Associate Director, Site Automation OT Equipment

BioSpace; Village of Menands (NY); Sur place; USD 148 000 - 241 000; Plein temps

Résumé du poste

Regeneron seeks an Associate Director, Site Automation in Menands, NY to lead the automation team across manufacturing, labs, and facilities. You will drive cGMP automation quality systems, software change control, deviations investigations, and equipment qualification while collaborating with Manufacturing, QA, Engineering, and vendors.

The role requires a BS/BA in science/engineering/software, MBA/MS preferred, 10+ years in pharma automation, and proven leadership in cGMP environments.

Qualifications

• BS/BA in Science, Engineering, or Software; MBA/MS preferred.
• 10+ years of automated equipment experience in pharma/biopharma or regulated industry.
• 5+ years leading automation teams in a cGMP environment.
• Strong knowledge of cGMP quality systems and regulatory standards.

Responsabilités

• Lead the automation team by setting clear expectations and modeling compliance.
• Oversee the cGMP software administration program and lifecycle docs.
• Oversee investigation support for manufacturing deviations and automation issues.
• Lead projects on corrective actions and equipment performance improvements.
• Maintain budget forecasts and headcount plans for the department.
• Support vendor relationships and oversee equipment procurement and qualification.

Connaissances

Automation leadership

cGMP knowledge

Regulatory standards

Project leadership

Deviation investigations

Formation

BS/BA in Science/Engineering/Software

MBA or MS preferred

Outils

Automation control systems

Software change control

Description du poste

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director, Site Automation to join our Operation Technology Small Equipment, supporting either Red Mill (Bulk Manufacturing) or Temple Lane (Internal Fill Finish) Site. This role is providing technical and automation leadership across manufacturing, testing laboratories, and facilities operations. In this role, you will supervise a team and drive accountability across cGMP automation quality systems, software change control, corrective actions, and equipment procurement and qualification while collaborating with Manufacturing, Quality Control, Engineering, and vendor partners.

When & Where

Location: Menands, New York

Work model/flexibility: Monday - Friday 8am - 4:30pm, onsite

Travel percentage: 5-10% to US & International travel

Discover Your Role

• Lead the automation team by setting clear expectations and modeling compliance; ensure adherence to all departmental policies and procedures
• Oversee the cGMP software administration program and automated system periodic evaluation program; ensure SOPs and Software Lifecycle Documentation remain aligned with current regulatory standards and guidelines
• Oversee investigation support for manufacturing deviations, lab testing anomalies, and issues related to automation, software, and hardware
• Lead projects related to corrective action and equipment performance improvement; ensure timely completion of all departmental projects, work orders, and quality management items
• Maintain budget forecast and compliance for the direct team; provide headcount forecasts for department growth to senior management
• Support vendor relationships and ensure compliance with approved suppliers; oversee equipment procurement, commissioning, and equipment and software qualification activities

This Role Requires

• BS/BA in Science, Engineering, or Software Programming, or equivalent years of direct experience with automated control systems or equipment in lieu of degree
• MBA, MS or advanced degree preferred
• 10+ years of experience with automated equipment in the pharmaceutical or biopharmaceutical industry or related regulated industry, including at least 5 year of direct experience in the design, installation, maintenance, and/or troubleshooting of automated control systems
• Demonstrated experience leading or managing automation teams in a cGMP regulated environment
• Strong working knowledge of cGMP quality systems, software change control processes, and regulatory standards applicable to automated systems
• Experience with vendor management and approved supplier compliance programs preferred

We are committed to building a workplace with an inclusive culture.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$147,800.00 - $241,200.00