Mary Bower Email & Phone Number

West Lafayette, In, Us

West Lafayette, Indiana, United States

West Lafayette, Indiana

Responsible to provide support to Method Development, Pre-Formulation, and Analytical Technologies groups in a variety of large and small molecule characterization techniques inclusive of liquid chromatography (HPLC and UPLC), high-resolution mass spectrometry (HRMS), peptide mapping, and amino acid analysis (AAA) in a cGMP contract research organization. Independent project leader for > 40 client-based projects enabling SSCI to gain industry traction as a recognized quality analytical service provider.• Effectively executed method transfer, development, and validation activities resulting in numerous client-specific methods effectively securing future projects for organization. • Consistently provided highly detailed composition and review of instrument operating procedures that ultimately were designated as secure documents for use by 25 peer Scientists.• Project leader for a time and data-dependent purity analysis in drug substance and drug product project resulting in ~$1.3M/year revenue for 2 consecutive years.• Chosen in a peer-selection for a Change Council group to implement policy improvements with the goal of improved employee satisfaction and safety. Generated detailed training document for newly appointed project leaders, implemented a streamlined chemical and laboratory inventory system, and improved Spot Award nomination and approval procedures. Utilized Lean Six Sigma principals to accomplish goals.

West Lafayette, Indiana

Performed hands-on cGMP analysis for clients involving techniques including LC-MS/MS (Triple Quad Ion Trap ESI, MALDI-TOF), N-terminal protein sequence analysis (Edman), HPLC (analytical and ultra), polyacrylamide gel electrophoresis (PAGE), and amino acid analysis (AAA). Provided support in multiple areas of operations in support of 65+ scientists• Managed a time sensitive cGMP method transfer and method generation for LC-MS impurity assay resulting in over 2 years of continuous project requests and ~ $900K of revenue. • Mentored peer scientists in support of structural analysis of client API and associated impurities by LC & LC-MS. Project success led to validation activities and method generation securing new business & additional revenue.• Led multiple calibration and maintenance projects on all (11) HPLC systems on site.• Conducted and documented instrument investigations in response to failed calibration or erroneous events. Determined root cause of failures, created preventative measures, and integrated solutions into IOP’s. • Point person for LIMS and instrumentation training of >15 newly hired Scientists in response to growth of Method Development and Analytics team. • Supervised Sr. Research Specialist responsible for essential site-wide support duties; inventory management, microbalance calibration, glassware cleaning/maintenance, and monitoring of temperature controlled devices.

West Lafayette, In

Responsible for installation and qualification of systems acquired for introduction of biochemistry group at SSCI. Systems included Acquity UPLC system, N-terminal protein sequencer, MALDI- TOF, micro-plate reader, and polyacrylamide gel electrophoresis system. Generated brand new instrument operating procedures (IOP’s) for each system bringing all systems into cGMP compliance enabling the offerings of new biotechnology services.• Carried out client-specific method development and transfer of amino acid analysis techniques including analysis of non-standard amino acids using non-conventional methods.• Compiled method transfer and validation protocol for protein sequence analysis, conducted testing and generated corresponding method ensuring future client sample analysis requests.• Executed mapping procedures per established protocols on new temperature control devices unique to biochemistry group to provide proper USP sample storage conditions.

West Lafayette, In

Provided various analytical services to university Researchers. Actively maintained, diagnosed malfunctions, and repaired instrumentation as needed including pump seal replacement, plumbing repair and valve block replacement. • Facilitated a laboratory expansion/transition into more focus on proteomics-based services by acquiring hands-on experience in iso-electric focusing, 2-dimensional gel electrophoresis.• Proficient with MALDI TOF-TOF and subsequent database search analysis on protein mass fingerprint data.• Key member of project team to expand laboratory’s service offerings with the addition of new capabilities including 2 olionucleotide synthesizers, peptide synthesizer and 1 fully upgraded N-terminal protein sequencer.