Associate Director Quality Control

BioSpace; City of Rensselaer (NY); On-site; USD 145,600 - 237,600; Full time

Benefits offered by this job

Health and wellness programs

Fitness centers

Equity awards

Annual bonuses

Paid time off

Job summary

A leading life sciences firm in New York is seeking an experienced Associate Director of Quality Control. Responsibilities include overseeing quality control validations, ensuring compliance with regulations, and providing technical support. Ideal candidates will have over 10 years of experience in the pharmaceutical industry and a strong educational background in science or engineering. This full-time role offers a competitive salary range and comprehensive benefits.

Qualifications

• 10+ years relevant experience required for Associate Director
• 12+ years relevant experience required for Director
• Experience in the pharmaceutical or biotech industry preferred

Responsibilities

• Support filling operations for any technical support.
• QC method validation and transfer processes.
• Ensure compliance with applicable cGMP regulations and SOPs.

Skills

Creative problem solving

Effective communication

Goal and achievement motivated

Technical support expertise

Education

BS/BA in Science, Engineering, or related field

Job description

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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. Experience in gene therapy and cell therapy is a plus.

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. Previous management experience required. Higher level degree preferred.

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

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)

$145,600.00 - $237,600.00

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Internet News

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