Eli Lilly and Company
Responsibilities This position is responsible for leading site TS\/MS statistical support for current and new products and processes, driving and sustaining statistical thinking and appropriate use of statistical methodologies. Branchburg customers include TS\/MS, Analytical Sciences and Quality Control. Also serves as consultant for cross-site scientific project teams, regulatory filings and inspections, and management. Specific aspects include (but not limited to) statistically designed experiments, establishment of regulatory specifications, evaluation of control\/capability, process\/analytical method transfer & validation, sampling, stability, and development\/delivery of statistical training. Responsible for championing statistical and scientific excellence in support of manufacturing operations through the performance of the following duties: TS\/MS Support Provide guidance to Process Teams on process monitoring and statistical process control methodologies that are integrated with business practices. Evaluate process control and capability. Provide experimental design and analysis expertise to the TS\/MS laboratory for control strategy development, lab scale model transfer, process optimization and process troubleshooting. Provide statistical support for new product introduction\/technology transfer and process validation Develop statistical models and data analysis\/visualization tools as needed to improve quality and efficiency of manufacturing. Analytical Sciences Support Provide experimental design and analysis expertise to Analytical Sciences for analytical control strategy development, method optimization and troubleshooting. Be familiar with, recommend, and help implement modern analytical technology and tools to improve process understanding & troubleshooting, product quality, and cost reduction. Apply statistical analysis to bioassays, chromatographic & spectral assays and biophysical assays. QC Support Provide statistical expertise for analytical method transfer and validation. Apply appropriate statistical techniques to define regulatory specifications. Provide statistical guidance and analysis for product stability evaluation. Develop statistical modules and trending rules for monitoring analytical method performance. Cross-functional Support & External Interface Serve as statistical lead on scientific project teams. Represent Branchburg in cross-site scientific initiatives. Integrate with GSS toward the successful development and implementation of product control strategy, acceptance criteria and statistical process control methods. Interact with development scientists and molecule stewards, within and across Lilly sites. Influence internal and external customers and management, including to adopt a different point of view on difficult concepts. Propose and defend statistical approaches to regulatory agencies in both documentation and face-to-face interactions. Communicate results in one-on-one and\/or team meetings with key customers or external partners. Present released work at scientific conferences. Collaborate with scientists and statisticians on applied research projects related to modelling, experimental design, process control and\/or multivariate analysis. Develop and adminster training courses on statistical software\/methods and guidance in the appropriate use of statistical methodology. Basic Qualifications Advanced degree in Statistics or related science. M.S. with a minimum of 8 years experience or Ph.D. with a minimum of 2 years experience in a cGMP biopharmaceutical manufacturing and\/or process development (cell culture\/purification) environment. \u00a0 Additional Skills\/Preferences Demonstrated excellent problem solving skills. Demonstrated strong interpersonal skills (job requires significant customer\/peer\/management interaction). Demonstrated leadership skills, including prior supervisory experience. Demonstrated strong communication skills, both oral and written. Demonstrated ability to participate in and facilitate decision-making Additional Information Lilly 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.
Eli Lilly and Company
Website : http://www.lilly.com
Lilly makes medicines that help people live longer, healthier, more active lives. We were founded by Eli Lilly in 1876, and are now the 10th largest pharmaceutical company in the world. We have steadfastly remained independent, but not isolated. Across the globe, Lilly has developed productive alliances and partnerships that advance our capacity to develop innovative medicines at lower costs. Lilly is consistently ranked as one of the best companies in the world to work for, and generations of Lilly employees have sustained a culture that values excellence, integrity and respect for people.