Location: Harwell campus -OX11 0DF

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.

Overview

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. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.

The Manufacturing Process Execution team executes batch production records and SOPs in a cGMP environment, focusing on ‘right first time’ and on-time delivery.

The Role

Biomanufacturing – mRNA & Molecular Therapeutics

This position will oversee the development and execution of a multi-shift mRNA & Molecular Therapeutics Manufacturing team. The Manufacturing Manager will be responsible for the successful execution of non-platform projects in a clinical and commercial cGMP environment. They will ensure batch manufacturing readiness, meet production schedule deliverables, drive a continuous improvement culture, and continually optimize staff and operating model in support of client program requirements and site financial objectives.

Manages all assigned areas and directs activities so that approved products are manufactured on-schedule and within quality standards and cost objectives.
Hires, trains, motivates, leads, develops, and evaluates staff. Takes corrective action as necessary on a timely basis and in accordance with company policy. Ensures compliance with current federal, state, and local regulations. Consults with Human Resources Department as appropriate.
Informs personnel of communications, decisions, policies, and all matters that affect their performance, attitudes, and results.
Authors and revises Standard Operating Procedures (SOP), Batch Production Records (BPR) and Work Instructions (WI).
Leads technical calls, discussions, investigations, etc. for projects.
Maintains effectiveness of Quality system.
Ensures daily review and final sign-off of executed cGMP documentation (BPRs, forms) are completed.
Manages general cleanroom housekeeping, including room and equipment cleaning(s) and adherence to 5S standards.
Supports Technology Transfer into Biomanufacturing.
Identifies areas of efficiency gains across programs and implement within group. Manages and oversee continuous process improvement initiatives.
Coordinates with Director to prioritize and schedule activities to meet deadlines.
Manages completion of routine and preventive maintenance on Biomanufacturing equipment.
Manages/leads deviation investigations and change control/protocol execution in a time sensitive fashion.
Manages/executes equipment qualification/validation protocols, as required.
Executes other duties as assigned.
The Person

Bachelors or equivalent in a scientific, engineering or biomanufacturing discipline with relevant industry experience.
Demonstratable leadership experience.
Clean room, aseptic technique, and/or general lab equipment experience.
GMP experience preferred.
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.