Manager, Research and Development (R&D) - Biotech Resume Search
Manager, Research and Development (R&D) - Biotech Resume Search
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Manager, Research and Development (R&D) Resume


Desired Industry: Biotech SpiderID: 81404
Desired Job Location: Willow Park, Texas Date Posted: 9/4/2018
Type of Position: Full-Time Permanent Availability Date:
Desired Wage: 75000
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: No
Highest Degree Attained: Masters Willing to Relocate: No


Objective:
Highly analytical, performance-focused, and results-driven professional with hands-on experience in analytical research and development; backed by strong background in quality control and quality assurance.
Equipped with solid ability in providing analytical chemistry services, implementing various methods and programs, as well as improving quality and production processes. Skilled in instrument installation and repair, product validation and release, materials handling, and regulatory compliance. Effective leader and concept-to-execution driver, with proven expertise in accomplishing various projects from inception to completion and delivery. Recognized for strategic management approach in directing and coordinating team efforts to achieve seamless and productive operations.


Experience:
AMRI (formerly Cedarburg Pharmaceuticals) | Germantown, WI
Analytical Scientist II: Aug 2007–Aug 2014
Served as a supplier and manufacturer quality auditor in China and the United States
Effectively utilized HPLC, GC, MS, and IC methodologies to handle all analytical development, validation, and support for various high-visibility projects
Performed administration of temporary employees daily activities in support of short-term toxin quantification projects
Proficiently dealt with all major HPLC, GC, and MS (LC and GC) training, repairs, and calibrations
Efficiently oversaw installation qualification (IQ's)/operational qualification (OQ's)/ performance qualification (PQ's) for all new analytical equipment
Expertly assessed and implemented companywide paperless server-based system for analytical data collection, processing, and storage using Chromeleon 7
Carried out isolation of impurities in support of their identification and structural elucidation as part of drug substance development projects through establishment of preparative HPLC conditions

Career Highlights:
Set a record high for audits accomplished in China and championed the instrument installations/repairs program, thus reducing the need to hire third-party auditors and instrument metrologists


Education:
University of Wisconsin–Milwaukee | Milwaukee, WI
Master of Business Administration: May 2012

University of Wisconsin–Milwaukee | Milwaukee, WI
Master of Science in Chemistry, Major in Inorganic Chemistry: Dec 2005

University of Wisconsin–Oshkosh | Oshkosh, WI
Bachelor of Science in Chemistry: May 2003


Additional Information:
Professional Development

Handling and Storage of Schedule II through V Controlled Substances

Technical Acumen

Minitab | Scifinder | Chemdraw | Microsoft Office Suite | ChemStation/OpenLab | Chromeleon 6 & 7 | Xcalibur
Empower 1 & 2

Presentations

Hergert, L. (2004). Functionalization, localization, and charge transfer of poly-metalated complexes. Spring 2004 Annual Awards Day, University of Wisconsin-Milwaukee, Milwaukee, WI.
Hergert, L. (2005a). Nitrogen activation through metal complexes. University of Wisconsin-Milwaukee, Milwaukee, WI.
Hergert, L. (2005b). Polyoxometalate (POM) derivatization. University of Wisconsin-Milwaukee, Milwaukee, WI.

Theses

Hergert, L. (2003). Polyhedral Oligomeric Silsesquioxane (POSS) synthesis and industrial uses. (Bachelor thesis). University of Wisconsin–Oshkosh, Oshkosh, WI.
Hergert, L. (2005). Studies on the Arylimido functionalization of Tetra-N-Butylammonium Hexamolybdate. (Master thesis). University of Wisconsin–Milwaukee, Milwaukee, WI.

Alcami Corporation (formerly Cambridge Major Laboratories) | Germantown, WI
Supervisor, Analytical Research and Development: Aug 2014–Jul 2018
Provided strategic leadership and training to the following teams and/or individuals:
A group of 5 analytical research and development (AR&D) scientists to support comprehensive drug substance development and validation projects under Food and Drug Administration (FDA), United States Pharmacopeia (USP), European Pharmacopoeia (EP), and International Conference on Harmonization (ICH) guidelines in a good manufacturing practices (GMP) environment, along with 12 indirect reports; and
Training Team to produce and implement analytical training materials and standard operating procedures (SOP's) for AR&D and Quality Control (QC) departments
Completed and proposed investigations, deviations, and corrective action preventive action (CAPA), in partnership with internal and external stakeholders
Actively assisted in creating, implementing, and improving analytical methods for release of raw materials, intermediates, final products, stability, and in-process testing, utilizing high-performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), and ion chromatography (IC) for early, late, and commercial phase projects
Defined project scope based on client request for quotation (RFQ) to prepare analytical activities for development, manufacturing, and release, in collaboration with site leadership
Conducted presentation of key performance indicators to site leadership on a biweekly basis, which involved lost time from poor quality or repeat work, resource utilization, and on-time delivery
Took charge of formulating and reviewing certificates of analysis (CoA), failure mode effects analysis (FMEA) reports, and batch records for GMP processes, as well as 185 test methods and 130 validation protocols/reports
Communicated effectively with vendors in relation to raw material method transfers, as well as method transfers between company facilities
Maintained active client interactions, from project implementation through closeout
Contributed to the hiring, onboarding, and training process of all new AR&D and QC employees

Career Highlights:
Led the execution of test method, validation protocol/report, and method transfer templates, which resulted in the reduction of turnaround time by threefold
Established reputation for being trustworthy as the only member of the AR&D Department to access the controlled substances safe
Boosted company efficiency by applying 5S in QC and AR&D laboratories and devising a Kanban system
Successfully trained and developed top performing team members, who were eventually chosen for the new AR&D Department
Created and pioneered "Alcami University" to success, Alcami’s official training program


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