GENERAL DESCRIPTION
Andelyn Biosciences is seeking a motivated Metrology Supervisor to join our growing team. The Metrology Supervisor will be responsible for managing and coordinating group activities including equipment maintenance, repair, and validation. This role also includes developing equipment validation plans, ensuring the appropriate resources are available to complete them in the required time frame, and writing/reviewing documents in support of the change control process. Secondary responsibilities include managing the receipt and shipment of equipment, managing outsource calibration by vendors, preparing deviation documentation, supporting client audits, representing Metrology in meetings, and all other tasks required in supporting these primary responsibilities. The Metrology Supervisor is responsible for maintaining proper staffing levels, ensuring staff is appropriately trained, addressing personnel matters and escalating issues to management when necessary.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
1. Anticipating problems and removing obstacles to enable staff to perform tasks as assigned.
2. Managing and influencing people's indirect or lateral support structure.
3. Cultivating a diverse and collaborative team environment. Utilizing clear and concise communication to deliver high productivity and contribution to the success of department goals.
4. Mentoring and professional development of staff,
5. Communicating procedure updates to equipment users on new equipment.
6. Hiring and participating in the development and related personnel processes.
7. Exercising crucial people skills.
8. Operating within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF.
9. Maintaining compliance with applicable regulatory requirements for cellular and gene therapy products.
10. Performing in accordance with established policies, procedures, and techniques that require training, common experience, or working knowledge related to the tasks performed.
11. Working to specific measurable objectives requiring operational planning skills with little direct supervision.
12. Overseeing the equipment calibration program, including performing calibrations.
13. Creating and reviewing department SOP’s, risk assessments, and equipment validation protocols.
14. Identifying root causes for equipment failures
15. Taking budgetary responsibility.
16. Participating in audits.
17. Taking responsibility for inspection outcomes.
18. Propelling timelines and development through broad influence.
19. All other duties as assigned.
REPORTING RELATIONSHIPS:
Reports to: Associate Director, Metrology – Andelyn Biosciences
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
1. A relevant four-year degree (preferably science-related).
2. 5-6 years of experience in a related field.
3. Experience in highly regulated field preferred.
4. Strong computer skills with experience in Microsoft Office products.
5. Excellent communication skills, both written and verbal, in combination with strong interpersonal skills and demonstrated technical writing skills.
6. Strong attention to detail.
7. Exercise discretion, judgment, and a high level of integrity.
MINIMUM PHYSICAL REQUIREMENTS
- Independently lifting up to 20-30 pounds occasionally (0-33% of the time).
- May require the ability to aseptically gown or wear other PPE on regular basis.
- Must be able to stand for extended periods of time.
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