Data Assistant
Resume:
Jacob R. Smith
Address as of July ****:
Apt. 6
Boston, MA 02134
Cell phone: 414-***-****
E-mail: *****.*****.*****@*****.***
Qualifications Summary:
• Over seven years of experience in a GMP pharmaceutical laboratory
• Experienced in analytical development, method development and validation
• Operational knowledge of HPLC (Agilent and Waters Alliance), GC (Agilent), and UV-
VIS (Thermo SpectraMax) and associated data processing
• Extensive knowledge of USP guidelines, especially relating to method validation
• Skilled in inhalation product testing, including dry powder inhalers (PDI), pressurized
metered dose inhalers (pMDI), Andersen Cascade and Next Generation Impaction
• Proficient with Empower Chromatography Data Software and MS Office
• Outstanding verbal and documentation skills
Work experience:
PPD, Inc.
Senior Scientist
2015 – Present
• Responsible for the development and validation of complex analytical methods for
numerous large pharmaceutical clients
Assay, content uniformity, impurities, degradation products by HPLC
o
Use of UV and PDA/DAD (3D data collection)
Determination of residual solvents, impurities by direct injection GC and
o
headspace GC
• Draft validation protocols, design testing methodology, complete and submit final reports
to QC/QA, address and respond to client comments and concerns
• Conduct Atypical and Out-of-Trend (OOT) / Out-of-Spec (OOS) investigations to
determine root cause and implement corrective and/or preventative action
• Routinely manage multiple projects and correspond with clients
• Mentor junior analysts in department on best practices
• Limited supervisor guidance
• Trained on ELISA
PPD, Inc.
Scientist
2012 – 2015
• Responsible for the development and validation of analytical methods for numerous large
pharmaceutical clients
Assay, content uniformity, impurities, degradation products by HPLC
o
• Perform remediation validations for marketed drug products
Assay, content uniformity, impurities, degradation products by HPLC
o
Protein impurities via UV-VIS
o
USP monograph testing
o
• Stability testing for marketed drug products
Determination of drug product components by HPLC
o
Use of UV, RI, and ESLD
Reversed and normal phase chromatography
Determination of free fatty acids
o
Use of silica columns, titrations
Osmolality determination
o
• Stability testing for early phase DNAi drug product
Determination of total oligonucleotide concentration by optical density at
o
260 nm
• Responsible for short-term heat and light degradation studies for marketed drug product
• Draft validation protocols, design testing methodology, complete and submit final reports
to QC/QA, address and respond to client comments and concerns
• Conduct Atypical and Out-of-Trend (OOT) / Out-of-Spec (OOS) investigations to
determine root cause and implement corrective and/or preventative action
PPD, Inc.
Associate Scientist
2009 – 2012
• Responsible for preparation, analysis, and data processing of delivered dose uniformity
(DDU) and aerodynamic particle size distribution (APSD) samples for a number of early
phase inhaled pharmaceutical drug products
• Processing and reporting of data from assay and impurities analysis of inhalation product
testing
• Six month on-site FTE for client laboratory in Waterford, Ireland
• Assist with client-contracted small-scale aseptic standard preparation
• Assist with small-scale formulation batches of pMDI samples
• Draft stability reports
PPD, Inc.
Assistant Scientist
2008 – 2009
• Responsible for preparation, analysis, and data processing of delivered dose uniformity
(DDU) and aerodynamic particle size distribution (APSD) samples for a number of early
phase inhaled pharmaceutical drug products
• Processing and reporting of data from HPLC assay analysis of inhalation product testing
Education:
University of Wisconsin
B.S. Biochemistry, Bacteriology (2007)
GPA: 3.0
References available upon request.
Contact this candidate