Principal Scientist, Analytical Development

Principal Scientist, Analytical Development

Summary:

Catalent Cell and Gene Therapy is looking to recruit a Principal Scientist, Analytical Development to join our growing 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.

The role involves developing robust analytical methods for gene therapy products, with a focus on Quality by Design principles and regulatory compliance. The Principal Scientist will report to the Senior Director of Analytical Development and is expected to have extensive experience in analytical method development and validation. Responsibilities include authoring reports, utilizing statistical tools for method optimization, leading experimental designs, and ensuring compliance with regulatory guidelines. The candidate must possess strong analytical skills, proficiency in statistical data analysis, and effective communication skills to present findings to both technical and non-technical audiences.

The Principal Scientist- Analytical Development will report to the Senior Director, 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:

• Lead the design, execution, and analysis of experiments using Quality by Design (QbD) principles and statistical tools such as DOE to support method development and optimization.
• Author analytical development reports, including summary and robustness documentation, ensuring clarity and regulatory alignment.
• Provide technical leadership and guidance on experimental design and method validation in accordance with ICH and FDA regulatory requirements.
• Troubleshoot and remediate analytical methods while maintaining compliance with applicable regulations and site SOPs.
• Collaborate cross-functionally to support method lifecycle management and successful transfer to quality control.
• Effectively communicate complex scientific and statistical data through reports, presentations, and to non-technical stakeholders.
• Act as a subject matter expert on regulatory guidance and analytical method development for gene therapy and related products.
• Mentor and train junior team members within the Analytical Development department.
• Propose and evaluate new technologies to enhance method performance and streamline development processes.
• Represent the company in customer and regulatory interactions, providing defensible interpretations of guidance and resolving complex technical discussions
• Other duties as assigned.

The Candidate:

• Ph.D. in Biotechnology, or related field with at least 8-10 years of laboratory experience, preferably in an industrial setting, OR
• MS in Biotechnology or related field with at least 12 years of industry laboratory experience, OR
• B.S/B.A. in Biotechnology, or related field with at least 15 years of industry laboratory experience.
• Ability to communicate in written and verbal English required.
• Ability to formulate complex and comprehensive materials such as authoritative reports and/or to make formal presentation required.
• Detail oriented with ability to work effectively under high pressure with multiple deadlines.
• Understanding of biochemical and molecular assays (ddPCR, qPCR, ELISA etc.) cell-based assays (infectivity, potency etc.), separation assays (HPLC, CE-SDS, etc. ) is a plus.
• Experienced in all aspects of method lifecycle support and regulatory strategy development, with preferred experience in writing or contributing to IND and BLA submissions to support regulatory milestones.
• Proficient in the operations of a computer with MS Office, specifically MS Excel and MS Word, as well as programs for multiple pieces of laboratory equipment.

The anticipated salary range for this position in Maryland is $140,000 - $180,000 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 .