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Biotechnology Professional Profile
Scientific analyst with 9+ years in FDA-regulated cGMP environments analyzing and characterizing materials for pharmaceutical and medical device companies. Responsible for developing scale up processes for commercial peptide manufacturing, from small pilot lots to large validation campaigns. Best known for taking initiative to lead the analytical QC group in multitasking and streamlining to improve organizational efficiency
cGMP and SUPAC
PCR and sequencing
SDS-PAGE and IEF
UV-Vis, pH, osmolality
Freezing point osmometry
2011-2015 Specialist, Senior Quality Control Analyst
Planned and executed analytical testing of oligonucleotides and raw materials in support of product release for reagent manufacturing. Prior responsibility for testing and releasing nearly 400 oligonucleotides.
Research: Performed Real Time Stability (RTS) studies testing for various Analyte Specific Reagent (ASR) finished goods. Prepared interim and final RTS studies reports.
Validation: Partnered with Oligo Technical Services in method validation and engineering studies – creating an equivalence study to replace analytical RP-HPLC column; validation of newly acquired AB Sciex 5800 MALDI-TOF/TOF mass spectrophotometer
QA/QC: Cross-trained in functional testing for various finished goods product release testing. Played an instrumental role in completing product release and shipment in a dynamic environment by ensuring completeness and correctness of work products. Contributed to a first pass rate of >95% for final product release year after year.
Equipment OQ/PQ: Managed the maintenance of the QC laboratories by executing monthly cleanings, ensuring instruments and equipment were current on preventative maintenance and calibration, and restocked consumables of relevant equipment for continuity of operations.
Project Management: Independently balanced workload among Reagent Manufacturing and Quality Control analytical testing based on need and raw material release deadlines, due to compression of an 18-months product replenishment to 4-months.
Bachem California, Inc.
2007-2011 Chemist II Held key responsibilities in every aspect of peptide manufacturing. Led the manufacturing group to meet project milestones by working evenings and weekends.
High Performance: Exceeded expectations by becoming fully trained in Active Pharmaceutical Ingredient (API) production before the conventional two years employment timeframe.
Manufacturing: cGMP solid phase peptide synthesis, cleavage and isolation, multi-stage purification analysis high-resolution HPLC, lyophilization and final packaging
Product Development: Scale-up and Post-Approval Changes (SUPAC) – converted projects from Research and Development scale to commercial scale; implemented process development and resource optimization at each phase in the manufacturing process of up to kilograms scale of the final API; completed manufacturing process and equipment validation that led to the commercialization of Hematide API
Functional Management: Supervised laboratory technicians in all stages of API production resulting in meeting the goal for excellence with compliance in cGMP, safety, and hazardous chemicals management
Siemens Medical Solutions Diagnostics
2006-2007 Research Associate
Helped Critical Reagents group in assessing the quality of antibodies and antigens for use further use in immunodiagnostic test kits by implementing biochemical techniques ranging from protein-A purification to sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) and Isoelectric Focusing (IEF)
Laboratory Management: Undertook senior responsibilities to train new personnel, preparing new chromatography columns, monitoring column inventory and utilization, etc.
Critical Thinking: Assisted scientists in troubleshooting the separation of problematic impurity that arose during the cell growth of a particular antigen
Loyola Marymount University
2005-2006 Undergraduate Research Assistant
Molecular Biology: Facilitated the research focus of the principal investigator in characterizing RNA-binding functions and involvement in neuromuscular disease and examining ribosome biogenesis, mRNA localization, and mcyobacteriophage.
Bachelor of Science: Biology / Minor: Biochemistry
Additional Skills and Qualifications
Quality Systems: QSR: ISO 9001: 2008 ISO 13485: 2003 (Medical Device) / ICH Q7 (API Manufacturing)
Quality Documentation: Batch record review, Out of Tolerance (OOT) investigations, document revisions in Electronic Document Management Systems (EDMS), Change Control and Customer Complaint investigations, generated Out of Specification (OOS) reports, supported Corrective and Preventative Action (CAPA) investigations
Jerrald R. Lamarca
Mobile: (310) 903-0937 | Email: firstname.lastname@example.org | San Francisco Bay Area, CAsearch: Performed Real Time Stability (RTS) studies testing for various Analyte Specific Reagent (ASR) finished goods. Prepared interim and final RTS studies reports.