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Scientist I - GMP Operations Downstream Purification

Employer
Andelyn Biosciences
Location
Columbus, OH
Start date
Apr 17, 2024

Job Details

Overview of Andelyn Biosciences

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space.  The Andelyn Corporate Center (ACC) is dedicated to cGMP manufacturing, the Andelyn Development Center (ADC) for preclinical non-cGMP activities, and the Andelyn Plasmid Center (APC) for research and cGMP plasmid production.

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 the development 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 GMP Operations Scientist I is responsible for supporting all aspects of Good Manufacturing Practices (GMP) production in the Clinical Manufacturing Facility (CMF). Working in collaboration with the Manager of GMP Operations and staff. The Scientist I will provide hands-on assistance for all day-to-day GMP production operations, including execution of production processes, documentation, as well as facility and equipment maintenance. The Scientist I will support production efforts to deliver all products in a timely, compliant, and fiscally responsible fashion by following appropriate Standard Operating Procedures (SOPs) for manufacturing biological products.  This role will be focused on learning the aspects of downstream purification. Participate in the generation of reagents such as buffers and other critical raw materials used in the manufacture and purification of viral vectors.

 

  • Works in collaboration with GMP Management and Staff to cultivate and enact the strategic direction of the GMP area including the determination of schedule and project timelines/capabilities
  • Supports GMP resources and supply chain including maintaining materials inventory control to meet production goals
  • Performs daily operational activities related to the GMP purification of biological products, by executing production processes and assuring the proper documentation of GMP activities wearing cleanroom PPE.
  • Assists in process documentation review, revision, remediation, and process change controls
  • Learn the skills necessary for performing critical operations in the GMP manufacturing facility
  • Develop the ability to lead auxiliary operations
  • Adhere to good documentation principles and ALCOA in support of all production activities
  • Assists the GMP Management and staff with deviation investigations, OOS results, and process troubleshooting
  • Exercise discretion, judgment, and personal responsibility
  • Demonstrate a high level of integrity
  • Maintain a positive attitude
  • Learn procedures under the guidance of senior staff
  • 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
  • Display a high degree of attention to detail in all job functions
  • Identifies problems and performs tasks as assigned
  • Work under general supervision of senior staff and leadership
  • Works in a diverse and collaborative team environment utilizing clear communication to deliver high productivity and contribute to the success of the team and goals
  • Make decisions based on established procedures
  • Remain adaptive to changes in schedule
  • Other duties as assigned

 

What you bring to the team.

  • Must possess a relevant four-year degree, a background in the life sciences, biotechnology or gene therapy industries preferred
  • No minimum experience
  • Experience in highly regulated fields preferred
  • Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
  • Must be literate in Microsoft Office (PowerPoint, Excel, Word)
  • 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 be able to don PPE for extended periods of time (scrubs and full body cleanroom suit)
  • Must have experience and/ or understanding of biochemical purification techniques
  • Strong aseptic technique preferred
  • Ability to manipulate small objects  

 

What you can expect when working at Andelyn.

  • The pride of contributing to the development and manufacturing of life-saving therapies
  • The invaluable experience of being a part of building the foundation of a new organization.
  • The opportunity to work alongside 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.

 

Company

Andelyn Biosciences is a biopharmaceutical CDMO Pioneering Solutions That Turn Hope into Reality™. With 20+ years of experience manufacturing viral vectors, Andelyn's scientific expertise for development and characterization has led to GMP material being produced for over 75+ worldwide clinical trials and 400+ cGMP clinical batches. Advanced quality systems, full regulatory support, and supply chain vertical integration help accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. The name "Andelyn" is a hybrid of two gene therapy pioneers 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, representing all the families who have courageously participated in the research that make today's gene therapies possible. Continuing Andelyn's patient-based mission, the company is opening two state-of-the-art commercial manufacturing and development sites. The Dublin-based Andelyn Development Center is set to open in May 2022 and will house Andelyn's preclinical and development services. The 185,000 square foot Andelyn Corporate Center located on The Ohio State University's Innovation District will open for production in mid-2022.  

Company info
Website
Phone
614-580-8522
Location
1180 Arthur E. Adams Dr.
Columbus
OH
43221
US

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