Adam Pfeifer Email and Phone Number
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I am a Technical leader who drives success and directs high-producing teams while developing employee dependability. Experienced in Lean Six Sigma and Operations to reduce costs and streamline production processes, managing in a team setting, and managing projects across various sectors covering multiple contexts. My focus is on facilitating the creation of quality products to meet customers’ expectations and achieve company goals.
Critical Mass Consulting, Llc
View- Website:
- criticalmass-consulting.com
- Employees:
- 12
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Critical Mass Consulting, LlcLos Angeles, Ca, Us -
Product Development Expert Team (Pdet) ManagerCsl Apr 2023 - Dec 2024Melbourne, Victoria, Au• Support Tech Transfer Leads, CMC Leads, Biopharmaceutical Process Development departments, and external testing laboratories to ensure success of BPD projects.• Assist in the planning and coordination of the transfer of cell therapy related processes, including analytics between CSL sites and from and to external partners.• Coordinate and outsource activities including analytical support, custom raw material manufacture, and equipment evaluations.• Manage Tech Transfer projects, set goals, measure progress against formal protocols while maintaining relationships with all partners.• Ensure the requirements of projects, internal customers, and external customers are met concerning quality, cost, and timelines.• Guide R&D policy, help prepare regulatory packages, and identify new opportunities for cost savings and process efficiencies through exposure to the product development pathway and global bio-pharmaceutical trends.• Lead Product Development Expert Team (PDET) meetings, including provision of agendas, actions, and minutes.• Collaborate with department managers, CMC leads, and global project managers to develop detailed PD specific project plans.• Write formal transfer protocols with measured deliverables and document project closure/completion through formal reports.• Create cost estimates for projects for internal and external customers, provide budget forecasts, and maintain tracking of ongoing project costs. -
Technical Operations ManagerCsl Oct 2021 - Apr 2023Melbourne, Victoria, AuManaged the Tech Ops Engineers (2) while applying scientific / technical and management skills to ensure that the operating environment within the Pasadena facility was maintained and developed to fully support the success of the CSL Gene Therapy Research & Development Group activities.• Developed and managed the Capital project program for the Pasadena site. Program included but was not limited to:o Project charters and approval processo Project execution processo Project status monitoring/updates processo Project closure processo Ensured process alignment w/ global standards/timelineso Completed > 80% of project deliverables on time o Completed > 80% of projects within budget margin• Implemented stakeholder site meetings with the labs to ensure customers were engaged with the Operations group and site communications were sharedo Ensured timely communication of all regulatory changes• Maintained performance against EHS departmental leading KPIs• Completed departmental risk profiles with the support of the EHS business partner (Triumvirate Environmental Inc, TEI)• Participated in routine inspections of the Lab areas with TEI• Responsible person at the Hill Site for COVID guideline implementation for businesses at the direction of City of Pasadena and Public Health Department• Reported, assessed and closed > 75% of the EHS incidents within assigned due date • Completed ergonomic assessments/improvements• Proactively supported the Site Leadership Team and contributed to improving and maintaining CSL culture and values on site• Identified improvement opportunities for Site Operations and redundancy in Site and GMP operational processes• Reviewed effectiveness of SAP asset management system and identified areas of improvement• Networked with operations and key stakeholder groups and peers at other sites to align Pasadena with CSL best practices/business modelso Implemented a Global lab operations team meeting to ensure this was accomplished -
Laboratory ManagerCsl May 2021 - Oct 2021Melbourne, Victoria, AuManaged a team of 5 direct reports while applying scientific / technical and management skills to ensure that the operating environment within the Pasadena facility was maintained and developed to fully support the success of the CSL Gene Therapy Research & Development Group activities.• Managed the regulatory requirements of the facility in relation to biosafety, environmental health and safety (EH&S), hazardous chemicals, regulated substances, recombinant DNA technology and quarantine activities, ensuring audit compliance• Served as the Biosafety Officer for the Pasadena facility o Communicated any issues/changes in biosafety, EH&S, and regulatory requirements to the Research Group o Ensured laboratory support activities such as waste collection and disposal, supply of buffers and delivery of consumable items were maintained o Managed all issues relating to State and Federal regulatory bodies to ensure that regulatory requirements relating to laboratory functions were met• Managed the procurement and inventory processes within the Research & Development Group including consumables and equipment• Authored and revised technical and training documents and reports• Represented the Gene Therapy Research & Development Group at various CSL committees that relate to regulatory activities• Contributed to the establishment, maintenance and management of CSL Gene Therapy research resources within the Pasadena facility o Identified and communicated resourcing issues to Senior Management and relevant senior scientific staff o Provided quality scientific and technical input into analysis of the required resources for ongoing and future R&D activity within the CSL Gene Therapy Research group o Identified and implemented appropriate cost and time saving measures• Assisted with the development and monitoring of the Gene Therapy Research & Development Group budget• Developed and maintained relationships with key external personnel -
Supervisor Ii, Facilities & MaintenanceBaxter International Inc. Apr 2019 - May 2021Deerfield, Illinois, UsManaged a team of 7 direct reports to maintain, improve and control the safe and efficient functioning of the plant manufacturing and facilities equipment. Established and managed preventative maintenance systems, schedules, and documentation while also managing all programs pertaining to the areas of safety, quality, cost, and productivity within the department.• Lead the Facilities and Maintenance teams to 17 consecutive months of preventative maintenance performed on time• Owned and closed the Preventative Maintenance CAPA, one of the most critical CAPAs to the plant with 7 gaps identified and 31 actions implemented• Coordinated and led the 2019- and 2020-year end maintenance activities with cross functional departments to ensure timeline of all repairs and modifications were done in the timeframe allotted with no impact to the production schedule• Oversaw day-to-day Facilities and Maintenance activities/execution of cGMP standards and procedures• Accomplished site/department goals of reducing incidents by implementing proactive safety improvements to the manufacturing suite and site• Implemented process to prioritize and address facilities related ad hoc requests• Managed top plant priority projects from inception through validation (IQ, OQ, PQ) and implementation for production and facilities equipment• Obtained Lead Auditor certification as part of Baxter’s Internal Audit Quality and Compliance program• Obtained Lean Six Sigma Green Belt certification in May 2019 – o Increased throughput (3,833/shift) and efficiency (105%) for the Intermate Manufacturing line ($60K annual savings)• Obtained Lean Six Sigma Black Belt certification in November 2020 – o Elimination of manual printing process with print/apply labeling technology ($231K annual savings). o Reduced Overtime in the Facilities department by 486 hours/year ($31K annual savings). o Reduced Overtime in the Maintenance department by 189 hours/year ($12K annual savings) -
Supervisor I, ManufacturingBaxter International Inc. Jun 2017 - Apr 2019Deerfield, Illinois, UsManaged a team of 78 direct reports, ensuring the ongoing validated state of commercial cGMP manufacturing processes as it relates to process execution and performance.• Lead the operations team to 15 consecutive months of positive manufacturing variance which resulted in $870K total income for Irvine in 2018 and $160K income for Q1 2019• Lead the operations team to 15 consecutive months of labor efficiency >100% which resulted in $250K additional income for the site in 2018 and $15K in Q1 2019• Oversaw day-to-day manufacturing operation activities and verified execution of cGMP standards and procedures o Developed, coached and mentored staff members through routine 1-on-1 interactions, performance management, and well-defined responsibilities o Oversaw day-to-day manufacturing operation activities and verified execution of cGMP standards and procedures o Ensured personnel with fully supported compliance-based activities by maintaining up-to-date training requirements o Promoted independent decision-making skills by empowering direct reports to make level-appropriate decisions• Accomplished site and department goals of reducing incidents by implementing proactive safety-related improvements to the manufacturing suite • Ensured the production schedule was met with well-balanced shift levels through staffing and resource allocation models -
Operations Supervisor, Ava ManufacturingEmergent Biosolutions May 2016 - Nov 2016Gaithersburg, Maryland, Us"At Emergent, we pursue innovative ways of using the immune system to prevent or treat life threatening diseases. Whether it is developing vaccines and therapies that can make a better life for millions of adults and children or providing the world’s only FDA-licensed anthrax vaccine to protect against anthrax infection, we are passionate in pursuit of our mission—to protect life."Oversaw the on-going validated state of the commercial cGMP manufacturing process for production of Anthrax Vaccine Adsorbed by managing a team of 9 direct reports in daily production task execution. Participated and provided subject matter expert resources in support of all regulatory audits and technical discussions during FDA inspections. Created and implemented a team charter to select and develop technicians through an educational experience and on-boarding program. Performed investigations of non-conforming events for root cause, assessing impacts and implementing corrective actions preventing future non-conforming events. Assisted with and contributed to the implementation of routine and complex process improvement, document and change initiatives. -
Team Leader, Ava ManufacturingEmergent Biosolutions Feb 2015 - May 2016Gaithersburg, Maryland, UsIndependently made process decisions while directing the activities of manufacturing technicians, ensuring production schedule requirements were met. Ensured scheduling and execution of Batch Production Records, product development protocols, technical studies and corrective/preventive maintenance. Performed Operations functions including real time Batch Production Record review, production shift scheduling, and quality investigations.Provided input and feedback for performance management of Manufacturing Technicians. -
Senior Technician, Aseptic/Downstream ProcessingEmergent Biosolutions Jan 2014 - Feb 2015Gaithersburg, Maryland, UsExecuted precise aseptic processing tasks for intermediate and sublot production.Trained Technician and Assistant Technician level personnel. Verified Facilities department execution of preventive/corrective maintenance on Upstream and Preparation related equipment. Proactively recognized potential issues with the manufacturing process equipment and systems and troubleshot in collaboration with Facilities/Maintenance.Participated in Value Stream Mapping and Kaizen events for streamlining manufacturing processes. -
Technician, Ava ManufacturingEmergent Biosolutions Sep 2012 - Jan 2014Gaithersburg, Maryland, UsLoaded, ran and unloaded sterilization and decontamination autoclaves using specific, validated load configurations per Standard Operating Procedures.Assembled clean process glassware configurations and portable tanks utilizing sanitary connections, quick connects and stainless steel ancillary parts.Interfaced with Data Acquisition System (DAS) and manipulated valve configurations, facilitating Steam In Place (SIP) of manufacturing production train ports.Manually cleaned process equipment including 10 L and 100 L bioreactors, Holding Tanks, and glassware per validated equipment cleaning procedures consisting of precisely timed step execution and measured chemical concentrations. -
Assistant Technician, Ava ManufacturingEmergent Biosolutions Oct 2011 - Sep 2012Gaithersburg, Maryland, UsManually cleaned process equipment including 10 L and 100 L bioreactors, Holding Tanks, and glassware per validated equipment cleaning procedures consisting of precisely timed step execution and measured chemical concentrations.Loaded, ran and unloaded parts washer using specific validated load configurations per Standard Operating Procedures.Performed bubble point integrity testing of hydrophilic and hydrophobic production filters using defined test programs. Stocked gowning and consumable supplies in the controlled areas maintaining Just-In-Time inventory (JIT) control of manufacturing materials. -
Operator / Administrative AssistantEc Applications May 2009 - Aug 2009Anaheim, Ca, UsWorked on various job sites in Arizona, California, and Hawaii.Operated plastic welders, leisters, and plastic sanding tools to make various forms of liners (Floating covers, Landfill Lining Systems, and Water Reservoirs).Sent out fax invoices to partnering companies and set up conference calls to determine how jobs would be done, and at what price.Developed good interpersonal skills along with a great experience to build myself as an individual in the workplace. -
PainterStudent Painters Jun 2008 - Aug 2008Shelby Twp, Mi, UsWorked on various houses around the Alpena area, all differing in size and difficulty.Prepped the houses for painting (Chipped off all old paint, and smoothed all the edges of the chipped paint prior to painting).Primed and painted the houses.Used many different ladders to paint the high hard to reach places.Detailed the houses in the intricate and hard to reach places such as window cills and peaks, which required more responsibility and expertise.
Adam Pfeifer Skills
Adam Pfeifer Education Details
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Michigan State UniversityHuman Biology -
Alpena High SchoolGeneral Studies
Frequently Asked Questions about Adam Pfeifer
What company does Adam Pfeifer work for?
Adam Pfeifer works for Critical Mass Consulting, Llc
What is Adam Pfeifer's role at the current company?
Adam Pfeifer's current role is Product Development Manager.
What is Adam Pfeifer's email address?
Adam Pfeifer's email address is ad****@****ter.com
What is Adam Pfeifer's direct phone number?
Adam Pfeifer's direct phone number is +198925*****
What schools did Adam Pfeifer attend?
Adam Pfeifer attended Michigan State University, Alpena High School.
What are some of Adam Pfeifer's interests?
Adam Pfeifer has interest in Working Out, Professional Networking, International Travel, New Technology, See Less, Many Others, Gourmet Cooking, Anything Outdoors, Running, Sports.
What skills is Adam Pfeifer known for?
Adam Pfeifer has skills like Leadership, 5s, Gmp, Teamwork, Kaizen, Lean Manufacturing, Kanban, Sap, Lims, Quality System, Standard Operating Procedure, Value Stream Mapping.
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