1. Brenda Hugh
Highly Effective Manufacturing/Quality Manager, Specializing
in Technology Transfer, Lean Manufacturing and Quality
Systems
2. Brenda Hugh– Presentation
Topics
• A Manufacturing Management Centric Career
• Career Highlights
• A Career Focused on Product Quality and Customer Satisfaction
• Some Common Interview Questions
• Example Manufacturing Manager 90-day Plan
• Qualifications Summary
3. Brenda Hugh– A Manufacturing Management Centric Career
Charles Stark Draper Laboratories 1988-2001 SRU Biosystems 2001-2012
Design and development of novel, ultra-reliable, miniature Label-free biosensor technology that enables
diagnostic, therapeutic, and chemical-biological sensors. detection of a variety of biomolecular interactions
• Fabrication leader for micro-mechanical chemical sensor including Biochemical and Cell-based applications.
• Responsible for providing leadership, guidance, and direction regarding • Manufacturing manager of biosensor product from
product and process development inception to current product line
• Lead effort for compliance with company's ISO Quality Management • Recognized leader for critical projects and
System strategies for ensuring product quality. Designed
• Developed and implemented highly manufacturable silicon-on-insulator and implemented in-coming, in-process and final
fabrication process for production of chemical sensing quality control procedures
• Demonstrated breakthrough multi-element array technology (8-element • Ensured all operations and documentation
and 64-element) based on existing dual-element array process conform to cGMP standards and all SOPs and
• Created and implemented new, highly effective system for establishing batch records are maintained to reflect current
and maintaining safe operations in a fast-growing, state-of-the-art manufacturing methods and are in conformance
development laboratory with FDA, ISO 9001 and 13485 compliance
• Leader of technology-transfer for biological and
chemical surface coating methods to
manufacturing operations
• Design and executed small-scale experiments
(DOE) and data analysis to support CAPA
investigations, change control and continuous
improvement projects to improve process
robustness/capacity/productivity
• Responsible and accountable for deliverables and
customer satisfaction, that they are on time and
within budget
Experience Highlights
• Career focused on product management and quality systems
• 20+ years prospecting, identifying needs, providing value
• Results and Science driven
• Team player with experience on multidisciplinary teams
• Confident and ethical
• Self-motivated and disciplined
• Advanced knowledge of quality system management (i.e. FDA
cGMP, ISO quality systems)
4. A Career Focused on Product and Customer Satisfaction
Proactive Leader of Premium Products
• Ability to understand customer needs and product performance
• Identified training needs, making certain that all personnel are trained to
adequately perform their assigned responsibilities
• Defined physical requirements of device and identified performance and
integrity criteria
• 100% testing of each phase of batch production
• Ensured all operations and documentation conform to cGMP/FDA/ISO
9001 standards and all SOPs and batch records are maintained to
reflect current manufacturing methods and are in conformance with
standards
• Drive yield and process improvements based on collected and
analyzed data
A wide scope of laboratory and life science knowledge & experience, working with
customers to identify needs, provide solutions, and deliver quality products
6. Some Common Interview Questions
What is your leadership style?
• Key personal objective is to earn the trust, confidence and respect of
the employees, organization, and our customers
• Demonstrate a genuine appreciation and support for employees. Focus
on the positives while understanding and communicating negatives in a
positive way. Recognize and celebrate success, learn from failures
• Ensure that employees feel valued and respected, and understand how
their efforts are contributing to the success of the organization
• Empower employees, achieve organization excellence through the
collaborative skills and experience of the entire team
• Regular meetings are held to discuss solutions to problems not
focusing on problems at hand
• Lead by example, with respect, integrity and honesty, deliver to
commitments, champion data-driven decision making / problem solving
All the above, will lead to motivation of team members and
success for the entire organization
7. Some Common Interview Questions
What are some of your basic beliefs?
• Communication is the key to success
• Employees want to be appreciated. A simple “Thank You” or note to a
colleague can go a long way.
• Training of processes early will lead to a smooth transition later
• Process improvement needs to be constant and ongoing. New
processes for better ways of doing things should be encouraged and
rewarded. Affect lasting change through a series of “small wins”,
recognizing and communicating achievements, with a vision for future
improvements and successes.
• Customer loyalty is achieved by earning their trust, confidence and
respect through honest business / personal relationships and by
consistent, timely and responsive delivery of exceptional quality
products, services and support
8. Some Common Interview Questions
How would others describe you?
• Trusted decision maker
• Proactive
• Engenders a culture of "get it done and get it done well"
• Very committed to the success of the team and organization
• Orderly, precise, disciplined, and deliberate
• Methodical problem solver
• Flexible, adaptable
• High integrity and ethics
• Strong business acumen
• Grounded, excellent team player, always willing to help others
• Very intuitive (anticipates others’ needs)
• Perseveres; Always follows up when she says she will
• “Leads by example”
• “Very well respected by other colleagues and managers”
• “An asset to any organization that she is a part of”
9. Some Common Interview Questions
What do people like most about you?
People find me likeable, down to earth, always willing to help, able to
sense someone’s need and provide proactive help / information, the quality
and thoroughness of my work / contributions, my attention to detail, helping
others learn / understand something new, educating them in the course of
their being helped; people find me easy-going yet determined and
motivated
What are your weaknesses?
An impatience for mediocrity, ineffectiveness and complacency (accepting
the status quo)
10. Some Common Interview Questions
What achievements are you most proud of?
• SRU Biosystems:
o Contributing to the efforts of product from start-up phase to a fully functional and
successful manufacturing facility
o Providing strong leadership of logistics, supply chain, manufacturing
functions, materials, and planning
o Leading lean manufacturing and continuous product improvement initiatives aimed at
reducing cycle times, eliminating redundancies, and increasing throughput, resulting in
a 40% increase in yield and 35% reduction in cycle time
o Leader of technology-transfer for optimized biological surface coatings for
immobilization of proteins, peptides, small molecules and nucleic acids, to
manufacturing operations
• C.S. Draper Lab:
o Developed and demonstrated breakthrough multi-element array technology (8-element
and 64-element) based on existing dual-element array process
o Developed and implemented highly manufacturable silicon-on-insulator fabrication
process for production of chemical sensing arrays
o Created and implemented new, highly effective system for establishing and maintaining
safe operations in a fast-growing, state-of-the-art MEMS laboratory
o Recipient of Draper Recognition Award 1994-2000
12. Example Manufacturing Manager 90-day Plan
Implement & Monitor
Understand & Plan
Observe, Listen & Learn
• Develop an understanding of the • Deliver a clear communication of
territory gaps & needs, including the manufacturing vision/goals
opportunities / needs for and commitment
• Begin to earn the trust, confidence continued skills development • Every action & decision must be
& respect of the team, while • Assess current approach and focused on achieving our
learning and assimilating into the identify opportunities for changes business objectives and improving
company culture and organization in strategy our competitiveness
• Meet and greet members of the • Gain a fact-based understanding • Team focus on solutions to
organization, have one-on-ones of the products and customers’ problems
with team members & other key needs • Motivate & empower the
stakeholders • Prospect and develop new manufacturing team
• Gain a clear perspective of the customers and • Recognize and celebrate success
issues, challenges, opportunities, material/equipment providers ; • Assess progress and update
measures of success & areas for follow up on key opportunities plans accordingly
improvement • Utilize methodical, data-driven
• Begin to build a techniques to identify new
strong, collaborative partnership opportunities, where appropriate
with the organization & customers
• Understand the top 3 challenges
of the organization and discuss
options to meet those challenges
Brenda Hugh
3/9/2012
14. Qualifications Summary
Technology Leadership Management
• 20+ years in R&D and life • Strategic vision / planning • Collaborative team
science industry • Proactive leadership management
• Ability to learn new • Communication skills • Product Quality Management
products/technologies in • Cohesive team building • Resource
complex life science markets • Change agent, driving process management, human & capital
• Understand technology and improvement and operational assets
link to customer needs excellence • Dept.
• Development of processes & • Deployment of common planning, budgets, metrics and
procedures processes, best practices, objectives
• Technology transfers knowledge sharing tools • Customer facing
roles, meeting customer needs
& expectations
• Networking through
colleagues, industry leaders to
identify new processing
20+ years experience leading manufacturing & engineering teams, through a proactive
technologies
and data-driven pursuit of excellence
