GMP Scientist I

Andelyn Biosciences, Inc•Columbus, OH

About The Position

The GMP Operations Scientist I supports all aspects of Good Manufacturing Practices (GMP) production in the Clinical Manufacturing Facility (CMF). Working with GMP management and staff, this role provides hands-on assistance with day-to-day production operations, including executing manufacturing processes, maintaining documentation, and supporting facility and equipment maintenance. The scientist helps deliver products on time and in a compliant and fiscally responsible manner by following applicable practices, production documentation, and Standard Operating Procedures (SOPs) for biological products. The role contributes to GMP planning, scheduling, supply-chain and inventory support, production documentation, process changes, troubleshooting, deviation investigations, and continuous improvement. The scientist works under general supervision, follows the applicable Quality Management System and regulatory requirements, and collaborates with colleagues to support team and organizational goals.

Requirements

Relevant four-year degree.
No minimum experience required.
Excellent communication, organization, and project management skills, including the ability to manage multiple projects and adjust as priorities change.
Literacy in Microsoft Office, including PowerPoint, Excel, and Word.
Ability to work independently and collaboratively in a diverse and inclusive work environment.
Client-focused mindset in daily tasks.
Prior experience handling confidential information and ability to maintain confidentiality.

Nice To Haves

Background in life sciences, biotechnology, or gene therapy industries.
Suspension experience.
Experience in highly regulated fields.

Responsibilities

Work with GMP management and staff on the strategic direction of the GMP area, including schedules and project timelines and capabilities.
Support GMP resources and supply chain, including maintaining materials inventory to meet production goals.
Respond to alarm notifications from applicable monitoring systems for laboratory temperature-controlled storage units during assigned periods of responsibility.
Perform daily GMP manufacturing activities, including executing production processes and ensuring materials and documentation are available and appropriate for production and product quality.
Assist with process documentation review, revision, remediation, and change controls.
Learn skills required for critical operations in the GMP manufacturing facility and develop the ability to lead auxiliary operations.
Follow good documentation principles and ALCOA in production activities.
Assist GMP management and staff with deviation investigations, out-of-specification (OOS) results, and process troubleshooting.
Work with GMP management to identify and meet continuous improvement objectives using metrics and other statistical methods.
Operate within the Quality Management System applicable to manufacturing in the facility and maintain compliance with relevant regulatory requirements for cellular and gene therapy products.
Perform work in accordance with established policies, procedures, and techniques; identify problems and perform assigned tasks under general supervision.
Collaborate and communicate clearly in a diverse team environment to support productivity and team goals.
Document activities according to SOPs and make decisions based on established procedures.
Perform other duties as assigned.

Benefits

Competitive compensation.
Medical, dental, and vision insurance eligibility from day one; basic vision coverage is 100% company-paid.
160 hours of paid time off annually.
11 company-paid holidays plus 2 floating holidays annually.
Company-paid life insurance.
401(k) match.
Company-paid short- and long-term disability.
Four weeks of paid parental leave for birth and adoption.
Adoption assistance.
Tuition reimbursement and student loan repayment assistance.
Company-paid LinkedIn Learning access.
Employee Assistance Programs.
Flexible work options, depending on role.