Scientist II – Analytical Development – Method Qualification and Validation

It’s an exciting time to join us!

The Andelyn Biosciences’ Manufacturing group is seeking a motivated individual to join our growing team as a Scientist II – Analytical Development.

The Scientist II – Analytical Development (Method Qualification and Validation team) will be responsible for execution of various molecular biology, chemistry, microbiology, and protein chemistry assays to support analytical development of manufactured products. This position will support method qualifications, validations, and technology transfers and will work closely with the Quality Control and Quality Assurance departments. Work is conducted under strict adherence to standard operating procedures and following Good Manufacturing Practice (GMP) guidelines. Secondary responsibilities include peer review of analytical development testing documentation, deviation documentation, assist with laboratory investigations, SOP generation or revision, training of junior staff, and other tasks needed to support the primary responsibilities.

Schedule: Full-time (Benefits Eligible)

Location: Central Campus

575 Children's Crossroads

Columbus, OH 43205

Under the guidance and direction of the Supervisor – Analytical Development essential functions of the Scientist II – Analytical Development include at a minimum:

Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the Clinical Manufacturing Facility (CMF).
Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
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.
Identifies problems and proposes solutions. Performs tasks as assigned by leadership.
Ability to work with some independence based on applicable experience.
Works in 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.
Make decisions based on established procedures.
Nominal fiscal responsibility.
May require some travel
Limited involvement in regulatory and client audits
Limited involvement in customer relations
Limited responsibility for inspection outcomes
Exercise discretion, judgment and personal responsibility.
Demonstrate high level of integrity in all aspects of the position.
Maintain positive attitude.
Other duties as assigned.

Knowledge, Skills and Abilities required:

Relevant four-year degree OR relevant master’s OR relevant PhD
Four years relevant experience with 4-year degree OR no minimum experience with master’s degree or PhD.
Experience in a highly regulated field required; GMP experience preferred
Experience with method qualification, validation, and/or tech transfers required
Effective communication and interpersonal skills required.
Skills in operating a personal computer, and word processor. Must be familiar with various software packages (e.g., Word, Excel, PowerPoint).
Ability to work with highly confidential materials.

Minimum Physical Requirements

Sitting for extended periods Constantly (67-100%)

Talking on the phone/in person Constantly (67-100%)

Typing on a computer keyboard Constantly (67-100%)

Standing/walking Occasionally (0-33%)

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.

EOE M/F/Disability/Vet

Andelyn Biosciences is currently operating under Executive Order 14042 that requires that employees of federal contractors and its affiliates be vaccinated against COVID-19, with some limited exemptions under the law. As Andelyn is both an affiliate and will be a federal contractor, proof of vaccination status will be required prior to first date of employment. Religious and medical exemptions may be considered depending upon the specific job duties and in accordance with applicable federal guidelines.