Senior Scientist, Non-Clinical Senior Statistician

Summary

Catalent Cell & Gene Therapy is looking to recruit a Senior Scientist, Non-Clinical Senior Statistician to join our growing team in Baltimore, MD.

A Non-Clinical Senior Statistician is needed to support Catalent Cell, Gene and Protein Therapy teams for all aspects of statistics in development and manufacturing of pharmaceutical clients' products, processes, and analytical methods. Responsibilities include identifying opportunities for standardization of internal statistical methodologies applied to drug development, drug substance and drug product manufacturing.

The Senior Statistician will be partner of project teams, management, and key stakeholders in the organization in providing statistical support. She/He will continually develop new statistical concepts, influence internally and externally to adopt rigorous statistical approaches which have organizational impact. Specific area of involvement include (but not limited) statistical design of experiments, process and method development and validation/transfer, control strategies applications, process capability and control evaluation, sample size calculation, stability design and analysis, collaboration and review of regulatory specifications, investigation of Out-of-Specification and Out-of-Trend results, developing and providing statistical training. Strong collaborator who will work effectively cross functionally. Some travel to relevant sites will be needed to evaluate capabilities and implement projects.

Catalent Pharma Solutions is the leading Contract Development and Manufacturing Organization (CDMO). Within Catalent, Catalent Biologics is a fast-growing business focused on providing innovative technologies and product solutions to our clients and patients. Process and analytical development (PD) laboratories for protein therapies located in Madison, WI and Bloomington, IN include stat-of-the-art labs for clinical and late phase development. The Gene Therapy Development teams at Baltimore-BioPark focus on viral vector process and analytical development. Cell Therapy PD is located in our Cell Therapy campus in Gosselies near Brussels. For process and method transfer, the teams collaborate with scientists from Manufacturing Science and Technology (MS&T) and Quality Control (QC). Leveraging our differentiated technology portfolio, world class manufacturing capability, and integrated services across the Catalent network; Catalent Biologics is positioned to drive significant growth for Catalent.

The Role:

• Applies advanced theoretical knowledge and contributes to the development of new principles and concepts.
• Provides statistical expertise, study design, and analysis and communicates data driven decisions for biologics process improvements, Drug Substance and/or fill finish process understanding, process and method development, transfer and validation, and stability studies in collaboration with scientists.
• Establishes control strategies for manufacturing processes and analytical assays, evaluates process control and capability, and determines appropriate regulatory and release specifications.
• Maintains statistical expertise by learning new methodologies, choosing which methods to use in analysis, and justifying methods selected.
• Communicates study results and statistical concepts in one-on-one meetings, oral presentations, internal reports, and presentations at professional associate meetings.
• Serves as the statistical lead and effective member of diverse cross functional internal and client teams providing statistical guidance and problem-solving acumen on wide range of projects.
• Develops, validates and maintains user-friendly statistical tools, scripts, and applications (R packages, Shiny applications, and Markdown templates…).
• Supports improvement of data collection and management to enable quick and reliable data analysis.
• Knowledge of analytics and data visualization platforms.
• Strong interpersonal skills (job requires significant customer/peer/management interaction) and ability to work effectively on teams.
• Other duties as assigned.

The Candidate:

• Bachelor’s degree in Statistics, Mathematics, Data Science, or related scientific field with +7 years of relevant experience OR Master degree in the above-mentioned areas with +3 years of relevant experience OR PhD degree in the above-mentioned areas with +2 years of experience.
• Experience in biologics drug substance development and manufacturing.
• Experience of SQL, VBA, PowerBI is a plus.
• Proficiency in the use of statistical software (e.g. SAS, R, JMP, Minitab, etc.).
• cGMP experience preferred.
• Demonstrated written and oral skills. Fluent in English. A second language is desirable (e.g. French, German)
• Ability to work independently within a team environment.
• Demonstrated interpersonal skills to build relationships, act as change agent, and adapt to rapidly changing organizational and business needs.

Why you should join Catalent:

• Potential for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross-functional exposure to other areas within the organization
• Medical, Dental, Vision, and 401K are all offered from day one of employment
• Employee Stock Purchase Plan
• 19 days PTO and 8 paid holidays

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.

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