Assoc Dir QC Technical Resources

Posted 5 Days Ago
Be an Early Applicant
Rensselaer, IN
143K-233K Annually
Senior level
Biotech • Pharmaceutical
The Role
The Associate Director of QC Technical Resources oversees the QC method validation and testing for incoming components, ensuring compliance with regulations. Responsibilities include directing QC Analysts, managing method transfers, providing analytical support across teams, and reporting to upper management.
Summary Generated by Built In

Regeneron is currently seeking an Associate Director/Director for our Quality Control (QC) Technical Resources Chemistry team for in-coming component testing, functional testing for combination drug products and raw material testing. This role will be responsible for bringing new components, determining the qualification and testing strategy, the oversight of the QC method validation of the methods for incoming components including visual inspection, functional testing, compendia testing, and method transfer to or from other internal sites, partners companies, and contract manufacturing companies.

As an Associate Director, a typical day might include the following:

  • Support filling operations for any technical support.
  • QC method validation and transfer processes.
  • Maintain open communications with scientist including internal, partner and contract manufacturing organizations.
  • Provide direction to Managers and scientist that support the method development, validation and transfer processes.
  • Coordinate with members of Process Sciences, Manufacturing, QC, Stability, and Business Ops to provide analytical support.
  • Oversee Project Management of Method transfer and validations.
  • Report progress monthly to upper management and reports any deficiencies.
  • Ensures QC Analysts receive proper training.
  • Ensures compliance with applicable cGMP regulations and SOPs, and safety standards are maintained.
  • Oversee investigations atypical and OOS test results as necessary.

This role might be for you if:

  • Looking to join a growing, diverse team that supports other QC teams to achieve continued growth and success.
  • Creative problem solver, effective communicator, goal and achievement motivated.
  • Have experience working with cross-functional teams for analytical development, support and challenges.
  • Customer service focused for internal and external partners.

To be considered for this position you must have a BS/BA in Science, Engineering, or related field, with experience in the pharmaceutical or biotech industry. Higher level degree preferred.

  • Associate Director – Requires 10+ years relevant experience
  • Director – Requires 12+ years relevant experience

External candidates only.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$142,700.00 - $232,900.00

Top Skills

Chemistry
Quality Control
The Company
HQ: New York, New York
15,000 Employees
Hybrid Workplace
Year Founded: 1988

What We Do

At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.

Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media.

An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.

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