Senior QC Scientist — Program Management Leader

Catalent; Harmans (MD); On-site; USD 110,000 - 120,000; Full time

Benefits offered by this job

Defined career path

Diverse, inclusive culture

Career growth opportunities

Job summary

Catalent's Harmans, MD facility seeks a Senior QC Scientist - Program Management to coordinate testing requirements between Quality Control and clients, ensuring timelines are met across internal and external labs.

The role collaborates with Project Management and other teams to establish testing processes, maintain schedules, and uphold quality standards in a GMP environment. Onsite work schedule is Monday–Friday, 8am–5pm.

Qualifications

• Bachelor's degree required with 4–8 years in a QC environment.
• Strong knowledge of GMP, ICH, FDA, USP/EP standards.
• Ability to manage multiple priorities in a fast-paced setting.
• Excellent written and verbal communication across cross-functional teams.
• Proficiency with MS Office, MS Project, and Smartsheet.
• Apply scientific, quality, and regulatory principles to support QC activities.

Responsibilities

• Serve as the primary QC liaison for clients, internal teams, and outsourced labs, aligning on requirements and timelines.
• Coordinate QC activities across PM, Process Development, Analytical Development, QC, and QA for GMP readiness.
• Manage internal and external testing execution, including method transfers and outsourced testing.
• Oversee sample management, reagents, and material inventories and logistics.
• Establish and coordinate stability programs with clients and internal teams.
• Create and maintain client sampling plans and testing schedules.
• Develop project trackers to monitor QC milestones and progress.
• Align manufacturing schedules with QC testing to ensure timely reporting.
• Communicate QC updates and project status to clients and stakeholders.

Skills

GMP & regulatory knowledge

Cross-functional collaboration

Analytical problem-solving

Project management

Communication skills

Education

Bachelor's degree in Biology, Chemistry, Engineering, Pharmacy, IT, or related discipline

Tools

Smartsheet

Microsoft Project

Excel

Job description

Catalent's Harmans, MD facility seeks a Senior QC Scientist - Program Management to coordinate testing requirements between Quality Control and clients, ensuring timelines are met across internal and external labs.

The role collaborates with Project Management and other teams to establish testing processes, maintain schedules, and uphold quality standards in a GMP environment. Onsite work schedule is Monday–Friday, 8am–5pm.