Assistant Manager
Resume:
Barbara L. Renze
Stewartstown, PA 17363
http://www.linkedin.com/in/barbararenze
PROFILE
Experienced analytical chemist with more than 25 years of consistently strong results in the Pharmaceutical and Agricultural Products Industries. A hands-on leader, adept at developing and validating analytical methods and protocols in accordance with GMP/GLP guidelines with specific expertise in gas and liquid chromatography. Skilled in preparation of CMC documents for regulatory submissions and responses to inquiries. Strong organizational skills and multitasking capabilities as demonstrated by the success of multiple pharmaceutical development projects.
PROFESSIONAL EXPERIENCE
PHARMACEUTICS INTERNATIONAL INCORPORATED (PII), Hunt Valley, MD
A $100 M privately owned, Pharmaceutical CDMO
Associate Director (2015-2019), Regulatory Compliance, Technical Documentation Group
Section Head (2012-2015)
Group Leader (2010-2012)
Responsibilities included overseeing the Technical Documentation Group (12 individuals), which was comprised of the Technical Writing Group, the Technical Auditing Group, and the CMC Documentation Group. The groups prepared, edited and audited analytical test methods, validation protocols and validation reports. The CMC Documentation Group provided documentation (such as Stability summary reports, Impurity tables, Residual Solvents Compliance Reports, Elemental Impurity Reports, COAs (Certificates of Analysis), Test Methods, Specifications, Justifications of Specifications, Validation Protocols and Reports, Stability Protocols and Post-Approval Stability Protocols) to the Regulatory Affairs Team to be included in CMC sections in ANDA and NDA Regulatory submissions. The group also provided documentation in response to deficiency inquiries from the FDA and other Regulatory agencies.
PFIZER, INC. (FORMERLY WYETH, INC.), Princeton, NJ
A $210 B Global Pharmaceutical Company
Sr. Scientist III (2008-2010), Analytical Services
Sr. Scientist II (2004-2008)
Analyzed formulated pharmaceutical products and APIs by HPLC and other techniques. Independently planned, executed, and interpreted work on complex analytical projects including stability studies. Wrote work plans including method validation, site qualification, and vendor qualification; wrote/revised SOPs (Standard Operating Procedures) and JHAs (Job Hazard Analyses) for the Analytical Group. Reviewed/revised test methods and specifications for APIs and drug products under development. Maintained familiarity with appropriate compendial methods, monographs, and GMP guidelines that supported product development. Provided supervision and oversight to junior scientists.
Project Leader for the analytical research and development of two veterinary pharmaceutical products, one of which was ultimately registered with the MHRA.
Developed new HPLC methods of analysis that determined active ingredients and minor components for products in development; performed method validations and wrote summary reports.
Prepared COAs for raw materials and finished drug products in support of clinical trials.
Performed analytical methods transfer to Wyeth (Fort Dodge) Manufacturing Plants and CROs, and assisted in site qualification/validation.
Provided written responses to regulatory agencies (FDA, EU) during product submission review processes.
Represented the Analytical and Process Group representative on a site-wide Health and Safety Committee and served as the back-up safety meeting coordinator for the Analytical Group.
FMC CORPORATION, Plainsboro, NJ
A $4B Specialty Chemical company specializing in Agricultural Products
Sr. Associate Research Chemist (2001-2004)
Associate Research Chemist (1997-2001)
Sr. Chemist (1994-1997), Analytical Department, Agricultural Products Group
Analyzed formulated and technical pesticide samples for release and stability studies. Provided chromatographic support for product chemistry studies and new process development programs; performed analyses resulting in the certification of product ingredients. Analyzed water and soil samples, as well as industrial hygiene samples for trace amounts of pesticides.
Led a collaborative effort to solve a complex chromatographic problem in which an impurity was co-eluting with a peak of interest, previously unknown to my company and a partnering company. Received a “Technical Achievement Award” for this work.
Developed and validated HPLC and GC methods in support of two agricultural products which were ultimately registered with global regulatory agencies. Received a “Technical Achievement Award” for this work.
Maintained Study Director responsibilities for analytical GLP studies; wrote and issued study protocols and final reports.
Provided oversight for the Industrial Hygiene program at the Research and Development Center to protect health and safety of workers and comply with OSHA regulations.
Lead a division-wide Safety Team that designed and implemented behavior-based safety programs for various departments to reduce workplace incidents. The team also participated in safety training, audits and the OSHA VPP program.
Miami University, Oxford, OH 1991 - 1994
Graduate Assistant, Research Assistant (1991-1994)
Research for Master's thesis involved the development of novel methods of separation and pre-concentration of metal ions using membrane transport and liquid-liquid partitioning techniques, coupled with analysis by flame and furnace AA. Supervised laboratory experiments performed by undergraduate students. Initiated research on an industry-supported project aimed at the development of new methods of background suppression for Ion Chromatography.
EDUCATION
Masters in Chemistry – Name your thesis here
Miami University, Oxford OH
Bachelors of Science in Chemistry
Saint Vincent College, Latrobe, PA
TECHNICAL SKILLS
•Technical Writing (Validation Protocols, Reports; SOPs; Test Methods; Specifications)
•Liquid Chromatography (HPLC)
•Gas Chromatography (GC)
•HPLC-MS
•GC-MS
•Solid Phase Extraction (SPE)
•Ultraviolet Spectroscopy (UV-Vis)
•Infrared Spectroscopy (FT-IR)
•Thin Layer Chromatography (TLC)
•Karl Fischer Water – Volumetric
•Viscosity
•Density
•Dissolution
•HP/Agilent Chemstation Software
•Perkin-Elmer Total Chrom Software
Contact this candidate