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Associate Lead II - Biomanufacturing, Compliance - Madison Wisconsin
Company: Disability Solutions Location: Madison, Wisconsin
Posted On: 05/03/2024
Associate Lead II - Biomanufacturing, ComplianceCatalent 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 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 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.The Manufacturing department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP 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. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.--The role will focus on investigating to determine root cause for deviations which occur during process execution. Additional responsibilities include creation and implementation of effective Corrective and/or Preventative Actions (CAPA) to prevent recurrence of deviations. GMP production activities include, but are not limited to, solution preparation, upstream cell culture, downstream protein purification, mRNA production and filling of Drug Substance.-- Candidates should possess strong technical writing skills and the ability collaborate with subject matter experts (SME's) from other departments.----This is a full-time on-site hourly position, Monday - Friday, 8:00am to 5:00pmCatalent 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: - Under minimal supervision, authors and revises complex deviation records, preventative actions and other related cGMP documents in a timely manner
- Familiar with upstream, downstream, materials management, production facility, systems, and technologies to facilitate the accurate completion of responsibilities
- Track/monitor and provide timely, accurate information regarding status of open investigations
- Participate in initiatives to improve process compliance culture, including on-going cGMP understanding and application
- Actively engage in Inspection Readiness activities and teams
- Write and revise SOPs (Standard Operating Procedures) when gaps are identified
- Provide support to internal and client audits as needed
- Responsible for exhibiting professional behavior with internal and external associates that reflects positively on the company and is consistent with the company's policies and practices
- All other duties as assignedThe Candidate: --
- Requires Bachelor's Degree in technical discipline (e.g., biology, biotechnology, engineering) or related life science field with minimum of 1 years' related experience, OR
- Associates Degree in technical discipline (e.g., biology, biotechnology, engineering) or related life science field with minimum of 4 years' related experience, OR
- High School Diploma with minimum of 6 years' related experience
- Must have fundamental understanding of pharmaceutical production operationsWhy you should join Catalent:
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