GMP Scientist - Plasmids

Andelyn Biosciences, Inc•Columbus, OH

About The Position

The Scientist I provides hands-on assistance with day-to-day plasmid production operations. The role executes production processes, documents work, and prepares and maintains inventory of in-house solutions used in plasmid production. It supports timely, compliant, and fiscally responsible delivery of products by following manufacturing practices, batch records, and SOPs for biological products. The Scientist I works with Plasmid Production staff to expand team knowledge and skills, learns to troubleshoot issues and trend errors, and works with management to identify process improvements. The position supports production of plasmids for basic research and toxicology studies, including coordinating and preparing critical solutions. The Scientist I operates within the applicable Quality Management System and regulatory requirements, documents activities according to SOPs, and works under the general supervision of senior staff and leadership. The role requires attention to detail, sound judgment, integrity, discretion, and effective collaboration and communication. Other duties may be assigned.

Requirements

Relevant four-year degree.
Excellent communication, organization, and project management skills, including the ability to manage multiple projects efficiently and adjust as priorities change.
Proficiency with 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.
No minimum experience required.

Nice To Haves

Background in the life sciences, biotechnology, or gene therapy industries.
Experience in a highly regulated field.

Responsibilities

Respond to and take action on alarm notifications from applicable monitoring systems for laboratory temperature-controlled storage units during assigned periods of responsibility.
Assist with production of plasmids used for basic research and toxicology studies.
Coordinate and prepare critical solutions used in plasmid production for research studies.
Follow applicable manufacturing practices, batch records, and Standard Operating Procedures (SOPs).
Operate within the Quality Management System applicable to manufacturing phase-appropriate material and maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
Document all activities according to SOPs.
Work with Plasmid Production staff to expand knowledge and skills, troubleshoot issues, trend errors, and identify process improvements with management.
Work under the general supervision of senior staff and leadership, making decisions based on established procedures.
Collaborate and communicate clearly with a diverse team to support productivity and team goals.
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, role specific.