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Associate Scientist I, 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.

Catalent Maryland Inc is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Catalent provides process development and GMP manufacturing services for Phase I - III clinical trials and commercial products. Catalent Maryland provides gene therapy and viral vector-based therapies to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a Catalent employee, you will actively contribute to delivering our services and products to customers and their patients.

This role is responsible for supporting the Process Development Stability Program within Catalent’s Analytical Development department, ensuring full compliance with Catalent Standard Operating Procedures (SOPs) and ICH guidelines. The individual in this position will play a key role in managing and executing stability studies, coordinating test submissions to internal and external laboratories, facilitating sample shipments, and drafting study protocols and reports.

Success in this role requires a solid understanding of analytical sample testing and stability study requirements, along with strong organizational and communication skills. The ability to work independently, as well as collaboratively in a fast-paced, team-oriented environment, is essential.

Analytical Development personnel must demonstrate excellent time-management abilities, prioritize tasks effectively, and maintain a strong commitment to quality, compliance, and scientific rigor. Although these studies fall outside the Catalent Quality System, the highest standards of compliance and Good Documentation Practices (GDP) are expected. Additional responsibilities may be assigned as needed to support departmental goals.

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.

This is a full- time, salaried, position: Monday – Friday, 8:00 am – 5:00 pm.

The Role:

+ Manage and maintain client samples, ensuring proper storage and inventory tracking

+ Draft and finalize stability protocols and reports (interim and final)

+ Perform stability timepoint pulls and aliquot samples according to established protocols and timelines.

+ Coordinate and submit samples to internal and external laboratories for testing

+ Oversee stability studies, ensuring samples are tested and reported within the allotted windows

+ Maintain accurate records and documentation in accordance with Good Documentation Practices (GDP)

+ Assist in troubleshooting and resolving issues related to stability studies

+ Other duties as assigned.

The Candidate:

+ Degree in Biology, Life Science or Chemical Engineering field (A.S. with 1-3 years’, or B.S. with < 1 year of experience)

+ The ability to work in team-oriented environment is essential, as this person will work closely with other members of Analytical Development, Process Development, QC, and Operations.

+ Previous experience working in Biotechnology or Pharmaceutical industry considered a plus

+ The position involves regularly sitting at a desk and working on a computer, standing, and walking for extended periods Must be able to lift to 15 pounds at times. The role requires the use of both laboratory and office equipment, with office-related tasks performed in a shared office space adjacent to the lab.

The anticipated salary range for this position in Maryland is $60,000 - $80,000 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why you should Join Catalent:

+ Defined career path and annual performance review and feedback process.

+ Diverse, inclusive culture.

+ Potential for career growth on an expanding team.

+ Cross-functional exposure to other areas within the organization.

+ 152 hours of paid time off annually + 8 paid holidays.

+ Medical, dental, vision and 401K benefits effective day one of employment.

+ Tuition Reimbursement.

**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 (https://careers.catalent.com/us/en) 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 [email protected] . 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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .