Jobs at Catalent, Inc.

Leads a biologics analytical characterization team, planning and executing laboratory work under cGMP requirements. Manages junior scientists, oversees technical communications with clients and internal teams, supports audits and client visits, conducts performance and HR activities, and fosters team development, quality, safety, and compliance. The role requires expertise in biology, chemistry, biochemistry, analytical techniques, coaching, customer resolution, and managing multiple complex projects.

Optimize biologics manufacturing processes, lead technical support for risk assessments, deviations, change controls, CAPA, and root-cause investigations. Support equipment specifications, FAT, SAT, qualification, and validation activities. Lead cross-functional site strategy and improvement projects, troubleshoot manufacturing issues, manage single-use consumables and raw materials, analyze process data, and support compliance, SOP development, and continuous improvement in a cGMP environment.

Performs equipment lifecycle activities, including installation, onboarding, calibration, maintenance, troubleshooting, and retirement. Prepares SOPs, validation documents, design files, and change controls; manages asset requests and coordinates activities with internal and external stakeholders. Supports training, preventative maintenance, new technology introduction, and process improvements in a GMP biologics manufacturing environment.

Coordinates site-wide training programs covering onboarding, GMP, safety, quality, compliance, and workforce development. Facilitates orientation and group learning, develops instructional materials with subject matter experts, administers ComplianceWire and training records, monitors completion, produces compliance metrics, and evaluates training effectiveness. Partners with Production, Quality, Engineering, Safety, and HR to address training needs and improve employee capability, quality performance, and operational efficiency in a regulated manufacturing environment.

Manage multiple engineering and capital projects in an FDA-regulated gene therapy manufacturing environment. Responsibilities include project scheduling, milestone tracking, budgets, invoices, purchase orders, documentation, vendor coordination, change controls, deviations, SOP follow-up, project governance, and cross-functional communication. The role supports engineering subject matter experts, maintains compliance with pharmaceutical standards, coordinates onsite vendors, and helps minimize manufacturing downtime across Catalent’s Maryland sites.

Monitors pharmaceutical regulations, pharmacopoeias, GMP guidance, and corporate standards; coordinates compliance plans and regulatory updates. Supports quality risk management, CAPA and continuous improvement actions, supplier and manufacturer qualification, and quality monitoring. Coordinates GMP onboarding, annual requalification, and periodic training programs. The role requires pharmaceutical quality systems knowledge, regulatory expertise, risk management understanding, strong computer skills, and intermediate English.

Manage incoming and outgoing API materials and supplies while following cGMP, quality, safety, and client-specific procedures. Record receipt, sampling, transfer, and shipment information; coordinate priorities with Technical Services and Quality Assurance; handle temperature-monitoring supplies; safely load and unload couriers; move warehouse materials; and assist with cycle counts. The role requires completing IATA and DOT hazardous-material shipping certifications.

Supervise regional operations across pre-production, pre-distribution, and master data departments. Lead daily priority discussions, coordinate teams and sites across functions and time zones, manage regional deliverables, and support continuous improvement initiatives. The role requires operational leadership, compliance focus, strong organization, and prior supervisory or team leadership experience in clinical trial materials, supply chain, master data, or related operations.

The Associate Director of Quality Assurance leads QA support for clinical and commercial manufacturing, ensuring compliance with cGMP regulations and managing QA teams and processes.

Supervise daily QA activities on the packaging and distribution floor, ensuring cGMP and SOP compliance. Lead audits, line clearance, cleaning verification, investigations, and root-cause analysis. Train and mentor associates, author SOPs, identify continuous improvement opportunities, and communicate with internal/external stakeholders to resolve issues and complete projects on schedule.

The Sr. Manager oversees plasmid DNA manufacturing operations, ensuring compliance with GMP standards, leading a manufacturing team, and improving production performance.

The Senior Accountant will manage financial processes, including transaction analysis, balance sheet reconciliations, reporting, and compliance with US accounting standards.

Support development and optimization of biologic manufacturing processes. Execute upstream cell culture and downstream purification experiments (AKTA, TFF), analyze data using DoE, maintain GMP-compliant documentation, support tech transfer, troubleshoot, and contribute to continuous improvement and lab operations.

Act as primary site contact for assigned commercial accounts, ensuring customer satisfaction and successful execution of commercial manufacturing programs. Align forecasts and demand plans with operations, lead onboarding of new commercial clients, develop scalable account management and planning processes, and drive cross-functional communication and issue resolution.

Lead packaging and labeling operations for clinical and small-scale commercial production, driving cGMP compliance, manufacturing schedule adherence, budgets, continuous improvement, capital project readiness, client and regulator engagement, and staff development.

The Senior Associate Scientist conducts analytical evaluations of macromolecules, develops and optimizes methods, and supports quality control validation while adhering to regulatory standards.

Support and administer computerized laboratory, manufacturing, and enterprise systems onsite. Perform system administration, troubleshooting, CSV/GxP compliance tasks, assist technology implementations and validation, respond to audit observations, and collaborate with vendors and cross-functional teams to maintain data integrity and improve lab/production computer systems.

Lead and manage the proposal and quotation process, coordinating cross-functional teams (BD, Operations, Finance, Quality) to produce accurate, cost-effective, and timely proposals. Perform pricing and margin analysis, maintain client-specific pricing templates, engage directly with clients, and support continuous improvement of quote-to-actual cost performance.

Oversees quality assurance functions, ensuring compliance with regulatory requirements, managing teams for audits and inspections, and developing strategies to improve processes.

Lead and grow Process Development teams to deliver scalable upstream and downstream biologics processes from early-phase through commercial readiness. Oversee expression, purification, process characterization, technology transfers, and manufacturing support while aligning cross-functional and client stakeholders and driving multi-site strategic initiatives and continuous improvement.