Catalent is looking for an Associate Scientist III - Immunoassay
to support our Process Development and Analytical Development team at our facility in Gaithersburg, MD.The Associate Scientist III - Immunoassay
role is responsible for supporting the development of new test methods via cell-based and immuno-based assays to help ensure quality and composition of newly developed Cell & Gene Therapy products and therapies.Catalent Cell & Gene Therapy
is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.The Role
- Develop, optimize, qualify, and transfer ELISA assays with the intention to characterize gene therapy products and related biologics.
- Demonstrate an understanding of immunoassays for the purpose of Identification, Potency and Quantitative measurement of target analytes, biological impurities such as process impurities, and host cell proteins.
- Understand and conduct studies for method development/evaluation, qualification/validation, transfer according to scientific justifications and current regulatory guidance (e.g. ICH, FDA, EMA).
- Generate accurate and high-quality documentation such as protocols, reports, standard test methods, and SOPs.
- Actively engage with other members of the team and supporting departments.
- Perform data analysis, interpret data, and present findings.
Why you should Join Catalent:
- Bachelors Degree in a Life Science discipline or related field and 5+ years of relevant experience is required OR a Master's Degree in a Life Sciences discipline or related field and 3+ years of relevant experience.
- Experience with ELISA and other immunoassays is required
- Method Development or Assay Development experience is preferred
- Experience in biologics, Gene Therapy, Cell Therapy, etc. is preferred
- cGMP/GLP experience is preferred
- Competitive medical benefits and 401K
- 19 days of PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to firstname.lastname@example.org for us to investigate with local authorities.