Regeneron Pharmaceuticals, Inc

Process Development Associate, Synthetic and Bioconjugation Scale-Up Technologies (SBST) (1 of 2)

Regeneron Pharmaceuticals, Inc$70K — $110K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in chemical/biochemical engineering or related field with 0-3 years of relevant experience.
  • Hands-on experience with bioconjugation processes and upstream and downstream purification techniques.
  • Knowledge of quality assurance principles, particularly GMP, and technology transfer documentation.
  • Familiarity with analytical characterization tools like HPLC, mass spectrometry, and UV spectroscopy.
  • Previous work with bioconjugates, especially involving antibodies, is highly preferred.

Responsibilities

  • Design and develop scalable, GMP-ready bioconjugation and purification processes.
  • Collaborate with analytical teams to establish characterization techniques.
  • Evaluate processes and set developmental goals within cross-functional teams.
  • Ensure compliance with lab and environmental safety regulations.
  • Use statistical design of experiments to optimize bioconjugation and purification processes.
  • Provide technical assessments for external manufacturing and assist in process transfers.
  • Research and develop new technologies to enhance process control and analytical methods.

Benefits

  • Collaborative work environment focused on innovation and scientific advancement.
  • Opportunities for professional development and mentorship.
  • Engagement with cross-functional teams to enhance learning and exposure.
  • Contributing to the advancement of new drug modalities for patient care.
Full Job Description

Regeneron's Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking a hardworking and dynamic Process Development Associate for its new Synthetic and Bioconjugation Scale-up Technologies (SBST) group. In this exciting new role, you will develop conjugation and purification processes for bioconjugation of proteins to a diverse range of small-molecules. You would work in close collaboration with cross-functional teams for process development and optimization using the principles of Quality by Design (QbD) to make the processes suitable for GMP production. This role also involves process scale-up and technology transfer of manufacturing related workflows to Contract Development and Manufacturing Organizations (CDMOs) or Regeneron based manufacturing suites to ensure timely and reliable entrance to the clinic through product commercialization.

A typical day in the role of Process Development Associate II might include:
  • Working at the bench to design and develop scalable, robust and controlled GMP-ready bioconjugation and purification processes.

  • Collaborating with analytical groups within or outside the organization to establish supportive analytical characterization techniques.

  • Discussing plans and data in cross functional teams to evaluate processes and determine developmental goals and ensure integrated program success.

  • Proactively complying to lab safety and environmental safety expectations of both Regeneron and regulatory bodies such as Food and Drug Administration (FDA), Department of Transportation (DoT), etc.

  • Using statistical design of experiments (DOE) to optimize bioconjugation processes including conjugation reactions, purification operations, and analytical characterization.

  • Partnering with External Manufacturing group and other key partners at Regeneron’s IOPS organization to provide technical assessment of CDMO’s intended for GMP production and successfully transferring processes with immediate, first-time success.

  • Researching, identifying, and developing new technologies to improve processes, generate predictive process models, and pioneer novel at-line/in-line process analytical technologies (PAT) to ensure robust and controllable bioconjugation and purification processes.

  • Authoring robust technology transfer documentation and supporting production with onsite presence during scale-up/GMP manufacturing activities.

  • Analyzing and presenting data in a clear and cohesive manner to a broad audience facilitating data-driven decision making.

  • Authoring, reviewing, or providing domain expertise for publications, reports, tech transfer documents, regulatory support documents and patents.

  • Being a responsible lab citizen by ensuring timely maintenance of lab equipment, keeping the lab tidy and organized and proactively planning for lab resources.

  • Coaching and mentorship of junior team members of the organization as needed.

This Role May be for You if You:
  • Enjoy working in the lab to advance exciting new drug modalities to patients.

  • Have strong initiative and aim to complete challenging tasks and learn new technologies.

  • Have a strong fundamental understanding of various protein purification and technology transfer principles
  • Are capable of multi-tasking and working both independently and in a collaborative environment involving cross-functional teams.

  • Have excellent interpersonal, verbal and written communication skills.

  • Can think critically and demonstrate problem-solving skills.

This role requires a Bachelor’s + 0-3 years relevant experience in chemical/biochemical engineering or a related field. Experience with antibodies in the bioconjugates space is highly preferable. Hands on experience with bioconjugation processes (lysine-based, cysteine-based, site-specific etc.) with practical knowledge of downstream purification techniques such as chromatography, ultrafiltration/diafiltration, membrane technologies etc. is preferred. Experience with a variety of analytical characterization tools such as electrophoresis, mass spectrometry, high-performance liquid chromatography (HPLC), UV spectroscopy, etc. is preferred.

Salary Range (annually)

$70,300.00 - $110,100.00

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.

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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.

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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.

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Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ

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