Summary
Overview
Work History
Education
Skills
Timeline
Generic

Richard Wassmuth

Berthoud,USA

Summary

Seeking a challenging, dynamic and rewarding leadership role in the biotech/pharmaceutical/medical device industry with a successful, growth-oriented company.


I am a Manufacturing Professional with comprehensive background in overseeing production operations and quality control. Known for fostering collaborative team environments and driving operational improvements. Reliable and adaptable, with focus on achieving consistent results.

Overview

31
31
years of professional experience

Work History

Manufacturing Supervisor

AGC Biologics
11.2020 - Current
  • Early hire at site, involved all stages of start-up of new Active Pharmaceutical Ingredient Production Facility in Boulder, CO.
  • Worked with first signed customer to transfer existing Cell Culture process from AGC’s Copenhagen Facility to the Boulder Facility.
  • Screen, interview and hire prospective candidates for various Manufacturing positions
  • Worked with team of up to 11-14 staff to identify equipment needs and to author User Requirement Specifications for numerous pieces of production equipment. My team also worked successfully to source production / analytical equipment per User Requirement Specifications.
  • Successfully lead Manufacturing team in the Cell Culture production of Shakedown runs and Media trials, as well as GMP/PPQ lots, less than two years after acquisition of the site.
  • SME Reviewer/Approver of over 500 documents (SOPs, MPRs, Protocols and Validation) for the Cell Culture processes.
  • Work with staff across multiple departments to ensure a team-approach to the Site’s success.

Sr. Process Engineer / Acting AD

AMRI Pharmaceuticals
03.2018 - 05.2019
  • Direct strategic aspects and activities of the Technical Operations Group (TO), consisting of 10-12 Process Engineers performing Commercial Product (CP) support as well as New Product Introduction (NPI) support.
  • Screen, interview and hire prospective candidates for PE positions.
  • Create and implement short / long-term goals for the TO group, direct staff to expectations.
  • Lead strategic planning for the TO group to ensure success against metrics and in preparation of future growth.
  • Actively reviewing and seeking strategic initiatives that will improve existing production.
  • Regularly meet with existing and prospective customers to provide insight and direction for best process implementation and practices. Provide customers with facility tours and process capabilities in support of multiple parenteral drug products.
  • Partner with Process Engineers to develop robust equipment designs and processes for New Products (NPIs) and for existing Commercial Products.
  • Investigate Problem Reports (PRs) as needed. Perform Root Cause Analysis (RCA) using multiple methodologies, provide Corrective Actions and Preventative Actions and implement as needed. Ensure effective CAPA implementation and closure through the Trackwise system.

Production Manager

AMRI Pharmaceuticals
08.2014 - 03.2018
  • Manage/direct strategic aspects and activities of a multi-level group of 30 to 65 manufacturing personnel in routine final filling of multiple parenteral products on three aseptic filling lines (ISO 5 / Grade A environments).
  • Create short and long-term goals (Key Performance Indicators, Management By Objectives) for manufacturing group, direct staff to expectations.
  • Participate in customer and regulatory audits, assist with responses and actions plans to observations as needed.
  • Participate in New Product and New Equipment Introductions, providing Subject Matter Expert input to process life-cycle
  • Identify, initiate and investigate Problem Reports (IR/NC) as needed. Perform Root Cause Analysis (RCA) using multiple methodologies, provide Corrective Actions and Preventative Actions. Ensure effective CAPA implementation and closure through the Trackwise system.
  • Involved in strategic planning process for site (growth/profitability of existing contracts, new contracts and new technologies).
  • Regularly meet with existing and prospective customers, provide facility tours and process capabilities in support of multiple parenteral drug products.
  • Implemented a safety awareness program to drive a culture of continuous improvement.

Supervisor

Tolmar Inc.
09.2010 - 08.2014
  • Daily supervision of 30 to 45 full-time and contract-manufacturing personnel, in all phases of production, for over 20 dermatological and ingestible (raw material dispensing, bulking, filling, final packaging).
  • Supervised manufacturing of Eligard (Syringe A) medical device product, using INOVA syringe filling equipment. Process also included product compounding, tray-packing steps and final cartoning steps for both A and B syringes.
  • Reviewed completed batch records, identified errors and obtained corrections as needed. Provided sign-off as final manufacturing reviewer, prior to Quality Assurance review.
  • Responded to and assessed Building Management System (BMS) alarms, production-equipment alarms, general process issues and contact appropriate support staff when needed.
  • Revised Manufacturing Procedures, Standard Operating Procedures (SOP) and training documents as needed.
  • Identified and initiated non-conformances (IR’s, NC’s) as needed. Investigated incidents and determined Root Causes, Corrective Actions and Preventative Actions. Ensured effective CAPA implementation and closure.
  • Performed regular one-on-ones with staff, including year-end reviews. Provided goals, development plans and training for staff on a regular basis. Involved in various projects to improve processes and safety at all steps, reduce Non-Conformances and improve overall quality of product.

Consultant

Maetrics LLC
03.2009 - 01.2010
  • Manager of several projects for Cephalon Inc. (a client company) at their Salt Lake City Production Facility.
  • Successfully completed Cross Contamination Remediation Project in June, 2009 for a facility handing DEA Schedule 2 solid-dose Fentanyl product in multiple presentations.
  • Duties included: completion of risk assessment of all Q7A-relevant production functions for potential cross contamination of products, excipients and related Active Pharmaceutical Ingredients (API), in relation to client’s manufacturing expansion project.
  • Completed Failure Mode and Effects Analysis (FMEA) on all aspects of production. Provided remediation recommendations for high-risk issues. Recommended client implement a Quality Risk Management / Quality Management Systems (QRM/QMS) approach to production, per the “International Conference on Harmonisation” (ICH) “Q9” and “Q10” guidelines.
  • Completed implementation of QMS approach to production, in conjunction with client’s manufacturing expansion project. Tasks included: major re-write and/or creation of over fifty SOPs, work instructions (WI) and policies.
  • Provided recommendations on expansion designs and associated utility/production equipment. Provided training to management and production personnel on implemented procedures as required.

Senior Manager, Production

Amgen Colorado
08.2006 - 03.2008
  • Successfully managed a multi-level and multi-function department within a multi-host, multi-product biotech manufacturing facility (production support/sanitation activities, raw material sampling, warehouse and contractors; 35-40 staff in total).
  • Ensured staff and contractors performed tasks as required by SOPs, documented practices and Environmental Health and Safety requirements.
  • Implemented improvements to various procedures and processes within organization, including: SOPs, safety and training programs, NC reductions and requalification/cleaning reductions.
  • Owned Non-Conformance investigations through life-cycle as needed (initiation through closure).
  • Led or participated in a number of projects including: SAP software implementation, task/cost reductions and shutdown planning. Led cross-departmental production/building utility meetings on a weekly basis.
  • Routinely coached staff and prepared them for regulatory inspections. Successfully participated in numerous regulatory inspections as lead presenter for dept.
  • Completed interviews and hiring of new staff as required. Set annual goals for department and supervised/managed staff to expectations. Routinely performed one-on-ones, quarterly coaching and annual reviews with direct reports. Performed strategic key-level meetings with floor staff on a regular basis.
  • Calibrated staff against goals, budgeted increases, bonuses and long-term incentives on an annual basis.
  • Successfully managed department budgets surpassing two million dollars (in total), including; employee compensations; Production and Support budgets. Actively managed budgets to surpass corporate goals every quarter. Provided site senior management with quarterly budget updates (as measured against group goals).
  • Facility Access Manager for Colorado sites. Tasks included approving elevated access to critical areas of the plant for all staff and contractors (700+ personnel), performing periodic audits of accesses, improvements to access processes and related Standard Operating Procedures.

Supervisor I, II Cell Culture Manufacturing

Amgen Colorado
06.2003 - 08.2006
  • Managed manufacturing personnel in the operations and bulk cell culture production of Epogen and Aranesp drug products. Directly responsible for the following processes: Vial Thaw, Scale Up, Bioreactor, Media Preparation, Roller Bottle Machine (Grade A / ISO Class 5 environment), Automated Roller Bottle System (ARBS) and Harvest/Dia-filtered Media operations (Ultra-filtration/Dia-filtration).
  • Additional management tasks included: Glass wash/Autoclave; Clean-in-place (CIP) and Steam-in-place (SIP) operations, routine periodic validation sampling/execution for all phases of production and equipment.
  • Routinely reviewed Cell Culture Batch Records and coordinated sign-off with Quality Assurance.
  • Conducted shift-change meetings with oncoming Managers. Responded to Building Management System alarms (BMS), production-equipment alarms (SCADA), general process issues and contacted appropriate support staff or management when needed.
  • Revised Manufacturing Procedures, SOPs and Training Documents as needed. Identified, generated and investigated Non-Conformances as needed.
  • Performed regular one-on-ones with staff, including year-end reviews. Provided goals, Development Plans and training for staff on a regular basis. Involved in various projects to improve processes and safety at all steps, reduce Non-Conformances and improve overall quality of product.

Manufacturing Associate II (Shift Lead)

Amgen Colorado
09.2002 - 06.2003
  • Performed general operations of cell culture processes, including: vial thaw, scale up, fermentation processes, media preparation, roller bottle (Grade A environment) and harvest/dia-filtration operations.
  • Performed work-in-progress lab support, Roller Bottle Machine set-up (dry run, fill compensation, sampling, etc) and provided RBM process support (Environmental Monitoring sampling, alarm/crash response).
  • Performed CIP/SIP tasks on equipment used in all stages of production. Routinely diagnosed and corrected equipment errors and/or failures.
  • Performed glass wash/autoclave functions as needed.
  • Additional process tasks included: roller bottle inspection, automation support, drive station support, diafiltered media bottling.
  • Revised SOPs as needed. Identified and generated Non-Conformances as needed.

Associate I, Associate II, Environmental Monitoring (EM) Lab Lead and Water Labs

Amgen Colorado
05.1999 - 09.2002
  • Supervised daily activities of two direct reports, as well as daily operation of Environmental Monitoring (EM) Lab.
  • Provided training for Manufacturing/Quality Control personnel on gowning practices, EM equipment use, routine EM/Water sampling, In-Process sampling and aseptic technique.
  • Acted as the main QC Microbiology/EM Lab representative in departmental/cross-departmental meetings.
  • Generated Alert/Action notifications, Incident Reports and conducted investigations as necessary. Coordinated non-routine (Investigational) sampling as needed.
  • Participated in regulatory inspections as lead presenter of EM lab functions.
  • Acted as the EM/Water Project Manager for plant shutdowns. Led numerous projects and Study Protocols.
  • System Owner for 50 pieces of lab equipment (sampling equipment, incubators, etc.).
  • Revised SOPs, training modules and paperwork as needed. I performed one-on-ones, annual reviews and training documentation review for direct reports.
  • Performed bio-burden assays, water sampling and testing (pour plate and membrane filtration), EM sampling as necessary.

Lab Tech II, Lab Tech III, Associate I, Environmental Monitoring (EM) and Water Labs

Amgen California
09.1996 - 05.1999
  • Scheduled and performed Post Sanitization, Requalification and routine EM and Water sampling.
  • Performed routine Compressed Air/Gas and Aseptic Gowning Monitoring.
  • Completed routine Installation, Operational and Performance Qualifications of viable and non-viable air sampling equipment.
  • Gained extensive proficiency with SQL Laboratory Information Management (LIMS) systems.
  • Performed Alert/Action notification procedures and Non-Conformance investigations as needed.
  • Completed revisions of SOPs as needed. Participated in company “Y2K” Initiative and rollout.

General Manager

Golf Club Factory Outlet
09.1994 - 09.1996
  • Hire, train, and schedule and supervise 15 personnel. Performed general operation of retail store including daily reconciliation, opening & closing procedures, cost controls, customer relations and negotiations, credit reports, marketing of merchandise, banking, ordering of supplies and inventory control.

Education

Physics, Engineering

Front Range Community College
Longmont, CO

Computer Network Engineer (CNE), Engineer (MCSE) - undefined

LT University (non-accredited)
Northridge, CA
01.1997

Computer Science

Moorpark College
Moorpark, CA
01.1985

Diploma - undefined

Thousand Oaks High School
Thousand Oaks, CA
01.1982

Skills

  • Experience in SCADA Systems, SQL LIMS, MAXIMO Work Order System, SmartSolve, TrackWise, Microsoft Office and Brio Query Designer
  • Lean manufacturing principles, eg 5S, Value Stream Mapping
  • Operational Enhancements / Process Improvements
  • Skilled at executing regular safety audits
  • Staff Development
  • Quality Assurance

Timeline

Manufacturing Supervisor

AGC Biologics
11.2020 - Current

Sr. Process Engineer / Acting AD

AMRI Pharmaceuticals
03.2018 - 05.2019

Production Manager

AMRI Pharmaceuticals
08.2014 - 03.2018

Supervisor

Tolmar Inc.
09.2010 - 08.2014

Consultant

Maetrics LLC
03.2009 - 01.2010

Senior Manager, Production

Amgen Colorado
08.2006 - 03.2008

Supervisor I, II Cell Culture Manufacturing

Amgen Colorado
06.2003 - 08.2006

Manufacturing Associate II (Shift Lead)

Amgen Colorado
09.2002 - 06.2003

Associate I, Associate II, Environmental Monitoring (EM) Lab Lead and Water Labs

Amgen Colorado
05.1999 - 09.2002

Lab Tech II, Lab Tech III, Associate I, Environmental Monitoring (EM) and Water Labs

Amgen California
09.1996 - 05.1999

General Manager

Golf Club Factory Outlet
09.1994 - 09.1996

Computer Network Engineer (CNE), Engineer (MCSE) - undefined

LT University (non-accredited)

Computer Science

Moorpark College

Diploma - undefined

Thousand Oaks High School

Physics, Engineering

Front Range Community College

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