Regeneron Pharmaceuticals, Inc

Director QA Operations

Regeneron Pharmaceuticals, Inc • $172K — $286K *
Rensselaer, NY 12144In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor’s degree in Life Sciences or related field, or equivalent combination of education and experience.
  • Minimum of 12 years of experience in Quality Operations, Quality Management or a manufacturing role in the drug substance/biologics sector.
  • Experience in overseeing production processes such as cell culture, chromatography, and aseptic dispensing.
  • Strong leadership and team management skills, with the ability to develop and inspire others.
  • Familiarity with FDA and International Regulatory Body requirements.

Responsibilities

  • Build and execute a business strategy translating corporate goals into departmental objectives.
  • Lead and maintain a high-performing QA team, ensuring alignment with other functional groups.
  • Set performance standards and conduct evaluations while developing direct reports.
  • Oversee quality training for staff to support operations and resolve production risks.
  • Direct cross-functional project teams, ensuring timely completion within budget and quality standards.
  • Interface with senior management to report on project milestones and resource needs.
  • Provide leadership to ensure a constant state of inspection readiness for the manufacturing areas.

Benefits

  • Opportunity to work with cutting-edge drug substance manufacturing processes.
  • Collaborative work environment with cross-functional team leadership.
  • Potential for career development and training opportunities within the organization.
  • Engagement in ensuring compliance with crucial regulatory standards.
  • Participation in continuous improvement initiatives within production operations.
Full Job Description

Director, Quality Assurance to provide the quality support and oversight for drug substance manufacturing operations at the Regeneron Drug Substance (DS) facility.  The position is responsible for the QA DS team overseeing any or all of the following production processes: cell culture, centrifugation, chromatography, ultrafiltration/diafiltration (UFDF), and aseptic dispensing of bulk drug substance.  The director will provide the leadership, direction, and the overall Quality oversight of the manufacturing area ensuring they meet current FDA and International Regulatory Body requirements.

When & where:

  • Location: Rensselaer, NY

  • Work model: Monday-Friday, 8am-4:30pm

Discover your role:

  • Build and execute a business strategy that translates vision and corporate goals into departmental objectives

  • Builds and maintains a high performing team of managers, providing effective alignment and communication with functional groups at the site and at other manufacturing sites, to successfully deliver on all commitments. Sets the course for the future- defines priorities, goals and objectives for quality team

  • Provide direction, set performance standards, evaluate, develop performance and inspire direct reports

  • Ensure quality floor staff are appropriately trained to support plant operations, ensuring risks are identified and resolved. Responsibilities include in-process testing oversight, line clearance checks (as necessary), batch record review, return to service requirements have been met and quality-on-the-shop-floor responsibilities of first response to product quality issues in production

  • Provide career development and training advice.  Provide regular feedback to direct reports on company and departmental operations

  • Directs the activities of resources, both internal and outside contractors/vendors, with similar technical or functional responsibilities

  • Lead cross functional teams and manages the deliverables for the assigned projects.  Drives projects through completion within timeline, quality and budgetary constraints.  Interfaces with senior management to report on project and program milestones and to present project needs

  • Provides escalated response for Quality and Compliance issues on the manufacturing floor and assures that decisions are made at the proper level and with the appropriate insights.

  • May provide review and final QA approval of deviations, and other quality events; protocols/reports; change documentation, SOPs; master batch record approval

  • Ensures product, facility, and equipment holds are placed when batch, equipment or system integrity is questioned

  • Responsible for representing the Company and directly interfacing with auditors during regulatory body inspections

  • Ensures periodic informal audits are completed in production

  • Leads teams for tracking of quality activities, metrics, CAPA tracking, etc. Reports metrics and assesses data trends to work with operating departments to facilitate process improvements

  • Develops or supports procedure and process development for continual improvement of cell culture operations, centrifugation/harvest, chromatography, UFDF, viral clearance, aseptic dispensing, filling batch records, and segregation/hold process

  • Provide leadership and direction to the manufacturing and support area departments to ensure a constant state of inspection readiness

  • Requires the ability to influence others to achieve results and to challenge the status quo

This role requires:

  • Bachelor’s degree in Life Sciences or related field, or equivalent combination of education and experience, and a minimum of 12 years experience in a Quality Operations, Quality Management or manufacturing role, in a late stage or early stage start-up Drug Substance/biologics company

Salary Range (annually)

$172,200.00 - $286,900.00

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

Explore Job Opportunities and Growth

Regeneron offers a variety of job opportunities that encourage professional growth and personal achievement. Whether you're seeking an entry-level position or a more senior role, you will find a path that aligns with your career ambitions and skills. Our supportive culture emphasizes leadership development and diversity training, ensuring every team member can thrive.

Internship Programs

Kickstart your career with a Regeneron internship. Our programs provide invaluable industry experience, mentoring from seasoned professionals, and opportunities to develop skills that are crucial in the biotech field. Interns at Regeneron gain hands-on experience, contributing to projects that matter.

Benefits and Culture

Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

Networking and Professional Development

Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

Join Our Team

Discover the impact you can make in a career at Regeneron Pharmaceuticals, Inc. Search for open positions that match your skills and interests. We are continuously hiring and looking for passionate, curious, and innovative team players.

Stay Connected

Keep up to date with the latest at Regeneron by following our careers blog. Gain insights from the experts and learn more about the exciting world of biotech at Regeneron Pharmaceuticals, Inc.

Prepare for Your Interview

Ready to join us? Prepare your resume and refine your interview skills to become part of a company that’s dedicated to changing lives. Personalize your job search and get tailored job alerts directly to your inbox, so you never miss an opportunity to be part of our team. At Regeneron Pharmaceuticals, Inc, your career is poised for tremendous growth and innovation. Explore the opportunities today and be part of a team that’s shaping the future of biotechnology.
Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Pharmaceuticals & Biotech
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ
REGN
* Ladders Estimates

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