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.
Key Technical/Leadership responsibilities include:
- 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.
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)
- 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
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status