Shena Peter Email & Phone Number

Northfield, Il, Us

Northfield, Il, Us

Bad Homburg, Hessen, De

Supervise 3 employees and provide guidance to a process validation team of 12. Developed a departmental performance and training metric. Continuously utilizing behavioral tools and techniques to develop a team of high performers who achieve results.Responsible for the oversight of 50+ projects per year. Developed a project database for 100+ Technology Transfer projects that utilizes pivot tables to improve awareness of project timelines and resource constraints.Collaborate with 15+ departments to ensure that assigned action items are completed within critical timelines for drug submissions and new product launches:Engineering, Validation, Operations, Product Development (I&D), Technical Services, Quality Control (Microbiology and Chemistry), Stability, Purchasing, Materials, Quality Assurance (Laboratory & Product Validation, Documentation, Manufacturing, and Batch Release), FDA Regulatory, Regulatory Affairs, Global Medical Affairs, and Training & DevelopmentSME for internal and external audits and maintain the cross-contamination quality system.SME for improving cleaning validation program. Audit reports in 2018 acknowledged the cleaning validation program as one of the top programs well developed within the organization.

Bad Homburg, Hessen, De

Lead a regional harmonization team for three USA manufacturing facilities. Streamlined and developed systems, programs, training, and documents by utilizing Lean Six Sigma principles to improve process efficiencies and reduce wastes.Closed a cleaning validation gap for the waiver of 40+ grandfathered products by providing thorough assessment in a FMEA risk assessment. Reduced lead time on calculating residual cross contamination chemical limits by generating a database of all critical manufacturing equipment.Responsible for the interpretation of scientific data, deviation investigations, and final reports and implement improvements where needed.

Bad Homburg, Hessen, De

Core team member for new product launches (liaison between Project Manager and the Plant).Validated the manufacturing process for a new product launch. Collaborated with Regulatory and Compliance, Manufacturing Quality Assurance, and Packaging to implement a visual inspection process on the packaging line to prevent discolored vials from reaching the field.Developed and validated a cleaning procedure for the largest formulation tank at the facility that utilized CIP technology; start of commercial manufacture of the largest volume products (over 1M units per batch) was dependent on completion of this project.

Dekalb, Il, Us

Developed a catalyst free methodology for the formation of hexagonal boron nitride nanosheet; received USA patent US10236122B2. Presented nanomaterial research at the BORAM XIII international conference. Companies appearing at this conference included Sony and Toyota. Nobel Laureates in Chemistry appearing and being awarded at this conference include Ei ichi Negishi of Purdue University and Akira Suzuki of Hokkaido University. Supervised undergraduate students in a research laboratory for development of drug delivery molecules for Boron Nutron Capture therapy, a cancer treatment. Synthesized and characterize boron nitride, graphene, heterostructures, and magnesium nanomaterials for material science applications.

Dekalb, Il, Us

Maintain OSHA safety standards for laboratory courses. Laboratory TA for General Chemistry and Inorganic Chemistry.Developed a rubric for Inorganic Chemistry reports so students understood how they were being measured; resulted in students becoming more engaged with the learnign process.Conducted General and Inorganic Chemistry review sessions to better prepare students for exams.

Master'S Degree, Chemistry

Bachelor Of Science (B.S.), Chemistry And Biology