Andelyn Biosciences · 15 hours ago
Scientist II - Plasmid Production
Columbus, Ohio Metropolitan Area
Full-time
Onsite
Mid Level
3+ years expAndelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization. The Scientist II will be responsible for executing Good Manufacturing Practices (GMP) plasmid production and collaborating with management and senior staff to ensure efficient production operations and compliance with regulatory requirements.
BiopharmaBiotechnologyClinical TrialsManufacturingProduct Research
Responsibilities
Responsible for assisting and leading operations in the support of the production of plasmid product
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
Works in close collaboration with Management and Senior Staff to support the strategic direction of the GMP area including determination of schedule and project timelines/capabilities
Responsible for setting and maintaining a professional standard
Responsible for leading and performing daily operational activities related to the manufacturing of biological products, by executing production processes including assuring the availability of materials and the proper documentation surrounding activities and product quality
Exercise discretion, judgment, and personal responsibility
Anticipate, solve, correct and prevent problems including error trending and CAPA implementation
Draft and revise SOPs and controlled documents
Demonstrate a high level of integrity
Maintain a positive attitude
Operates within the Quality Management System applicable to the manufacture of phase appropriate material
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
Works in a diverse and collaborative team environment utilizing clear communication to deliver high productivity and contributes to the success of team and goals
Adhere to Good Documentation principles and ALCOA in the support of all production activities
Nominal fiscal responsibility
May require some travel
Limited involvement in audits
Limited involvement in customer relations
Limited responsibility for inspection outcomes
Other duties as assigned
Qualification
Required
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 2 years relevant experience with (w/Masters)
Knowledge and experience in aseptic technique, fermentation, cell culture, liquid separation techniques, and/or fluid handling
Experience in Biologics, Gene Therapy, or Plasmids required
Experience in highly regulated field
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
Benefits
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)
Company
Andelyn Biosciences
Andelyn Biosciences is a biopharmaceutical company that delivers treatments and therapies for patients.
201-500 employees
H1B Sponsorship
Andelyn Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (1)
Funding
Current Stage
Growth StageTotal Funding
$5MKey Investors
JobsOhio
2022-02-08Grant· $5M
Leadership Team
Wade Macedone
Chief Executive Officer
Adam Lauber
Chief Financial Officer
Recent News
Precedence Research
2025-11-27
Genetic Engineering News
2025-11-19
Company data provided by crunchbase