Manager, R & D - Analytical

Position Summary

The Analytical Manager of R&D will provide both strategic and tactical leadership as part of the R&D team. The Analytical Manager of R&D will participate in strategic and technical planning on the product development pipeline and will be responsible for establishing analytical timelines, executing the plan, and monitoring the results. The incumbent will be responsible for building, leading and developing a group of analytical scientists involved in the overall product development cycle. The activities of the group include, but not limited to method development: validation, Development support, product compatibility and scale up studies, and tech transfer to internal and external customers. The individual will be responsible for implementing policies and technical and problem-solving support to other groups and be a liaison for the research and Development Team and other departments.

Job Responsibilities

• Provides analytical scientific and technical contribution to the product development planning team.
• Performs analysis as needed to meet business needs.
• Defines analytical development/validation plans with durations for each project within the pipeline.
• Optimizes efficiency of the working environment of the analytical group.
• Identifies new technologies and the resources required to implementation process.
• Provides work assignments with communication of the expected timeline.
• Monitors projects progress against the timelines.
• Provides day to day mentoring to analytical scientists.
• Ensures training of the analytical group is complete.
• Acts as a R&D leader in formulating and implementing policies that meet current and upcoming compliance and operational needs.
• Pays specific attention to equipment operating practices and conditions to minimize equipment down time, lower maintenance costs, reduce time to run project and repeat of work.
• Responsible for safety of analytical R&D staff and visitors.
• Provides troubleshooting support other groups such as QC as needed.
• Assumes other responsibilities as assigned by upper management.
• Serves as a liaison for the Research and Development Team and other departments.
• May handle hazardous waste as required to dispose of laboratory solutions. Basic RCRA training is required for all employees of the laboratory and continuing RCRA training will be performed on an annual basis. New hires may only handle hazardous waste prior to attending RCRA training if they are under the supervision of a RCRA trained employee. RCRA training will be attended within six (6) months of hire.
• For personnel performing additional hazardous waste activities beyond routine discarding of hazardous waste into satellite containers, additional training is required per SOP-QC-000034 and documented on FORM-000904.

Education Requirements

Bachelor's degree in Chemistry or related scientific discipline with approximately 7 years industry experience with at least 5 years' Pharmaceutical Industry experience in R&D and 2 years managerial experience required. Master's Degree Preferred.

Experience Requirements

• Ability to lead and develop individuals within a changing environment.
• Effective communicator with excellent interpersonal skills and the ability to form productive working relationships at all levels across disciplines.
• Excellent attention to detail and working knowledge of FDA Regulations/Guidance's, Good Laboratory Practices, Good Manufacturing Practices, and ICH and USP/NF Guidelines.
• Self-motivated decision maker with a high degree of initiative, commitment and persistence to be successful.
• Sound knowledge of pharmaceutical regulatory requirements and good understanding of the Analytical development.
• Able to meet stringent timelines, quality demands and to initiate, develop and implement systems and strategies to ensure rapid and successful outcomes.
• Experience in building a team.
• Able to multitask.
• Extensive knowledge and hands on experience in analytical techniques.
• Technical writing.
• Excellent understanding of the theoretical background/fundamentals of Analytical Methodology.
• Understands regulatory and technical trends.
• Basic understanding of interviewing and employment practices.

EOE, including disability/vets.