Process Development Scientist

Location:

Olney, MD, 20832

Posted:

September 04, 2025

Contact this candidate

Resume:

Ritchie Vehemente

***** ******* ***** ******* *****, MD 20832

301-***-**** Mobile, **********@*****.***

Overview

I have been in the biopharmaceutical industry since July 2006. I started as a Manufacturing Associate I and had worked my way up to a Mfg Assoc IV / shift lead position. In Mar 2016, I transitioned over to Process Development (PD) as an Associate Scientist and have progressed to a Scientist II. Currently, I work remote primarily focused on the extractables and leachables (E&L) program at ADMA Biologics. Working in a current good manufacturing practices (cGMP) setting has provided an environment for collaboration and teamwork. My goal every day is to put forth my best effort, contribute wherever I can by utilizing my experience, and to continuously learn along the way while having a positive influence on those I interact with. My preference is to continue full-time remote work due to family commitments. As a result, I am open to any line of work which would accommodate that. Fortunately, I can always rely on my range of experience to adapt to whatever responsibilities are required.

Education

Montgomery College – Germantown, MD: January 2003 – May 2005

Certification in Biotechnology

University of Maryland at College Park: September 1992 - May 1996

Bachelor of Science Degree in Accounting with Double Major in Finance

Computer Skills

Working knowledge of:

Microsoft 365 apps including Excel, Word, PowerPoint, Outlook, Teams, SharePoint; Adobe Acrobat Sign

Smartsheet, Box

Laboratory Information Management System (LIMS)

Systems, Applications, & Products (SAP) Fiori, SAP Concur

Blue Mountain

Soft Expert

Unicorn software to chromatography systems and DeltaV user interface for process equipment

Work Experience

ADMA Biologics, Inc. (acquired Biotest Pharmaceuticals) – Boca Raton, FL (work remote in Olney, MD)

Scientist II then retitled to Administrative Engineer as a result of remote assignment, Process Development – March 2016 to Present

Primary responsibility is with extractables and leachables (E&L) program and assessing vendor change notifications with occasional travel to Boca Raton, FL site as needed to assist in development scale studies

Coordinate E&L studies and master service agreements with contract labs

Purchase inventory, parts, and supplies needed for analytical testing and various laboratory studies through SAP and online vendor accounts including capital expenditures

Write up change control proposals, change controls, and assist with deviation investigations

Create, revise, and review standard operating procedures (SOP), batch records, and protocols

Execute entire small-scale manufacturing process from fractionation to purification for optimization and investigational purposes including the make-up of various buffers and performing product filterability

Maintain various equipment including pH and conductivity meters, benchtop scales, chillers, flow-through centrifuges, ultrafiltration/diafiltration systems, chromatography columns, spectrophotometers, and plate washer and readers including oversight of equipment preventive maintenance schedules through Blue Mountain software

Process lab samples through LIMS and perform analytical methods such as enzyme-linked immunosorbent assays (ELISA) while maintaining laboratory notebook

Collaborate with other departments including Environmental Health and Safety, Facilities, Manufacturing, Metrology, Purchasing, Quality Assurance, Quality Control, Supply Chain, and Legal

Biotest Pharmaceuticals Corp. (acquired by ADMA Biologics, Inc.) – Boca Raton, FL

Manufacturing Tech – March 04, 2013 to March 2016

Part of monoclonal antibody upstream clinical manufacturing group

Responsible for operation and maintenance of 2200 L production bioreactor, decontamination system, clean in place (CIP) cart, glasswasher, and autoclave

Supported Process Engineering, Automation, Metrology, Validation, Facilities, and contractors with maintenance of process equipment and analytical instruments

Assisted with media and buffer formulations

Monitored and maintained environmental chambers and gas supply tanks

Assisted with change control and deviation write-ups

Revised production batch records and SOPs

Tracked and updated raw materials, stock solutions, inventory, and process orders through SAP

Assisted finance department with month end confirmations of production costs

Supported cleaning validation with fractionation data collection, reviewing performance qualifications, and drafting final reports as part of remediation efforts

Performed routine safety monitoring of production area

Human Genome Sciences, Inc. (acquired by GlaxoSmithKline) - Rockville, MD

Lead Biopharm Manufacturing Associate – July 24, 2006 to February 21, 2013

Supported commercial, contract, and clinical upstream mfg. operations for biopharmaceutical company

Performed biosafety cabinet, bioreactor, and harvest activities in a cGMP clean room environment which included a production train ranging in size from 25L to 20,000L

Performed aseptic operations involving mammalian cell culture

Operated bioreactor, add tank, centrifuge, and depth filter equipment including CIP, steam in place (SIP), cleaning validation, and tank entries

Operated and maintained analytical instruments such as Vi-Cell & Cedex cell counters, YSI bioanalytical system, filter integrity tester, blood gas analyzer, Rosemount analyzer, conductivity meter, pH meter, and dissolved oxygen (DO)/pH probes

Filter integrity tested gas, liquid, and capsule filters

Led the shift by coordinating daily floor activities, conducting shift change meetings, training new associates, and providing feedback on potential hires

Ensured a safe working environment within production suites

Coordinated with Engineering, Facilities, Metrology, and Process Controls in the maintenance and troubleshooting of the various skids

Drafted, revised, and reviewed standard operating procedures, work instructions, batch records, & logbooks

Assisted in deviation write-ups

Ensured equipment, production suites, trainings, and documents were audit ready and compliant

Interacted with international drug agencies by executing production operations during their audit

Participated in tours of our large-scale facility with new hires. Tours also included high school & college classes and local government officials.

Contributed in one of the company's FDA approved drugs starting with engineering runs to conformance runs and an 80+ cGMP commercial run campaign

Cross trained with large scale downstream manufacturing group

Worked with process development on contract manufacturing harvest process

Participated in several video sessions as part of internal training and outside marketing efforts

Pre-July 2006 jobs encompassed accounting / finance positions. History detail available upon request.

References

Claudia Johnson

Former Senior Manager – Process Development