PROFESSIONAL EXPERIENCE:

Confidential

Program manager

Responsibilities:

• Managed program and technical requirements of the client assets
• Managed client Request for Information and Request for Proposals
• Managed all aspects of the client’s assets from clinical to commercial release
• Monitored the studies internally and externally to improve efficiencies
• Used MicroSoft Project to map out the program’s lifecycle to predict and avoid bottlenecks to program completion.
• Led weekly meetings to present updates using Power Point, Excel with Pivot Tables to summarize programs progress (conducted with internal groups and external clients)

Confidential

Supported Operations and QA

Responsibilities:

• Capable of leading high performing teams under tough deadlines, to meet expectations of multiple customers.
• Strong communicator skills (verbal and written).
• Problem solver - Creativity and forethought in solving complex project issues.
• Organizational ability and multi-tasking skills.
• Service orientation - “People person” and a team player.

Confidential

Manager

Responsibilities:

• Quality and Compliance leader for the Confidential Onsite Staffing Program.
• Designed Quality Department goals and objectives for individual and organizational development needs.
• Controlled and monitored all quality systems through monthly metrics and management review meetings.
• Interfaced with Operations, Quality Management and Product Development to assure processes were maintained in a state in accordance with cGMP regulations and company standards and systems.
• Designed and developed Monthly Management Review System for the Confidential Onsite Staffing Program.
• Presenting Quality Metrics and Key Performance Indicator Results
• Performing Quarterly assessment of Metrics and Key Performance Indicators to ensure objectives are being met.
• Directly manage and supervise 60 laboratory chemists, technicians, auditors and administrative assistants.
• Inhalation Group- seven employees
• Extractable/Leachable Studies guided by PQRI 1, OINDP 2, IPAC-RS 3, 21CFR part 211.94(a).
• Device development and testing guided by 21 CFR part 200 general, ICH and CDER.
• Biopharmaceutical Group- nine employees
• Method development and stability studies in large molecule
• BLA preparation following 21 CFR part 601.
• Bioanalytical Group- nine employees
• Method development working with biological sample matrices.
• Raw Materials Group- six employees
• Developed an in house testing group for all raw materials used for manufacturing of the API and Drug Product.
• Method development using USP-NF, BP, EP and JP for starting points.
• Perform raw material testing of all materials from outside vendors as per USP-NF and in house methods.
• Review and release raw materials for manufacturing use.
• Small Molecule Group- 22 employees
• Support manufacturing by performing in process testing of batches prior to approving for release.
• Assist in formulation department by developing methods for analysis.
• Responsible for department staffing and budgeting costs.
• Established new and enhanced existing Confidential policies and procedures.
• Reduced cost from 3K/headcount to less than $250/headcount.
• Set up group at each client site to support client site groups.
• Collaborated with the IT group to establish a global Point of Contact for the onsite employees.
• Ensured employees maintained compliance with cGMP regulations and Confidential policies and procedures.
• Developed a monthly record review system for the Confidential Onsite Staffing
• Reduced late notifications from 22/month to 5.
• In less than two years group revenue grew from $1.2m to over $12m annually and grew the Confidential Onsite FTE teams from one client site to six client sites.

Confidential

Group Leader/Senior Group Leader

Responsibilities:

• Quality and Compliance leader for the Biopharmaceutical Group.
• Established new and enhanced existing Confidential policies and procedures.
• Worked with Quality Assurance to developed quality assurance program.
• Ensured laboratory maintained compliance with cGMP regulations and Confidential policies and procedures.
• Reviewed Pharmaceutical Technology White Papers to stay current in industry processes.
• Kept current of quality alerts be reviewing “The Gold Sheet” an independent monthly report providing in-depth analysis of the latest quality control and compliance issues.
• Personally responsible for performing laboratory audits.
• Designed and developed an internal mock inspection program to ensure lab was in an FDA ready state.
• Issued reports on Quality Compliance Issues observed.
• Performed follow up action plans for significant occurrences.
• Designed Quality Department goals and objectives for individual and organizational development needs.
• Directly managed and supervised over five+ employees and eight clients.
• Group revenue average was $20K/headcount.
• Group averaged three validations/month.
• Developed ELISA, Residual DNA and SEC methods for protein samples upstream and downstream of the purification process.
• Developed kinetic activity methods monitoring peroxidase activity.
• Developed and ion chromatography method (SME) for the detection of sulfate in heparin.
• Evaluated extractable/leachable in packaging and labeling of IV bags (PQRI).
• Interfaced with Operations, Quality Management and Product Development to assure processes were maintained in accordance with cGMP regulations and company standards and systems.
• In conjunction with the Confidential Quality Assurance Department designed and developed Quality and Compliance systems, procedures and policies.
• Collaborated with Quality Assurance and Sample Management for a Cold Chain Custody of samples.
• Established Document Control System for client specific batch records in ECM.
• Established Deviation and Corrective and Preventative Action System in ECM.
• Train group on Root Cause Analysis on Out of Specification or Out of Trend results.
• Reviewed and approved all Deviations and Corrective and Preventative Actions.
• Established Client Quality Complaint Committee.
• Each complaint was investigated using a Root Cause Analysis approach.
• Established a preventative action plan to prevent repeat occurrences.
• Developed a client questionnaire to determine effectiveness of implementation of program.
• Approved and authorized specifications, sample instructions and test methods for all raw material, finished product and stability samples.
• Supervised all physical, chemical and microbiological analyses on raw materials, finished products and stability samples.
• Collaborated with the microbiology group to develop a method to determine dye content in uricase by UV.
• Authored and supervised the validation of the method for dye content.
• Reviewed and approved all method validation protocols and reports.
• Reviewed and approved all Out-Of-Specification and Out-Of-Trend investigation reports.
• Approved or rejected results from raw materials, in-process materials and finished products based on raw data and laboratory analysis reports.
• Worked directly with the client on BLA submittal.
• Collaborated with client upon the receipt of a denial for their application.
• Reviewed FDA comments with the client and recommended where additional testing and method evaluations were needed.
• Gathered and reviewed all raw data from three years of stability studies for multiple lots of drug substance and drug product set down in multiple stress conditions.
• Modified the report format to fit into BLA requirements.
• Participated in FDA review of targeted data submitted to support the BLA.

Confidential

Senior Scientist Method Development/Validation in Analytical Support

Responsibilities:

• Responsible for developing and validating methods for client raw materials, in process and final products to support Phase II and Phase III studies.
• Authored validation protocols as per ICH-Guidance for Industry Q2A and Q2B.
• Small Molecule Methodology
• Developed RP-HPLC methods to detect process impurities within sample matrices.
• Developed GC-FID headspace method to determine trace levels of various volatile organics.
• Validated methods to determine the process impurities in the client’s tracer compound.
• Developed and validated an anion chromatography method using ion chromatography to detect trace impurities in drug products.
• Inhalation Methodology
• Developed a method to determine trace levels of benzaldehyde and benzyl alcohol in nasal spray.
• Developed an Anderson Cascade Impactor method by using a non-volatile diluent to diminish volatile vapors.
• Authored validation protocols, methods and equipment qualification protocols.
• Authored SOPs.

Confidential

Scientist/Senior Scientist Inhalation Department

Responsibilities:

• Responsible for developing and setting up the inhalation lab to perform method development, validation and stability studies.
• Quality and Compliance for the Inhalation Group.
• Established new and enhanced existing Confidential policies and procedures.
• Worked with Quality Assurance to developed quality assurance program.
• Ensured laboratory maintained compliance with cGMP regulations and Confidential policies and procedures.
• Worked with Quality Assurance to develop SOPs and standardized laboratory notebook review.
• Subject Matter Expert (SME) for Impurities Analysis in inhaled devices.
• Improved method efficiency from an 85% system suitability failure to a 5% failure.
• Stability sample analysis testing deviations was decreased from 10 deviations per stability pull to 0 deviations in six weeks.
• System investigations decreased from three per week to zero.
• Stability data turn around time decreased from 85 days to seven days.
• Final report issued to client decreased from 120 days to 13 days.
• Client satisfaction increased from a low to excellent which resulted in an increase in studies launched.

Confidential

Scientist Small Molecule Product Analysis Department

Responsibilities:

• Responsible for seven product lines for one client.
• Launched multiple lots of drug product for stability studies as per ICH guidance.
• Authored stability protocols.
• Determined amount of sample required for stability launch.
• Collaborated across groups to schedule stability testing in physicals and micro.
• Reviewed all data for quality and compliance to study protocols and test methods.
• Worked with Quality Assurance to finalize data review.
• Performed data trend analysis and investigated any out of specification or alert limit values.
• Responsible for communicating with the client the status of the stability studies and issue of final stability report.

Confidential

Group Leader of Semi-Volatiles

Responsibilities:

• Responsible for supervising a group of four employees performing GC analysis of trace level contaminants in air, water, soil, waste and biota. Involved with testing for Aquatic Toxicity, Dioxin/Furans, Explosives/Perchlorates, Low Level Mercury, PCB Congeners, Perfluorochemicals, Soil Vapor Intrusion, NSF Water Supply and Treatment Products, Responsible for communicating with the client results that were above the action limits.

Confidential

Custom Industrial Analysis Scientist

Responsibilities:

• Performed wet chemistry testing per the USP-NF, EP, BP, JP and client supplied methods.
• Testing performed; spectrometric analysis using HPLC, UV, and IR, head space analysis by GC-FID, wet chemistry techniques (Mohr Titration), Karl Fisher, Kjeldahl (total nitrogen determination).

Confidential - St. Joseph, MO

Chemical Analyst

Responsibilities:

• Served as Quality Control analyst for the production of animal pharmaceuticals.
• Performed HPLC assay analysis, KF, Arsenic and titrations.