Jacob R. Smith

Address as of July ****:

** ******** ***.

Apt. 6

Boston, MA 02134

Cell phone: 414-***-****

E-mail: acpq0i@r.postjobfree.com

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