GMP Manufacturing Scientist I

Andelyn-Biosciences; Columbus (OH); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Paid Time Off

401(k) Match

Life Insurance

Tuition Reimbursement

Employee Assistance Programs

Flexible work options

LinkedIn Learning access

Job summary

Andelyn Biosciences in Columbus, Ohio is seeking a GMP Operations Scientist I to support all aspects of GMP production in the Clinical Manufacturing Facility. You will work with GMP management and staff to execute production processes, maintain documentation, and support facility and equipment maintenance with a focus on timely, compliant, and fiscally responsible manufacturing of biological products.

You will contribute to continuous improvement, ensure ALCOA documentation, and collaborate

Qualifications

• Must possess a relevant four-year degree and background in the life sciences, biotechnology, or gene therapy industries preferred.
• No minimum experience required but suspension experience is preferred.
• Experience in highly regulated fields preferred.
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
• Must be literate in Microsoft Office (PowerPoint, Excel, Word)
• Ability to work independently as well as collaboratively in a diverse and inclusive work environment.
• Must possess a client-focused mindset in daily tasks
• Must possess prior experience handling confidential information and the ability to maintain confidentiality

Responsibilities

• Supports GMP operations to execute production processes, documentation, and facility/equipment maintenance.
• Collaborate with GMP Management and staff to implement strategic direction and timelines.
• Maintain materials inventory control to meet production goals.
• Respond to alarm notifications from monitoring systems for storage units during the assigned period.
• Ensure proper documentation and adherence to SOPs for manufacturing biological products.
• Assist in process documentation reviews, revisions, remediation, and change controls.
• Adhere to ALCOA documentation principles in all production activities.
• Support deviation investigations, OOS results, and process troubleshooting.
• Work with GMP Management to identify and meet continuous improvement objectives using metrics.

Skills

Communication

Project management

Organization

Education

Four-year degree

Tools

PowerPoint

Excel

Word

Job description

Andelyn Biosciences in Columbus, Ohio is seeking a GMP Operations Scientist I to support all aspects of GMP production in the Clinical Manufacturing Facility. You will work with GMP management and staff to execute production processes, maintain documentation, and support facility and equipment maintenance with a focus on timely, compliant, and fiscally responsible manufacturing of biological products.

You will contribute to continuous improvement, ensure ALCOA documentation, and collaborate