The individual in this position provides a critical link between R&D and commercialization of animal health products. You’ll be an essential and accountable partner of CM&C teams, influencing scientists, management and key stakeholders in the organization.
During formulation development, process development and analytical method development, you will mentor R&D scientists in concepts including statistical thinking, design of experiments and Quality by Design tools and principles. You will provide technical (computational) support, as appropriate.
This role will suit a driven, self-motivated, and experienced statistician. You must have a strong technical knowledge of statistics and be proficient in the use of statistical software.
Basic Minimum Qualifications:
- PhD in statistics with 5 or more years experience in pharmaceutical process and analytical development OR MS degree in statistics with 7 or more years experience in pharmaceutical process and analytic development
- Proficient in applying common statistical software (e.g. JMP, SAS, R)
- Knowledge of GMP expectations for CM&C development
- Knowledge and experience with QbD and DOE in pharmaceutical development
- Experience as a consultant statistician who has taken a leadership role in a multi-disciplinary team, supporting product submissions utilizing QbD principles, and is familiar with relevant guidance and specification expectations (in US/EU)
Key Technical/Leadership Responsibilities:
- Work proactively with development teams to identify appropriate solutions to business and research problems. Promote and facilitate the use of statistical thinking, data-based decisions, and experimental design during technical development, scale-up, and transfer of new processes and analytical methods for active ingredients and products.
- Collaborate with Manufacturing & Quality (M&Q) statistical and technical scientists. Assist R&D scientists to properly integrate Quality by Design (QbD) principles and life cycle process validation into analytical and process development.
- Identify and utilize right-sized statistical methods (DOE, multivariate analysis, modelling, etc.) to deliver individual objectives in a high-quality, cost-effective manner. Assist CM&C teams with IPC and specification identification and rationale.
- Manage and meet timelines for statistics deliverables.
- Shape and influence the internal and external CM&C statistical landscape by actively contributing to Elanco Communities of Practice. Actively participate as a development representative on the Elanco Specifications Review Board.
- Upskill the organization on the application of statistics by providing coaching, mentoring and training of non-statisticians as required on the appropriate use of statistical methodologies for their business processes. Effectively communicate statistical principles and approaches to associates without a statistical background.
- As appropriate, author and review sections of regulatory submission documents. Participate in the response to health authority questions. If required, participate in product related or scientific meetings with health authorities.
- Create a positive work environment that is in alignment with the company objectives. Participate in and promote a collaborative environment with an entrepreneurial mindset. Effectively communicate with project team members, management, M&Q customers, and external collaborators.
- Provide information to facilitate accurate and timely project and budget forecasts.
- In conjunction with the Senior Director, lead resolution of issues and ensure effective prioritization.
- Experience in animal health
- Experience in developing and delivering statistical training to scientists and engineers.
- Experience in pharmaceutical manufacturing and/or quality control labs
- Knowledge of Near-Infrared Spectroscopy, Process Analytical Technology and associated modeling/software
- Experience working in global and agile teams
- Experienced in applying QbD principles to biopharmaceutical and/or vaccine development
- Knowledge of USDA expectations for CM&C development
- Relocation to an Elanco RD site in the US or EU is possible