General Description

Andelyn Biosciences is an industry-leading cGMP production facility dedicated to advancing the field of gene therapy. Our mission is to use our knowledge, resources, technology, and experience in translational and regulatory science, to develop new, safe, and effective long-term treatments for diseases. There is no disease too rare and no challenge too difficult, as we strive to make a difference with every product and to leave hope in the minds of every patient and family. Andelyn is primarily a full-service manufacturer of Adeno Associated Virus (AAV). We work with over 100 clients each year to manufacture AAV at development, toxicology, clinical and commercial quality.

The primary responsibility of the Metrology Specialist II is the application of measurement science, mathematics, and electronics for calibration inspection, measurement, and test equipment of various cGMP/non-GMP disciplines ensuring measurement functional accuracy. Identify and utilize appropriate measurement, and preventative maintenance activities for critical manufacturing processes. Adapt equipment, standards/procedures to accomplish critical measurements and preventative maintenance deliverables. Performing corrective actions to address identified measurement and reliability problems, including activities developing writing/reviewing documents in support of the change control process. Additional responsibilities include managing the receipt/shipment of equipment, managing outsource calibration by vendors, preparing/reviewing deviation documentation, providing support during audits, and other tasks as needed to support department and business functions.

Location: Andelyn Corporate Center

1180 Arthur E. Adams Dr.

Columbus, OH 4322

Principal Duties and Responsibilities

• Preserve equipment readiness so that customer needs relating to the conduct of testing are met in a suitable manner.
• Maintain equipment within established parameters governing regulatory compliance expectations.
• Make certain all equipment is entered, scheduled, and maintained in the appropriate CMMS system.
• Ensure all equipment documentation is complete, up-to-date, and stored properly.
• Maintain and update calibration data as required.
• Evaluate calibration/qualification records supplied by third-party vendors.
• Document all findings in compliance with cGMP standards.
• Coordinate outside calibration testing for equipment as needed.
• Assume a lead role in Out of Tolerance Investigations when necessary.
• Participate in department and/or company-wide medium projects designed to improve the nature of customer service.
• Participate in customer audits as directed by Quality Management.
• Authors and reviews department SOP’s, risk assessments, and equipment calibration protocols.
• Communicates with equipment users for procedure updates.
• Cultivates a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals.
• Mentors' equipment users on new equipment.
• Ability to work through GMP processes for equipment failures.
• Exercises crucial people skills.
• Exercise discretion, judgment, and personal responsibility.
• Demonstrate a high level of integrity.
• Maintain a positive attitude.
• 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.
• 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 performs tasks as assigned.
• Work under the general supervision of senior staff and leadership
• Works in a diverse and collaborative team environment utilizing clear communication to deliver high productivity and contributes to the success of the team and goals.
• Documentation of all activities performed according to SOPs.
• Make decisions based on established procedures.
• Nominal fiscal responsibility.
• Other duties as assigned.

Knowledge, Skills, and Abilities, Required

• BA/BS in a scientific field plus 3 years of job experience. In lieu of a degree, four years of relevant laboratory, cleanroom, and or manufacturing experience in a regulated environment and dealing with general and biological process equipment are required.

• Thorough knowledge of scientific principles required (general SOPs, GMP/GLP, and ISO regulations).

• 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 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 possess prior experience handling confidential information and the ability to maintain confidentiality.

Minimum Physical Requirements

• Occasionally Sitting
• Frequently Walking/Standing/Stooping
• Independently lifting up to 50 pounds
• Occasionally talking on the phone or in person
• Frequently typing on a computer keyboard
• Frequently required to aseptically gown or wear other PPE on regular basis.

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 copied, 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.

Andelyn Biosciences is committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

Andelyn may require proof of COVID-19 vaccination prior to your first date of employment depending on whether your role would require performing under federal contracts on behalf of Andelyn. If required and in accordance with applicable federal guidelines, either proof of completion of an approved vaccine series will be required upon hire, or a religious and medical exemptions may be considered depending upon the specific job duties.