Plasmid Development Senior Scientist

Overview of Andelyn Biosciences

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization.Located in Columbus, OH, the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non-cGMP activities.

Our Values are founded in our origin story.

The name “Andelyn” is a hybrid of two gene therapy patients who participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible.

Through this journey, we have been able to accelerate thedevelopment and manufacturing of innovative therapies to bring more treatments to more patients. We are Pioneering Solutions that Turn Hope into Reality™ through our ACCTSions.

ACCOUNTABLE in our actions.

CURIOUS to discover.

COMPASSIONATE in our thinking.

TRUSTWORTHY in our communications.

SUPPORTIVE of one another.

Employees are expected to perform the following essential functions under the framework of our ACCTSions.

What you will do.

The Plasmid Development Senior Scientist is responsible for aiding development activities within the Pre-clinical Plasmid team. The Senior Scientist has a working knowledge of microbial systems, bacterial metabolism, current bioprocessing technologies, and preferably has a track record of developing processes for the expression of plasmid DNA using microbial fermentation systems.

Working in close collaboration with leadership, the Senior Scientist Responsibilities include devising and executing various development projects for both upstream manufacturing and downstream purification of plasmid DNA. The Senior Scientist will also be expected to contribute to developing and reviewing procedures and Batch Record forms for fermentation processes as well as assist in the technical transfer of fermentation processes from process development to research-grade and GMP manufacturing.

Additionally, the Senior Scientist will troubleshoot issues as well as trend Critical Process Parameters and Critical Quality Attributes to aid in control of the process. Trend errors and work with management to implement the appropriate CAPAs to drive process improvement.

• Identify and coordinate development of experiments to fill knowledge gaps
• Responsible for providing technical guidance in daily operational activities related to the development of manufacturing processes.
• Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of the team and goals.
• Work with vendors to design and source new materials
• Anticipate and troubleshoot issues with operations to avoid interruptions in production
• Work with management to answer client questions regarding their product
• Solving, correcting, preventing problems, and performing tasks as assigned by leadership, as well as delegating tasks to junior staff
• Work to specific measurable objectives requiring operational planning skills with little direct supervision
• Responsible for the mentoring, training, and supervision of junior staff to ensure the proper operation of facility equipment as well as the adherence to appropriate and accurate documentation surrounding activities and product quality
• Works in close collaboration with Management to ensure continuous improvement objectives are identified and met using metrics and other statistical means
• Works in close collaboration with Management to ensure new projects and technologies are sought for incorporation into the Plasmid area
• Exercise discretion, judgment, and personal responsibility
• Demonstrate a high level of integrity
• Maintain a positive attitude
• Attention to detail in all job functions
• Performs in accordance with established policies, procedures, and techniques and requires training, common experience or working knowledge related to the tasks performed
• Documentation of all development activities performed according to SOPs
• Make decisions based on established procedures
• Has fiscal responsibility
• Infrequent travel required
• Moderate involvement in audits
• Moderate involvement in customer relations
• Moderate responsibility for inspection outcomes
• Influences hiring, development, and related personnel processes
• Mentoring and professional development of staff
• Other duties as assigned

What you bring to the team.

• Must possess a relevant four-year degree OR relevant master’s, OR a relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred
• Five years relevant (w/4 YR deg) OR two years (w/Masters)
• Ability to work with highly confidential materials and maintain confidentiality.
• Experience with prokaryotic cells is essential
• Knowledge and experience in aseptic technique, cell culture, liquid separation techniques, and/or fluid handling.
• Experience in plasmid production preferred
• Experience in fermentation 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

What you can expect when working at Andelyn.

• Pride in contributing to the development and manufacturing of lifesaving therapies.
• The invaluable experience of being a part of building the foundation of a new organization.
• The opportunity to collaborate with experts who have over 10 years in the gene therapy field.
• 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)

Andelyn Biosciences embraces diversity and is an equal opportunity employer and does not discriminate based on race, religion, national origin, gender, gender identity, genetic information, sexual orientation, protected veteran status, disability, age, or another legally protected status. As an organization, we are committed to creating an environment where everyone ACCTS.

Job Type: Full-time

Pay: $85,000.00 - $95,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid parental leave
• Paid time off
• Parental leave
• Referral program
• Relocation assistance
• Tuition reimbursement
• Vision insurance

Ability to Commute:

• Columbus, OH 43221 (Preferred)

Ability to Relocate:

• Columbus, OH 43221: Relocate with an employer provided relocation package (Preferred)

Work Location: In person