Director Biotech Production

About the role

Join our core manufacturing leadership team, supporting the startup of our new biologics drug substance facility in Saratoga Springs, New York in an on-site role.

Responsibilities

• Leads the manufacturing team through facility start-up, setting the operating standards for a brand-new biologics plant
• Directs manufacturing of recombinant proteins according to approved protocols, regulations, and schedules across 2,000L and 10,000L bioreactor suites
• Translates corporate objectives into strategy, connecting floor-level performance to global IOPS goals
• Guides validation activities and equipment commissioning/qualification to ensure operational readiness
• Partners across Facilities, Process Development, Quality, and Regulatory to keep production running smoothly
• Builds and develops a high-performing team, embracing the ambiguity that comes with standing up a new site
• Tracks and trends key metrics to keep operations safe, compliant, and efficient
• Thrives on ownership, taking accountability for team performance and results from day one

Requirements

• Bachelor's in a physical or biological science or chemical engineering and 12+ years of biopharmaceutical/biotech work in a GMP production facility with 8-10 years (MA/MS), or 4-7 years (PhD)
• Demonstrated experience leading operational start-up for a clinical and commercial biologics manufacturing facility
• Experience working with industrial systems such as SCADA, DCS, MES, and PAT technologies; experience implementing these systems from an operational perspective is preferred
• Familiarity with other Industry 4.0 technologies and strategies is a plus

Qualifications

• Must be able to perform tasks that require regular presence on the production floor and entry into classified/controlled environments requiring gowning

Skills

• Strong leadership and team-building skills
• Excellent communication and problem-solving abilities
• Ability to manage multiple projects simultaneously
• Knowledge of biopharmaceutical/biotech production processes
• Experience with regulatory compliance and quality assurance

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 here.

Pay

$172,200.00 - $286,900.00 annually

Schedule

On-site