GMP Scientist II - Solutions Prep

Andelyn Biosciences, Inc • Columbus, OH

3d • Onsite

About The Position

The Scientist II Production role will learn all aspects of the adeno associated viral (AAV) vector production. They will master procedures and be able to lead and coordinate their execution. The Scientist II will be responsible for adhering to cGMP principles while overseeing production teams in the production of AAV drug substances. They will work with Management and Senior Staff to plan and execute operations goals.

Requirements

• Must possess relevant four-year degree OR relevant master’s OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred
• Three years relevant (w/4 YR deg) OR no experience with (w/Masters)
• Experience in biologics or gene therapy preferred
• Experience in highly regulated field preferred
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
• Must be skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting
• 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

• Responsible for assisting and leading operations in the support of the production of viral vectors used in clinical trials
• Responsible for leading and performing daily operational activities related to the GMP manufacturing of biological products, by executing production processes including assuring the availability of materials and the proper documentation surrounding GMP activities and product quality.
• Contribute to material inventory tracking
• Learn all areas of operation involved in production activities
• Provide training to staff
• Anticipate, solve, correct, and prevent problems including error trending and CAPA implementation
• Solving, correcting, preventing problems, and performing tasks as assigned by leadership, as well as assigning tasks to junior staff
• Draft and revise SOPs and controlled documents
• Uphold a clean and safe work environment
• Understanding of Industry guidelines for drug product fill is required
• Working knowledge of various aseptic filling methods, including automatic and manual is essential
• Respond to, and take action from, alarm notifications from the applicable monitoring system(s) for laboratory temperature-controlled storage units that occur at any point during the assigned period of responsibility
• Oversee and train junior staff in GMP operations in a regulated work environment.
• Exercise discretion, judgment, and personal responsibility
• Demonstrate a high level of integrity
• Maintain a positive attitude
• Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
• Attention to detail in all job functions
• Operates in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved.
• Identifies problems and proposes solutions. Perform tasks as assigned by leadership
• Ability to work with some independence based on applicable experience
• Works in a diverse and collaborative team environment utilizing clear communication to deliver high productivity and contributes to the success of team and goals
• Documentation of all activities performed according to SOPs
• Adhere to good documentation principles and ALCOA in the support of all production activities
• Make decisions based on established procedures
• Nominal fiscal responsibility
• May require some travel
• Limited involvement in audits
• Limited involvement in customer relations
• Limited responsibility for inspection outcome

Benefits

• Competitive compensation
• Eligible on day one for medical, dental, and vision insurance plans with basic vision at 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.
• 4 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree