GMP Plasmids Senior Scientist

Andelyn Biosciences, Inc•Columbus, OH

1d•Onsite

About The Position

The GMP Plasmids Senior Scientist is responsible for guiding all aspects of Good Manufacturing Practices (GMP) and production in the Clinical Manufacturing Facility (CMF). Working in close collaboration with the GMP Plasmids Supervisor, the Senior Scientist will provide hands-on support and leadership for all day-to-day GMP production operations, including project timeline management and personnel. The Senior Scientist will aid in production efforts to deliver all products in a timely, compliant, and fiscally responsible fashion by providing leadership to staff working in the manufacturing facility as well as hands-on training to facilitate operations consistently following appropriate practices, batch records, and Standard Operating Procedures (SOPs) for manufacturing.

Requirements

Must possess relevant four-year degree OR relevant Masters OR relevant PhD, background in the life sciences, biotechnology or gene therapy industries preferred
Five years relevant (w/4 YR deg) OR two years (w/Masters)
Experience in biologics or gene therapy (plasmid manufacturing 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 highly 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
Attention to detail in all job functions
Infrequent travel required

Responsibilities

Provide leadership in daily operational activities related to the GMP manufacturing of biological products by leading and executing production processes, including assuring the availability of materials and the proper documentation surrounding GMP activities and product quality.
Work with GMP Management to enact the strategic direction of the GMP area.
Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
Set and maintain a professional standard within the GMP area.
Mentor, train, and supervise junior staff to assure the proper operation of facility equipment as well as the adherence to appropriate and accurate documentation surrounding activities and product quality.
Guide the Operations Staff in deviation investigations, OOS results, and process troubleshooting while working with GMP management and Quality Assurance.
Collaborate with GMP Management to ensure new projects and technologies are sought for incorporation into the GMP area.
Work with Management to ensure continuous improvement objectives are identified and met using metrics and other statistical means.
Support GMP resources and the supply chain, including maintaining materials inventory to meet production goals.
Write and review the creation and maintenance of Standard Operating Procedures that affect the conduct of operations within the Plasmid laboratory (equipment and process SOPs) and ensure they are written with proper scope, detail, and format to meet guidance.
Work to specific measurable objectives requiring operational planning skills with little direct supervision.
Solve, correct, and prevent problems, perform tasks as assigned by leadership, and delegate tasks to junior staff.
Work with management to answer client questions regarding their product.
Exercise discretion, judgment, and personal responsibility.
Operate within the management System applicable to the manufacture of phase appropriate material.
Demonstrate a high level of integrity.
Maintain a positive attitude.
Attention to detail in all job functions.
Make decisions based on established procedures.
Moderate involvement in customer relations.
Influences hiring, development and related personnel processes.
Other duties as assigned

Benefits

Eligible 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 Paid Holidays plus 2 floating holidays annually.
Company-paid 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)