Boguslawa Wilk Email & Phone Number

Bridgewater, New Jersey, United States

Basking Ridge, Nj

Princeton, Nj

Responsible for supporting and managing analytical development and QC at contract manufacturers.Preparing the drug substance and drug product section of regulatory filings.

Responsible for supporting and managing analytical development and QC at contract manufacturers.Preparing the drug substance section of regulatory filings.Directing analytical development of internal process chemistry.

Conceives plans, organizes and prioritizes work in support of pre-development and later stage projects ensuring timeliness of departmental schedules.Works with staff on development or improving organizational processes to better identify critical needs, meet timelines and streamline workflow.Helps staff in developing innovative analytical techniques, methods, and/or streamlining processes in support of business needs.Mentors staff in quality development.Chairs pre-development project representative program. Meets with pre-development project representatives to mentor and provide relevant tools necessary for proper project support. Provides review of analytical test schedules, technical review for API batch releases and Development Track documents.Responsible for the Reference Standard area and implementation of improvements to streamline processes.Performs critical reviews of Certificate of Analysis for Reference Standards and proof of structure reports for API, synthetic impurities, and degradants for IND submissions. Participates in technology transfer to outside suppliers and in internal technical transfer task force. Prepares documentation for regulatory filling.In conjunction with management, gives staff timely mid-year and year end performance reviews.

Conceives plans, organizes and prioritizes work in support of pre-development and later stage projects ensuring timeliness of departmental schedules.Works with staff on development or improving organizational processes to better identify critical needs, meet timelines and streamline workflow.Helps staff in developing innovative analytical techniques, methods, and/or streamlining processes in support of business needs.Mentors staff in quality development.Chairs pre-development project representative program. Meets with pre-development project representatives to mentor and provide relevant tools necessary for proper project support. Provides review of analytical test schedules, technical review for API batch releases and Development Track documents.Responsible for the Reference Standard area and implementation of improvements to streamline processes.Performs critical reviews of Certificate of Analysis for Reference Standards and proof of structure reports for API, synthetic impurities, and degradants for IND submissions. Participates in technology transfer to outside suppliers and in internal technical transfer task force. Prepares documentation for regulatory filling.In conjunction with management, gives staff timely mid-year and year end performance reviews.

Tracked and assigned projects within group and ensured quick, cGMP-compliant analytical support for releases of raw materials, synthetic intermediates, and cleaning verifications for Kilo Lab operations. Conceptualized and led team of 6-10 scientists in development and validation of analytical methods using modern techniques and experimental design.Managed multiple projects concurrently and ensured that specific objectives/goals were met. Presented project data at project team meetings, project review meetings, departmental meetings, and internal and external symposia, both domestic and international. Worked closely with direct reports to offer development opportunities. In conjunction with management, gave staff timely mid-year and year end performance reviews.Created, updated and maintained all applicable SOP's, reviewed deviations, change controls, OOS investigations. Prepared appropriate impact assessments and CAPAs in support of investigations.

Scheduled, assigned and prioritized work for staff ensuring that personnel were adequately trained for analyses. Provided quick turn-around analytical support for releases of APIs, raw materials, synthetic intermediates, and cleaning verifications (typically 2 days) for Pearl River Chemical Development Kilo Lab samples.Analytical team leader for multiple projects, responsible for analytical method development, validation and transfer, product characterization, and clinical supply release.Liaison between AR&D, Discovery, and Chemical Development: responsible for coordinating activities between different groups and sites.

Supported method development for raw materials, synthetic intermediates, APIs, and drug products.Independently designed and executed analytical method development (purity, assay, chiral purity) for intermediates, APIs, and final dosage form. Developed quick “in process” HPLC methods for reaction monitoring. Served as liaison between AR&D and analytical division of Discovery Research.Represented AR&D at weekly Chemical Development video conferences.

Supported HPLC method development for raw materials, synthetic intermediates, APIs, and final dosage forms.Conceived, planned, organized and performed work in support of pre-development projects ensuring timeliness of departmental schedules in collaboration with other groups.

Organized and taught organic chemistry courses.Conceived and organized organic and general chemistry laboratory sessions.Strengthened effective interpersonal, teaching, and supervisory skills.

Synthesized and characterized model compounds and intermediates for the mechanistic investigation of the rearrangements associated with coenzyme B12, permitting direct examination of competing theories proposed to govern the coenzyme B12 - dependent carbon skeleton rearrangements. Explored the synthetic routes towards the synthesis of different model series of cobalamins. Synthesized and isolated unstable intermediates of vitamin B12.Supervised undergraduate students for their major qualification projects.

Phd, Organic Physical Chemistry

Worked toward the synthesis and characterization of iodosocarboxylates - catalysts for the cleavage of phosphate and phosphonate.

M.Sc., Eng, Organic Chemistry And Technology