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Sr. Manager Quality Control - Chemistry (HPLC)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Rensselaer, New York
Start date
May 6, 2024

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Job Details

Regeneron is looking for a Sr. Manager QC (Quality Control) focusing on HPLC. This position supports QC Chemistry Day 1 operations. The Day 1 QC Manager will have direct oversight of an essential personnel team supporting a 24/7 operation. We are looking for someone that can balance the needs of the team as well as the needs of the business. The ideal candidate will help drive improvements in KPIs, metrics and team performance, with a focus on efficiency, continuous improvement and compliance. They will be responsible for routine operations and ensure all daily tasks, expectations and responsibilities are met.


As a Manager of QC, a typical day may include the following:

  • Ensure adherence to GMPs/regulatory requirements and help maintain an overall state of compliance.
  • Act as a QC Lab quality and compliance subject matter expert, driving risk-based actions and improvements, in alignment with the strategic direction of the QC organization and the company.
  • Foster collaboration and serve as a key member of the QC Chemistry group, providing quality leadership, guidance, and direction to achieve company and departmental goals.
  • Responsible for ensuring adherence to Quality Management Systems, ensuring robust investigations are performed and working closely with the QC investigations and technical resources teams.
  • Manage daily workflow and Identify, maintain, and manage overall compliance activities across the group.
  • Support investigations & corrective actions, and improvements to ensure thorough investigations, product impact assessments, identification of the root cause and implementation of corrective actions to mitigate recurrence.
  • Contribute to design control and risk management for data workflows, within the context of data integrity and data governance.
  • On-board, coach and mentor new team members. Coordinates with members of Manufacturing, Stability, and Business Ops to provide testing and analytical support
  • Manages QC Analysts, distributes work load, and monitors progress.
  • Oversees product testing and responds to excursions and executes on QC lab investigations, QC roadmap and strategy.
  • Review test reports, data and investigational test plans and help build a strong working relationship with key stakeholders and counterparts
  • Ensures QC Analysts receive proper training and guidance.
  • Attends meetings to keep informed of manufacturing priorities, and plans accordingly.
  • Ensures compliance with applicable cGMP regulations and SOPs.
  • Investigates atypical test results as necessary (OOS, OOT, LTIF, GLIFs).
  • Creates monthly testing reports, monitors and ensures adherence to performance metrics.
  • Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback and, performance evaluations.

This role might be for you if you:

  • Excel at critical thinking and problem solving.
  • Feel comfortable having challenging conversations and providing feedback.
  • Can encourage and motivate a team.
  • Can be a reliable, transparent, and trustworthy leader.
  • Can communicate clearly.
  • Can lead with compassion and understanding.
  • Are an experienced, results oriented leader, with a positive can do attitude and a sense of urgency to get things done.
  • Possess strong operating skills, decisions making, managing a diverse team, with good overall time and project management.
  • Strong communication skills with the ability to influence, and engage at all levels of the organization, fostering a collaborative and inclusive environment.
  • Are solutions oriented, with strong analytical, critical thinking and problem-solving skills.
  • Are proficient in managing multiple projects and activities to support the business.
  • Are comfortable working in a fast-paced, highly dynamic environment.
  • Can be adaptable and flexible, and a quick learner in support of continuous improvements and team culture.

To be considered for the Manager Quality Control you must be willing and able to work Monday- Friday, 8am-4:30pm. You must have a BS/BA in Life Sciences, or a related field, Chemistry and Biochemistry preferred. For various levels you must have the following:

  • Manager QC Chemistry : 7+ years of related experience
  • Sr. Manager QC Chemistry: 8+ years of related experience

Leadership experience is required. GMP experience is preferred. Level is determined based on qualifications relevant to the role.

#LI-MB1

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)

$104,300.00 - $199,000.00

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
US

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