Melissa Kiser Email & Phone Number

Lawrence Township, Nj, Us

• Act as the primary Quality representative supporting Alliance partnership(s) by providing timely updates to internal and joint teams on manufacturing, testing, and shipping of vector supply from partner CMOs. • Provides support to the Supplier QA teams providing oversight of ongoing manufacturing processes for vector/plasmid. • Responsible for Quality oversight, and partnership with internal support functions (Supply Chain, MS&T, etc.), for vector supply to alliance partners.• Develops supplier qualification practices that use risk-based tools for assessments, qualification and performance monitoring that consider KPI development/tracking and operational deliverables. • Develops and implements policies and procedures for CMO compliance, including development of Quality Agreements, Quality Business Processes, Product Disposition and Deviations, Corrective Actions. • Ensures approved quality systems are established and maintained to BMS quality standards and regulatory requirements. • Participates with BMS’s External Manufacturing team and the Virtual Plant Team to ensure consistent and collaborative messaging to external manufacturing partners. • Works cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners.• Effectively communicates issues, risks and proposed solutions within the organization. • Serves as subject matter expert (SME) for change controls, deviations, and CAPAs impacting alliance partners. • Assists with and provides QA approval of deviations, OOS, investigations, CAPAs, changes, validation documentation, and other related GMP documentation, as required. • Provides communication, support, and guidance to manufacturing partners and within the QA CMO team. • Supports internal and external audits as needed, including PLI/PAI preparations. Supports Inspection Readiness Activities at CMOs Supports KPI, metrics and other CMO Improvement Initiatives.

Bothell, Wa, Us

Lead all aspects of a Quality Control department, hiring and developing staff, providing strategic decision making consistent with department and organizational goals, and ensuring cGMP compliance throughout Quality Control laboratories and operations.• Lead and manage activities of quality control personnel and ensure the efficiency and effectiveness of activities related to in-process, drug product lot release testing, stability testing, analytical method transfer and analytical method validation.• Assist in the design, implementation and continuous improvement of Quality Control systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.• Oversee laboratory investigations, deviations, CAPAs, and troubleshooting.• Act as a subject matter expert for QC GMP operations during audits and regulatory inspections.• Lead the progression of QC projects from the proposal stage through project completion by interacting with the client, technical teams, and business development team.• Cultivate effective communication, cooperation and trust with clients and internal stakeholders.• Work closely with team members across all related business units and with the management team to ensure coordination of all efforts and real-time communication with all stakeholders.

Bothell, Wa, Us

Ensure cross-functional coordination and collaboration between external customers, internal departments, and across multiple sites for contracted manufacturing programs. Responsible for technical and scientific oversight of contracted Quality Control activities for analytical method validation and routine GMP testing. Responsibilities include client communication, protocol and report writing, data review, result quality, investigations, and Certificate of Analysis preparation.• Communicate and collaborate cross-functionally with external customers and internal subject matter experts to ensure contracted manufacturing programs are supported by Quality Control. • Quality Control subject matter expert during client and regulatory inspections• Write/review quality system documents including protocols, reports, analytical methods, manufacturing batch records, quality standards, and SOPs.• Collaborate during laboratory investigations, deviations, and CAPAs. Present data to internal and external stakeholders.

Louisville, Colorado, Us

Provide technical and scientific oversight of high complexity clinical diagnostic testing. Responsible for staff hiring, management, scheduling, training, competency assessment, and direct observation. Ensure proper functioning of laboratory equipment, including troubleshooting, preventive and corrective maintenance, and calibration. Maintain supplier relationships.• Monitor production operations for quality and compliance with regulatory standards.• Managed implementation of new technological improvements resulting in 75% reduction in turn around time and 50% reduction in laboratory cost.• Guide, coach and lead laboratory team of 7 staff, delegating tasks and evaluating performance and progression of projects.• Ensure staff compliance with relevant regulations and laboratory safety policies. Serve as laboratory safety office / chemical hygiene officer.

Louisville, Colorado, Us

Supervised and supported testing personnel responsible for executing laboratory protocols and generating clinical results. Worked with complex methodology (protein/peptide separation) and laboratory equipment (HPLC, LC-MS/MS) in a strict regulated environment (CLIA, CAP). Demonstrated good laboratory practice, trouble-shooting and problem solving capability, attention to detail, organization, and good documentation practice. • Trained and supervised testing personnel in high complexity testing within the specialty of chemistry.• Provided leadership, expertise, and direction to staff in troubleshooting and solving analytical challenges.• Oversight of all laboratory operations including establishment of quality metrics, scheduling, inventory management, equipment qualification, calibration and maintenance, contamination control, and safety.• Complied with CLIA and CAP regulations and guidelines including New York State CLEP. • Conducted direct observations and evaluated competency of testing personnel.• Wrote/reviewed quality system documents.• Qualified as testing personnel in protein depletion, tryptic digestion, solid phase extraction, peptide LC-MS/MS analysis, laboratory result review and approval.• Documented investigations and implemented corrective actions prior to approving patient test results.

Supervised and supported testing personnel responsible for executing laboratory protocols and generating clinical results. Worked with complex methodology (protein/peptide separation) and laboratory equipment (HPLC, LC-MS/MS) in a strict regulated environment (CLIA, CAP). Demonstrated good laboratory practice, trouble-shooting and problem solving capability, attention to detail, organization, and good documentation practice. • Trained and supervised testing personnel in high complexity testing within the specialty of chemistry.• Provided leadership, expertise, and direction to staff in troubleshooting and solving analytical challenges.• Oversight of all laboratory operations including establishment of quality metrics, scheduling, inventory management, equipment qualification, calibration and maintenance, contamination control, and safety.• Complied with CLIA and CAP regulations and guidelines including New York State CLEP. • Conducted direct observations and evaluated competency of testing personnel.• Wrote/reviewed quality system documents.• Qualified as testing personnel in protein depletion, tryptic digestion, solid phase extraction, peptide LC-MS/MS analysis, laboratory result review and approval.• Documented investigations and implemented corrective actions prior to approving patient test results.

Responsible for overall project management of multiple bioanalytical studies for the pharmaceutical industry. Responsibilities included client communication, proposal writing, scheduling analysts work and instrument time, data review and interpretation, quality of results, report preparation, and invoicing. Responsible for the analysis of up to 8,000 samples per month for multiple innovator and generic companies. • Directed projects utilizing LC-MS/MS methods for the analysis of pharmaceuticals and their metabolites in biological matrices, for new drugs and generic applications.• Provided leadership, expertise, and direction to staff in troubleshooting and solving analytical challenges.• Complied with strict FDA and EMA (European Medicines Agency) regulations and guidelines. • Ensured validation work was performed on legacy methods to meet current regulatory standards.• Wrote/reviewed protocols, quality system documents, analytical procedures, and sample analysis reports.• Provided clients with weekly progress reports.• Served as principal investigator to support non-clinical and clinical studies including bioequivalence (BE) and bioavaliability (BA) studies. Ensured first-to-file studies were completed within expedited timelines.• Worked with pharmacokineticists to provide data interpretation.• Clients ranged from major international drug companies to university researchers in fields such as pain management, schizophrenia, inflammation, and cancer. • Met with client auditors to explain documentation, analytical procedures, results, and answer questions regarding studies, laboratory practices, and procedures.

West Lafayette, In, Us

Responsible for all aspects of contracted work. Typically assigned 10-20 projects for multiple clients running simultaneously requiring daily client contact. Had reputation for exceeding customer expectations by delivering ahead of schedule and within budget while maintaining high quality standards. Managed approximately 150 projects (ranging in length up to five years) for an estimated thirty U.S. and European clients ranging from entrepreneurial start-ups to major drug companies.• Directed the development, validation, and application of bioanalytical LC-MS/MS methods for the analysis of drugs in biological matrices. Worked with known infectious (e.g. HIV, hepatitis) and biohazardous materials following laboratory safety practices and procedures. Followed FDA and EMA regulations and guidelines.• Samples included blood, plasma, urine, and tissue (artery, brain, kidney, liver, lung, muscle, myocardial, and spleen) from species such as mouse, rat, rabbit, cat, dog, monkey, sheep, pig, and human.• Met with client auditors and FDA inspectors to explain documentation, analytical procedures, results, and answer questions regarding studies, laboratory practices, and procedures. • Prepared and presented posters at professional meetings. Represented company at conferences.• Provided supervision, leadership, training, mentoring, and employee performance evaluations to laboratory analysts and technicians (2-4 staff).

West Lafayette, In, Us

Coordinated and performed all aspects of contracted studies including client communication, LC-MS/MS method development, troubleshooting, validation, and analysis of drugs in biological matrices per FDA regulations and guidelines. Served as principal investigator for internal projects including preparation of protocols and final reports. Supervised laboratory analysts and technicians (1-2 staff).

West Lafayette, In, Us

Performed bioanalytical method development, validation, and analysis using LC-MS/MS per FDA regulations and guidelines, with minimal supervision.

Performed HPLC method development and validation per cGMP regulations.