Summary
Overview
Work History
Education
Skills
Leadership Style
Certification
References
Timeline
Generic

Faith Dial

Smithfield

Summary

Goal oriented and quality driven professional with over 21 years of industry experience, including 19 years in leadership roles focused on process, product, and personnel improvement. Demonstrated ability to build high-performing teams that exceed performance expectations. Strong expertise in project management, civil project execution, and cost minimization, with additional skills in surveying and pattern analysis. Recognized for exceptional multitasking, attention to detail, and enhancing team morale.

Overview

21
21
years of professional experience
1
1
Certification

Work History

LEAD ENGINEER I

Mural Oncology/Alkermes, Inc.
Waltham
12.2022 - Current
  • Ensured compliance with operational requirements across CMOs, including production planning and dispute resolution.
  • Oversaw quality assurance for externally manufactured products, ensuring adherence to documentation standards.
  • Collaborated with CMOs and internal teams to identify and mitigate risks in end-to-end supply chain.
  • Reviewed and approved GMP-related documents at CMOs to maintain regulatory standards.
  • Coordinated with Development and Quality teams to enforce external production operation instructions.
  • Led contract negotiations with CMOs in partnership with CMC Teams, Procurement, Legal, and Finance.
  • Established Key Performance Indicators for CMOs, facilitating process performance reviews.
  • Acted as primary contact for CMOs, ensuring on-time deliveries through strong relationship management.
  • Resolved complex technical issues through troubleshooting techniques and root cause analysis.
  • Prepared estimates and budgets.
  • Assessed risks associated with proposed changes or modifications to existing systems.
  • Coordinated activities with suppliers, contractors or other departments.
  • Managed capital improvement projects to keep expenses within operational budgets.
  • Managed cross-functional teams responsible for developing innovative solutions.
  • Finished projects on time and within budget.
  • Drafted proposals outlining cost estimates, timelines, and resource requirements for new projects.
  • Collaborated closely with team members to achieve project objectives and meet deadlines.
  • Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
  • Prioritized and organized tasks to efficiently accomplish service goals.
  • Recognized by management for providing exceptional customer service.

biomanufacturing Manager

biomason
Durham
01.2021 - 09.2022
  • Work closely with quality control personnel to review product consistency and appearance to produce products that meet or exceed company standards and consumer expectations.
  • Responsible for day-to-day management, setting objectives, coaching and developing employees, and performance appraisal of 4 employees.
  • Monitored and improved production yields to determine trends and areas of improvement that met company quality expectations.
  • Continuously met and exceeded production variance goals by making process improvements.
  • Monitored operation and maintenance expenses and researched ways to reduce cost while maintaining product quality and prevent downtime.
  • Maintained inventory adjustments and product scrap budget to a minimum.
  • Operated and monitored the operation of fermentation and biological processes that included the operation of microbiological bioreactors.
  • Built and maintained clear and accurate process documentation and records.
  • Implemented strategies for long-term traceability.
  • Learned the cost structure and identified opportunities for improvement.
  • Controlled incoming, in-line and final quality through process and equipment statistical process control (SPC).
  • Established and managed change control to ensure quality while balancing the need for innovation and continuous improvement.
  • Performed biomanufacturing scale-up from flask to 1L, 1L to 5L and 5L to 30L for several different strains.
  • Developed bioreactor optimization in the 5L and 30L.
  • Performed statistical analyses and interpreted data for actionable decision-making to transfer current product operations to Denmark.
  • Gave weekly meetings to executives providing key process input variables and the key process output variables for SPC.

PSS Manager

Eurofins Laboratories PSS
Sanford
08.2018 - 11.2020
  • Lead direct reports, group leaders and their teams and serve client in technical settings.
  • Oversee Site Contingent worker program (~70 employees) and have direct oversight of the following departmental employees: Manufacturing Science & Technology (MSAT), Quality Assurance (QA), Quality Control (QC), Supply Chain (SC).
  • Provides Quality leadership and direction to support business operations and development of the site quality strategy.
  • Conducts monthly meetings with each direct report and client managers.
  • Lead teams, makes schedules for leadership trainings and trains employees on administrative task.
  • Organizes technical resources and staff to make sure the client’s goals are accomplished.
  • Assists the Director with business operations when needed.
  • Stay current with science and technology by attending consortiums.
  • Ensures coverage is provided to assist in client meeting daily goals.
  • Ensures the necessary performance is provided by each direct report to assist in client meeting goals.
  • Relays any administrative communications to direct reports.
  • Handles Financial responsibilities such as Purchase Orders and invoices as provided by Director, maintains accounts up to $10M a year.
  • Promotes and demonstrates company vision to client and staff.
  • Developed effective relationships with local and global internal partners.
  • Responsible for the hiring, management and training of staff including resource utilization, definition of roles, career development and performance management in accordance with available budget, and resources.
  • Prioritizes departmental activities according to corporate objectives such as (Site safety, Employee Activities Committee (EAC) and LEAN Team.
  • Leads, participates and sponsors specific Quality related projects in accordance with the company’s goals and business objectives.
  • Participate in departmental growth and recommend/prepare and respect budgets according to corporate objectives.
  • Responsible for day-to-day management, setting objectives, coaching and developing employees, and performance appraisal of employees.

Group leader- manufacturing investigator

Eurofins Laboratories PSS
Sanford
10.2017 - 08.2018
  • Leads team, schedules, and train employees in client environment.
  • Ensures adherence to highest quality and efficiency standards in laboratory operations.
  • Ensures coverage and performance.
  • Fosters morale and teamwork.
  • Conduct manufacturing investigations to determine root cause, impact, and corrective actions/ preventative actions (CAPA).
  • Provide input on SOP’s, batch records, forms or other cGMP related documents developed or revised to support CAPA.
  • Possesses general knowledge of scientific principles, technical knowledge of production equipment and related procedures with emphasis on assigned production area.
  • Identifies technical problems and solves them with minimal guidance of supervisor.
  • Acts as a departmental liaison with primary support groups such as engineering, technical services, quality control, quality assurance, development and utilities with regards to investigations and CAPA implementation.

MANUFACTURING ASSOCIATE (contractor)

Seqirus (through Pro Unlimited)
Holly Springs
01.2016 - 01.2017
  • Provided the technical skill sets necessary to manufacture high quality biologicals and/or sterile injectables safely in a compliant, efficient, and cost-effective manner.
  • Supported projects of medium scope (e.g. Operational Excellence, safety).
  • Supported the collection and tracking of area metrics and process control data.
  • Supported a high-performance teamwork environment and demonstrated Novartis Values and Behaviors.

Supervisor, Manufacturing

Biogen
RTP
01.2010 - 11.2015
  • Promoted to role due to process technical knowledge, leadership traits and attributes.
  • Created a culture of disciplined execution and a high level of professionalism by observing, instructing, coaching, leading, and developing staff; built ‘balanced’ team.
  • Assured team of 10 (direct reports) were properly assigned to execute operating objectives; created mentor ‘buddy system’, assuring knowledge transfer and training in efficient timeframe.
  • Performed manufacturing activities per Good Manufacturing Practices (cGMPs) in both Upstream (Cell Culture) and downstream (Purification) processes; ensured teams were fully trained on a given activity prior to performing the activity.
  • Assisted in internal and external audits with BOH, EMA, FDA and other regulatory agencies.
  • Lead team in constructing, commissioning, validating and startup of new POD filtration systems.
  • Scheduled and directed daily manufacturing activities, timely communicating scheduling changes/issues to staff and management while supporting process technology transfers as well as process validation.
  • Adhered to Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations in daily operations as well as assisted auditors during on-site audits.
  • Reviewed and approved batch-related documents, Batch Production Records (BPRs), ensuring implementation and completion of proper cGMP documentation practices, validation activities, and corrective measures (Deviations & CAPAs).
  • Initiated, planned, executed, controlled, and closed validation protocols for Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ) equipment qualification as well as Deviations, CAPAs and Change Control documents.
  • Lead/Supported new campaign design, technology transfer and scale-up.
  • Developed new Clean in Place (CIP) route for new campaign that was inadvertently missed by Engineering to ensure sterile product and to prevent any contaminations to product.
  • Successfully completed validation projects for Automation Integration project first and second generations.

Manufacturing Associate IV/Team Lead

Biogen
RTP
01.2008 - 01.2010
  • Promoted due to excellence in operational improvement and smooth operations. Frequently stepped in as Acting Supervisor.
  • Designed and implemented Grass Roots Improvement Processes (GRIPs) which is a continuous improvement system for developing techniques to save time, money and manual labor.
  • Developed a system for Lean Manufacturing for all departments throughout company.
  • Designed first industry Integrity Test (IT) program for a 12-round linear filter housing.
  • Developed working relationships with management and supporting departments (Quality Assurance (QA), Quality Control (QC), Engineering, Manufacturing Sciences (MS), Maintenance, and Peers to build a rapport.
  • As SME, troubleshot equipment and assessed technical issues as they arose.
  • Maintained quality of operations, schedule of manufacturing activities, adherence to cGMP requirements.
  • Successfully completed validation projects for centrifuge, POD filtration skid and Dept filtration skid.
  • Authored and modified SOPs, CAPAs and Change Control documents.
  • Flagged, investigated and resolved process deviations.
  • Mentored and trained lesser-experienced Manufacturing Associates (Mas) and reported operator personnel issues directly to the supervisor as required.
  • Short term assignment to Cambridge, MA to support new equipment startup and train new employees.

Manufacturing Associate III

Biogen
RTP
01.2007 - 01.2008
  • Promoted; exemplified highly detail orientation with excellent documentation skills in solving issues and developing best practices.
  • Developed end of process air blow that saved approx. $150K per batch/$14.5M per year to harvest filtration systems.
  • Designed system to implement using Cedex in place of Coulter Counter to reduce human error and stabilize cell counts.
  • Perfected equipment such as: CEDEX, Blood Gas Analyzer (BGA), YSI, and aseptic technique.
  • Operation of various process equipment, execution of validation protocols, creating/revising cGMP documents and other assignments with minimal supervision.
  • International travel experience went to Denmark to support startup of new facility as well as train new employees and give presentations on new harvest equipment.

Manufacturing Associate II

Biogen
RTP
01.2004 - 01.2007
  • Brought on board in recognition of chemistry background plus solid production facility experience.
  • Hand selected for progression into team leadership responsibilities.
  • Learned and mastered guidelines within a GMP environment.
  • Assured application of knowledge and excellent performance according to SOPs.
  • Designed compact area for efficient and time saving sampling processing to reduce human errors in data transfer.
  • Organized scheduling of critical, time-crucial operations across 12-hour shift, including initial review of manufacturing procedures/batch records.
  • Drafted and revised complex technical documents and reports; proposed corrective action for Quality incidents.
  • Maintained keen eye on opportunity for process improvement.
  • Performed data analysis of critical process parameters, Assisted and planned improvement implementations.

Education

Master of Science - Organizational Leadership

Northcentral University
Scottsdale, AZ

Bachelor of Science - Chemistry

University of North Carolina at Pembroke
Pembroke, NC

Skills

  • Regulatory compliance
  • Quality assurance
  • Project management
  • Risk assessment
  • Data analysis
  • Process improvement
  • Team leadership
  • Contract negotiation
  • Supply chain management
  • Technical troubleshooting
  • Process documentation
  • Customer service
  • Relationship management
  • Problem-solving abilities
  • Adaptability and flexibility
  • Analytical thinking
  • Product development
  • Budget management
  • Continuous improvement and integration
  • Code compliance
  • Problem-solving aptitude
  • Design optimization techniques
  • Operations monitoring
  • Foster a positive work culture
  • Troubleshooting
  • Recruitment and team development
  • Ability to delegate and influence
  • Corrective action mentorship
  • Attentive to team stresses
  • Committed and responsible
  • Flexible and empathic
  • Ability to interact with diverse clients
  • Collaborate effectively with others
  • International travel experience
  • Possess a positive attitude, and optimistic outlook

Leadership Style

  • Foster positive work culture
  • Matrixed collaboration
  • Recruitment and team development
  • Highly organized with attention to detail
  • Time management
  • Superior Presentation Skills
  • Data & Statistical Analysis
  • Ability to Delegate and Influence
  • Corrective action mentorship
  • Open to New Ideas
  • Root cause analysis
  • Attentive to Team Stresses
  • Committed and Responsible
  • Flexible and Empathic
  • Ability to interact with diverse clients
  • Demonstrate personal initiative and the ability to problem solve
  • Ability to motivate self and others and influence
  • Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
  • Strong communication (verbal and written) and organizational skills
  • International travel experience
  • Possess a positive attitude and optimistic outlook

Certification

  • Notary Public

References

References available upon request.

Timeline

LEAD ENGINEER I

Mural Oncology/Alkermes, Inc.
12.2022 - Current

biomanufacturing Manager

biomason
01.2021 - 09.2022

PSS Manager

Eurofins Laboratories PSS
08.2018 - 11.2020

Group leader- manufacturing investigator

Eurofins Laboratories PSS
10.2017 - 08.2018

MANUFACTURING ASSOCIATE (contractor)

Seqirus (through Pro Unlimited)
01.2016 - 01.2017

Supervisor, Manufacturing

Biogen
01.2010 - 11.2015

Manufacturing Associate IV/Team Lead

Biogen
01.2008 - 01.2010

Manufacturing Associate III

Biogen
01.2007 - 01.2008

Manufacturing Associate II

Biogen
01.2004 - 01.2007

Master of Science - Organizational Leadership

Northcentral University

Bachelor of Science - Chemistry

University of North Carolina at Pembroke

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Faith Dial