GMP Senior Scientist - Operations

Andelyn Biosciences, Inc•Columbus, OH

About The Position

The GMP Operations Senior Scientist guides Good Manufacturing Practices (GMP) and production in the Clinical Manufacturing Facility (CMF). Working closely with the Manager and Supervisor of GMP Operations, this role provides hands-on support and leadership for day-to-day GMP production, project timelines, and personnel. The Senior Scientist helps deliver products on time, in compliance, and within fiscal responsibilities by leading staff and providing hands-on training to ensure manufacturing follows appropriate practices, batch records, and Standard Operating Procedures (SOPs). The position leads daily operational activities for GMP manufacturing of biological products, including production processes, material availability, documentation, and product quality. It supports GMP management’s strategic direction and continuous-improvement efforts, maintains inventory and supply-chain resources, trains and supervises junior staff, and guides staff in deviation investigations, out-of-specification results, and process troubleshooting in collaboration with GMP Management and Quality Assurance. The role also supports audits, customer relations, inspection outcomes, and personnel development. The Senior Scientist operates within the Quality Management System and applicable regulatory requirements for cellular and gene therapy products. The role requires accurate documentation, sound judgment, attention to detail, and the ability to work independently with little direct supervision while contributing to a diverse, collaborative team. Infrequent travel is required, and the employee must respond to applicable laboratory temperature-controlled storage-unit alarm notifications during their assigned period of responsibility.

Requirements

Relevant four-year degree, master’s degree, or Ph.D.
Five years of relevant experience with a four-year degree, or two years of relevant experience with a master’s degree.
Excellent communication, organization, and project-management skills, including the ability to manage multiple projects efficiently and adjust as priorities change.
High proficiency in Microsoft Office, including PowerPoint, Excel, and Word, with data interpretation and reporting skills.
Ability to work independently and collaboratively in a diverse and inclusive work environment.
Client-focused mindset in daily work.
Prior experience handling confidential information and ability to maintain confidentiality.
Attention to detail and ability to work to measurable objectives with little direct supervision.

Nice To Haves

Relevant background in life sciences, biotechnology, or gene therapy industries.
Experience in biologics or gene therapy.
Experience in a highly regulated field.

Responsibilities

Guide GMP activities and production in the Clinical Manufacturing Facility.
Provide hands-on support and leadership for day-to-day GMP production operations, including project timeline management and personnel.
Lead and execute GMP manufacturing processes for biological products, ensuring materials are available and GMP activities and product quality are properly documented.
Train and supervise junior staff in facility equipment operation, GMP practices, and accurate documentation.
Assign tasks to junior staff and solve, correct, and prevent operational problems.
Maintain a professional standard in the GMP area and work with GMP Management to enact the area’s strategic direction.
Support GMP resources and supply-chain activities, including ordering and maintaining inventory to meet production goals.
Maintain accurate documentation for GMP operations and document activities according to SOPs.
Work with GMP Management and Quality Assurance to guide staff in deviation investigations, out-of-specification results, and process troubleshooting.
Collaborate with GMP Management to identify and meet continuous-improvement objectives using metrics and statistical methods.
Collaborate with GMP Management to seek new projects and technologies for incorporation into the GMP area.
Respond to and take action on applicable laboratory temperature-controlled storage-unit monitoring alarms during assigned periods of responsibility.
Operate within the applicable Quality Management System and comply with regulatory requirements for cellular and gene therapy products.
Exercise discretion, judgment, and personal responsibility; make decisions based on established procedures.
Support a diverse and collaborative team through clear communication, leadership, and high productivity.
Participate in audits, customer relations, and activities affecting inspection outcomes.
Influence hiring and related personnel processes; mentor staff and support their professional development.
Manage multiple projects and adjust as priorities change.
Perform other duties as assigned.
Travel infrequently as required.

Benefits

Competitive compensation.
Medical, dental, and vision insurance eligibility on day one; basic vision coverage is 100% company-paid.
160 hours of paid time off annually.
11 company-paid holidays and 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.