Location: Las Piedras, PR, US
Company: Johnson & Johnson
McNeil LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Senior Manager, Mathematical Sciences reporting to the Technical Operations Team, for the facility located in Las Piedras, Puerto Rico.
McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D, MOTRIN® IB, PediaCare® upper respiratory medicines for infants and children, ST. JOSEPH® Adult Regimen Aspirin, and SUDAFED® nasal decongestants. McNeil-PPC, Inc. entered into a consent decree, or agreement, with the agency that governs certain manufacturing operations to help ensure quality and compliance. Now is an exciting time to join our business, as we focus on reaffirming the integrity of our iconic brands that are staples of households worldwide. Whether you view this opportunity as a potential career accelerator here, within the J&J's Family of Companies or beyond, or whether this is your entry to the J&J's Family of Companies, we invite you to join us…. Creating the future of McNeil.
The Senior Manager, Mathematical Sciences will be the Subject Matter Expert (SME) in the use of non-clinical mathematics/statistics, identifying and implementing industry best practices and designing a sustainable, measurable program for enabling the organizational capabilities associated with the appropriate use of mathematics and statistics. With her/his peers, she/he will be the liaison within technical operations application of statistical/mathematical approaches for innovation, development, commercialization, validation and life-cycle management of drug product manufacturing and packaging processes including solid (e.g., tablets, caplets) and non-solid (e.g., solutions, suspensions, ointments) dosage forms. The incumbent must be able to interact with all associates at all levels. The role is expected to design and deliver broad training and effectively mentor individuals to install a culture of evidence based decision making and risk management. The incumbent will be expected to provide the technical leadership to facilitate business decisions through the appropriate use of mathematics/statistics to support both internal and external projects. The role will serve as the mathematics/statistics Subject Matter Expert for numerous committees (e.g., Material Evaluation Team, Stability Review Committee, Technical Review Committee, Validation Review Committee, Product Family Ownership Committee).
The Senior Manager, Mathematical Sciences will be the single point of contact for the supply chain (Tech Ops, Manufacturing, Q&C, etc.) in the PR region (Las Piedras, Gurabo) for the appropriate use of mathematics/statistics to solve technical issues at our internal plants as well as our J&J and external manufacturing partners. Ensures consistency throughout the supply chain by designing and delivering the capability enabling program for the use of mathematics/statistics through broad based skill development and targeted mentorship. Includes the review of statistical software packages and procedures for appropriateness. Able to collaborate across the entire organization to influence positive project outcomes. Able to construct and deliver sound scientific concepts, evidence, assessments of risk and impact, and logical arguments to management, regulatory agencies and cross-functional partners. Able to work with project teams (including investigations) to select appropriate study design and data collection plans to meet defined objectives. Actively contributes to project teams (including investigations) to identify scientifically appropriate data collection instruments to ensure final analysis accounts for unavoidable confounding factors and uncertainty, and statistical conclusions are defendable. Able to develop creative/alternative analysis strategies for real-world applications. Actively maintains relationships within J&J PE community to ensure incorporation of best practices and tools are utilized at McNeil and at the enterprise level. Able to contribute via ad hoc membership for numerous governance committees. The ideal candidate will have a demonstrated ability to facilitate continuous organizational growth in mathematics, statistics and/or computational/quantitative sciences and the ability to stay current with industry trends through involvement with external/professional organizations.
All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.
A minimum of a Bachelor’s degree in Statistics or related Quantitative Sciences with ten (10) years’ experience or Master’s Degree in Statistics or related Quantitative Sciences with eight (8) years’ experience is required. A PhD Degree in Statistics or related Quantitative Sciences is preferred. Working experience with applied non-clinical statistics for manufacturing is required. Experience in Quality Assurance or Technical Operations is preferred. Experience with Pharmaceutical solids, liquids and packaging is ideal. Knowledge of cGMPs and pharmaceutical manufacturing processes is required. Supervisory experience is strongly preferred. Expertise with ANOVA, regression, variance components analysis, capability analysis, sampling plans, control charts, exploratory data analysis and experimental design is required. Must be familiar with mixed effects modeling and multivariate analyses and have the ability to rationalize and communicate the difference between statistical and practical significance. Proficiency with MS Office is required; with statistical software such as SAS, JMP, Minitab, or R. Minitab is strongly preferred. Demonstrated strong communication/negotiation skills to interact with internal and external partners. Demonstrated strong facilitation and organizational skills. Excellent oral & written communication skills, in Spanish and English. Must have understanding of team and organizational dynamics, budgets and timeline. Experience and demonstrated results managing and resolving conflict, and overcoming resistance. Ability to develop successful project management process, project assessment and risk assessment. The physical requirements of this position includes, stand up facilitation for partial or full day long facilitation as needed in a general office environment. Able to work extra hours and to respond to emergency calls that require returning to the company. Able to support other departments or projects according to business needs.
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Primary Location:North America-United States-Puerto Rico-Las Piedras
Organization: McNeil Healthcare LLC (7598)
Relocation: Eligible No
Job Function: Operations (Generalist)