Associate Scientist III, Analytical Development

Associate Scientist III, Analytical Development

Summary:

Catalent Cell and Gene Therapy is looking to recruit an Associate Scientist III to join our growing Analytical Development team in Baltimore, MD.

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 individual functions independently and productively as an Associate Scientist III and is actively engaged in analytical method development within a dynamic project team. They display technical knowledge, initiative, and scientific commitment within the Analytical Development Group. They serve as an analyst and interact with Managers to ensure project goals are met.

The Associate Scientist III - Analytical Development will report to the Manager, Analytical Development.

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 on-site position, Monday Friday 8:00am-5:00pm

The Role:

• Develop and/or assist in the development of a variety of separations assays. This involves performing experiments to assess the performance characteristics and robustness of the method and troubleshooting the method as needed.
• Perform tech transfer of client-based assays to Catalent, including demonstrating the assays performance characteristics and documenting the method in a Catalent STM format.
• Analyze data and complete detailed reports with attention to detail.
• Qualify/validate methods to support Good Manufacturing Practices (GMP) testing.
• Troubleshoot and remediate analytical methods while ensuring regulatory compliance.
• Communicate scientific and statistical findings effectively through clear, concisely written reports and presentations.
• Communicate complex technical information to non-technical audiences.
• Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and site SOPs.
• Provide strong analytical and critical -thinking skills to troubleshoot and resolve technical challenges.
• Propose ideas and introduce new technology for process improvements with the goal of transfer to quality control.
• Other duties as assigned

The Candidate:

• Bachelors degree in engineering or a Life Science discipline with a minimum of 3 years of relevant experience OR Masters degree with at least 1 year of experience OR Ph.D. with 01 year of experience.
• Strong written and verbal communication skills, with the ability to develop detailed reports and deliver formal scientific presentations.
• Highly detail-oriented, with the ability to manage multiple deadlines in a fast-paced environment.
• Experience with separation methods such as liquid chromatography (LC) or capillary electrophoresis (CE) is required; familiarity with physiochemical assays such as DLS, AUC, or Mass Spec is a plus.
• Skilled in instrument operation, including maintenance, troubleshooting, and routine care.
• Proficient in MS Office applications (Excel and Word); experience with scientific documentation and technical writing.
• Experience supporting process technology transfers and familiarity with GMP operations preferred. Prior experience in the biotechnology or pharmaceutical industry is a plus.
• The ability to work in team-oriented environment is essential, as this person will work closely with members of the Process Development Team, AD, and QC Operations.
• Must be able to work at a computer and in a laboratory setting for extended periods, with the ability to lift up to 30 lbs, handle lab equipment with precision, and use appropriate PPE including gloves, goggles, and respiratory protection when required.

The anticipated salary range for this position in Maryland is $75,000 - $100,000 plus an 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 within an organization dedicated to preserving and bettering lives
• 152 hours of paid time off annually + 8 paid holidays
• Competitive salary with yearly bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision 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 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 .