale to support our customers' growth. We offer a broad range of integrated formulation and analytical services to solve your most difficult development challenges in Biologics.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.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 Role:Operates single-use biomanufacturing processing skids, including but not limited to, chromatography (single-use and non single-use), tangential flow filtration, and normal flow filtration.Performs packing, unpacking, and qualification of large-scale chromatography columns.Performs filling activities of final product within a Grade A (ISO5) environment.Serves as Room Lead for normal flow filtration, tangential flow filtration, and chromatography (single-use and non single-use) processes.Orchestrates execution of daily processing activities for the assigned roomPerforms verification of other team members' work.Communicates with floor support groups as required.Serves as Lot Lead and drives tactical preparations and batch closure tasksPerforms all pre-execution scheduling and planning for assigned production lot.Responsible for tactical execution of assigned production lot.Identifies and raises opportunities for procedural improvements. Drafts new SOPs and reviews/revises existing ones.Participates in and drives continuous improvement initiatives.Supports deviation investigations and change control/protocol execution in a time-sensitive fashion.Executes other duties as assigned.The Candidate:Bachelors or Associates Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 2 year of relevant experience, ORHigh School Diploma with a minimum of 5 years of relevant experienceClean room, aseptic technique, and/or general lab equipment experience.GMP experience preferred.Catalent Benefits:Defined career path and annual performance review and feedback processDiverse, inclusive culturePotential for career growth on an expanding team within an organization dedicated topreserving and bettering lives152 hours of paid time off annually + 8 paid holidaysCompetitive salary with yearly bonus potentialCommunity engagement and green initiativesGenerous 401K match and Paid Time Off accrualMedical, dental and vision benefits effective day one of employmentTuition reimbursementOn-site fitness center and wellness programsCatalent 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.

Keywords: Catalent, Madison , Senior Associate 1, cGMP Biomanufacturing-Downstream (Sun-Wed, 2pm-12am) - SIGN ON BONUS OFFERED, Other , Madison, Wisconsin