Scientist, Analytical Development

Scientist, Analytical Development

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Research Triangle Park (RTP) facility is home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.

Catalent Pharma Solutions is Morrisville, NC is hiring a Scientist for the Analytical Development team. The Scientist, Analytical Development usually works independently, conferring with superior on unusual matters. This role may involve guiding laboratory technicians, assistants, or associate-level scientists. The assignments are diverse and require creativity and innovation, providing significant latitude for independent action and decision-making. The Scientist may lead projects and teams, assuming a technical leadership role. Additionally, the Scientist will act as a liaison to internal and external customers, updating them on the progress of analytical and product development activities, particularly in support of nasal and inhalation development programs. Compliance with divisional and site Environmental Health and Safety requirements is expected.

This is a full-time, salaried role. The core hours are Monday - Friday 8:00AM 5:00PM

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, and validate analytical methods (e.g., HPLC, GC, UV-Vis, FTIR) for raw materials, intermediates, and finished products.

• Design, execute, review, and interpret experiments to support product development and tech transfer activities

• Maintain laboratory equipment and ensure compliance with safety, quality, and regulatory standards (e.g., GMP, GLP, ICH guidelines).

• Resolve technical issues and drive the completion of investigations that affect the technical scope, as well as recommend options to resolve the issue.

• Perform analytical testing to support formulation development, process development, and stability studies. Work independently with supervision on an 'as needed' basis and recognize key issues likely to affect successful and/or timely completion.

• Participate in Lean Six Sigma projects and drive continuous improvement.

• Support product development and technology transfer activities, including drafting and reviewing analytical methods, protocols, and reports.

• All other duties as assigned.

The Candidate:

• Bachelors degree in a physical, chemical, biological, engineering, or pharmaceutical science required.

• With a Bachelors, 6+ years of experience in cGMP laboratory environment (or) with a Masters, MS 4+ years of experience in cGMP laboratory environment (or) with a PhD, 2+ years of experience in cGMP laboratory environment is required.

• In-depth knowledge of analytical development of pharmaceuticals; preferably inhalation and nasal dosage forms, in a cGMP environment.

• Excellent written and verbal communication skills are preferred, and experience in a client-facing role is highly preferred. Demonstrates strong problem-solving and critical thinking skills, with the ability to work independently and as part of a fast-paced environment.

• Understanding of ICH guidelines and USP compendial requirements highly desired.

• Experience with Chromatographic techniques (such as HPLC, UPLC, or GC) required.

• Prior experience with conducting method development, method transfer, and method validation, with an understanding of the life cycle of pharmaceutical products and regulatory requirements. Experience with nasal and inhalation product methods is a plus.

• Individual may be required to sit, stand, walk regularly, and occasionally lift 0-40 pounds. Specific vision requirements include reading written documents and frequently using a computer monitor screen. May require the use of a respirator.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• Positive working environment focusing on continually improving processes to remain innovative

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• 152 Hours + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• Community engagement and green initiatives

• Generous 401K match

• Company match on donations to organizations

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement Let us help you finish your degree or start a new degree!

• WellHub program to promote overall physical wellness

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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.

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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE .