Summary
Overview
Work History
Education
Skills
Certification
Timeline
Accomplishments
Generic

Andrew Hershberger

Durham,NC

Summary

Highly motivated team player who brings nearly a decade of experience working for CDMO's in the biomanufacturing space. Expertise in formulation, filling, component prep, sterilization, purification, cell culture and much more. A skilled person who loves helping companies and people improve the lives of patients. Thrive in complex and technical work. Great attention to detail. A leader, responsible, hardworking, honest, reliable and results driven. Able to learn fast. Looking to work together with a great team in order to improve the lives of patients, achieve results and advance career.

Overview

9
9
years of professional experience
1
1
Certificate

Work History

Sr. Manufacturing Associate (Purification)

KBI
Durham, NC
07.2022 - Current
  • Collaborated with team members to meet production deadlines.
  • Production of bulk drug product.
  • Operation of chromatography skids, mixers, filtrations, pumps, scales, spectrophotometers and other lab equipment.
  • Increased team productivity by providing ongoing training, guidance, and support to fellow associates.
  • Collaborated effectively with cross-functional teams to troubleshoot issues, optimize processes, and achieve common goals.
  • Streamlined workflow with efficient organization of workstations, ensuring necessary tools were always readily available.
  • Minimized equipment downtime by performing routine maintenance tasks and timely reporting any malfunctions to supervisors.
  • Supported implementation of new procedures or systems within facility, adapting quickly.
  • Improved production efficiency by streamlining assembly processes and implementing lean manufacturing techniques.

Team Lead - Bulk Drug Substance Purification Downstream

Catalent Pharma Solutions
Bloomington, IN
10.2017 - 08.2021
  • Floor supervision totaling 8 employees in 3 downstream rooms.
  • Led shift exchange meetings.
  • Updated management on manufacturing status, successes, needs, goals, problems and timelines.
  • Relayed issues or concerns with supporting departments in order to keep production running.
  • Worked with Manufacturing Sciences to improve batch records and processes.
  • Standard operating procedure author, reviewer and approver.
  • Worked at or supervised different stations to provide optimal coverage and meet production goals.
  • Evaluated employee skills and knowledge regularly, training and mentoring individuals when required.
  • Assisted with process deviation reports.
  • Worked on validating or qualifying new equipment and engineering test protocols.
  • Helped with process troubleshooting.
  • Led manufacturing studies and improvement projects.
  • Continuously checked products for quality assurance.
  • Took on additional job duties during unexpected backlog, resulting in meeting project target date.

Manufacturing Associate Purification / Formulation

Cook Pharmica / Catalent Pharma Solutions
Bloomington, IN
09.2014 - 10.2017
  • Teamwork to ensure that products were produced on time and maintained safety, identity, strength, purity and quality.
  • Proved successful working within tight deadlines and fast-paced atmosphere.
  • Harvested drug substance material from Upstream using depth filtration, centrifugation and initial tangential flow filtration.
  • Performed product titrations, viral inactivation, neutralization and buffer additions.
  • Viral and sterile filtration.
  • Bulk drug substance fills in bio safety cabinet.
  • Followed all current good manufacturing practices (cGMP), batch records, operating procedures, work instructions and proper documentation.
  • Buffer formulation.
  • Cleaned and steamed in place various equipment.
  • Sampled drug substance and recorded in (LIMS).
  • Made assemblies and sterilized them in autoclave.
  • Ran automated parts washer cabinet.
  • Inventory management / resource planning using (JDE) and other manufacturing execution systems.
  • Operated pH / conductivity meters, spectrophotometers, sample diluters and osmometer.
  • Inspected and manually cleaned machines.

Education

Ivy Tech Corporate College
Bloomington, IN

Indiana State University
Terre Haute, IN

High School Diploma -

Owen Valley Community High School
Spencer, IN
05.2009

Skills

  • Good manufacturing practices (GMP)
  • Good documentation practices (GDP)
  • Aseptic technique
  • Visual inspection
  • ISO 5, 7, 8 level gowning
  • Buffer formulation
  • Bulk drug substance filling
  • Autoclaving (sterilization / decontamination)
  • Component prep / filter assembly
  • Cabinet parts washer
  • 5S Operational Excellence / lean manufacturing
  • Filter integrity testing
  • Sampling
  • Drug substance harvest / clarification
  • Centrifugation
  • Viral inactivation
  • Liquid chromatography (ProteinA, CEX, AEX, SEC, etc)
  • Multiple types of filtration (POD, Stax, Viral, Planova, Sterile)
  • Column packing
  • Tangential flow filtration
  • CIP / SIP (clean / steam in place)
  • JDE / MES / ASCTrac / SAP (software)
  • MODA (electronic / paper batch records)
  • LIMS (laboratory information management systems)
  • DeltaV / Unicorn (process control systems)

Certification

  • Certification in Basic Chromatography and Tangential Flow Filtration training from Ivy Tech Corporate College - 2014
  • Gold certificate in Applied Mathematics, Locating Information and Reading for Information from Indiana Workforce Development WorkOne - 2014

Timeline

Sr. Manufacturing Associate (Purification)

KBI
07.2022 - Current

Team Lead - Bulk Drug Substance Purification Downstream

Catalent Pharma Solutions
10.2017 - 08.2021

Manufacturing Associate Purification / Formulation

Cook Pharmica / Catalent Pharma Solutions
09.2014 - 10.2017

Ivy Tech Corporate College

Indiana State University

High School Diploma -

Owen Valley Community High School

Accomplishments

  • Authored 35 standard operating procedures (SOP's) and work instructions.
  • Supervised a team of 8 from engineering batches to commercial bulk drug production.
  • Improved batch records during engineering runs.
  • Investigated 21 deviations and formed a root cause analysis.
  • Managed key performance indicators (KPI's).
  • Oversaw a reduction in team deviations by 90%.
  • 0 safety incidents in 9 years.
  • Worked with cross functional teams to bring 2 drugs from clinical stage to commercial manufacturing.
Andrew Hershberger