Production Management, Project Management, Continuous Improvement, Pr

Qualification Highlights

Extensive experience in technical production and operational leadership, project management and continuous improvement, organizational, team and employee development, and P&L management. History of developing positive working relationships, collaborative cross-functional teams, and outstanding client services. Experienced in facilitating change within a diverse workforce to meet operational, financial and quality objectives. Ability to align departmental infrastructure, functionality and performance with corporate goals.

Core Competencies

Production Management

Provided production management and operational leadership to manufacturing departments in the biotechnology, semiconductor and cosmetic industries. Managed the scheduling, staffing, training, quality standards, issue resolution, continuous improvement and supply chain operations for large and small production units.

P&L Responsibility

Directed small business units, large corporate departments and entire businesses in daily operations, structure optimization, system enhancement, resource allocation, and employee success, ensuring net profits aligned with department and corporate goals.

Process Development, Project Management and Continuous Improvement

Provided project management, portfolio management and continuous improvement expertise to production and business systems within the world’s largest biopharmaceutical manufacturing facility.

Employee Development and Coaching

Led, coached, evaluated and rewarded team members to accomplish shared goals, within an environment of open-mindedness, diversity, flexibility and transparency. Participated in the development, testing and rollout of numerous management and developmental processes within large and small corporations.

Corporate Culture Development, Promotion and Maintenance

Within large corporations, small businesses and functional departments, developed a culture which embraced established values, and supported the vision and mission of the organization.

Customer and Client Service

Collaborated with clients, business partners, executives and government agencies to meet customer needs and expectations. Focused on both internal and external customers, at all levels, to develop mutually beneficial, collaborative partnerships.

Professional Experience

Face Reality, Inc. Business Operations Director 2015 - 2017

Responsible for P&L management of local clinic and national wholesale operation, including warehousing, order processing and distribution operations.

Restructured and directed management team to organize and streamline operations, enhance communications and achieve corporate goals.

Increased number of wholesale clients by more than 80% over a 15 month period.

Managed the operation and maintenance of all facilities and equipment, including expansions, upgrades and compliance enhancements.

In preparation for expected wholesale growth, increased functionality of business systems, including IT functionality and security, communication platforms, and merchant services compliance.

Your Body Works, Owner 2008 – 2015

Designed, constructed and operated two professional health education and fitness training centers.

Business served 350+ members in personal training, nutritional counseling and multi-sport conditioning.

Responsible for P&L management: marketing, finances, business applications and general daily operations.

Success of business drove expansion in 2012, which doubled square footage and operational services, including CrossFit training.

Genentech, Inc, Director, Project Management and Operational Excellence 2002 – 2008 Hired and managed senior staff providing Project Management, Portfolio Management and Continuous Improvement expertise to production and business systems within the worlds largest Biopharmaceutical manufacturing facility.

Directed Project Managers controlling the scope, timeline and budget of a $10,000,000 annual project portfolio.

Introduced formal Portfolio Management methodologies to enable senior executives to prioritize and complete key initiatives aligned with the site’s strategic plan.

Developed and chaired monthly senior leader forum reviewing key metrics and initiatives impacting the site’s operational performance and mid-range plan.

Implemented Operational Excellence methodologies (Lean, DMAIC, Kepner-Tregoe, 5S, etc.) to drive continuous improvement to the site’s manufacturing and business systems.

Provided Corporate and Public Relations expertise for key media events and visitors. Services included developing and delivering corporate presentations, conducting tours and interfacing with media contacts visiting the site.

Served on local political, educational and economic development boards, providing Genentech’s perspective and support to City and County initiatives.

Genentech, Inc, Sr. Manager, Operations Logistics 1997 – 2002 Formed and managed multi-disciplined organization providing critical support functions to a 400,000 sq. ft. highly automated, multi-product biopharmaceutical manufacturing facility. Functional support included Production Planning and Scheduling (GRIP, AS, BPCS), Business System Support (POMS), Technical Training, Technical Writing, and GMP Production Support (quality metrics, corrective action implementation and technical interfacing).

Startup Team Lead for Final Purification and Freeze/Thaw operations during facility construction, debug, validation and facility commissioning leading to FDA licensure.

During construction and startup of new facility, assumed leadership for Engineering’s daily startup coordination meeting, and transitioned forum into daily production meeting to support GMP operations.

Led Senior Management Team aligning resources and prioritizing key activities associated with the facility’s ability to make, assess and release final product.

Developed and implemented tracking methodologies for key quality metrics related to site-wide GMP operations, the implementation of corrective actions to address system deviations, and compliance with established Quality and Regulatory parameters.

Established and led Materials Usage Team focusing on systems to track material usage, reducing waste, and providing accurate inventory levels for improved planning and budget forecasting.

Functioned as the site’s primary liaison to external visitors, including business partners, political VIP’s, academia, and media events.

Genentech, Inc, Manager, Clinical Filling 1995 – 1997 Managed a multi-shift operation responsible for the aseptic filling of parenterals for clinical applications. Assured compliance with all FDA and Regulatory process control procedures, SOP’s and cGMP’s

Managed filling, maintenance and validation activities ensuring adequate supply of over 10 products for clinical applications and trials.

Coordinated the validation, startup and utilization of new processing equipment to increase Clinical Filling’s capacity during peak production demands.

Restructured Clinical Filling’s staffing and support groups to align their core business with department and corporate goals.

Led cross-functional team to reduce duration of annual shutdowns, while increasing the functionality and cGMP compliance of the facility following key maintenance and construction activities.

Member of Genentech’s Aseptic Processing Task Force chartered to recommend and implement policy to improve aseptic technique within Pharmaceutical Manufacturing operations.

Genentech, Inc, Manager, Marketed Packaging and Inspection 1986 – 1995 Managed all operations related to packaging, empty vial and final vial inspection operations for Genentech’s marketed products. Served as primary contact for all Regulatory audits relative to packaging and inspection operations. Managed operating and capital budged exceeding $5.5M.

Successfully managed the packaging launch of five products for US and Canadian markets.

Coordinated the design, construction, licensure and startup of a 20,000 sq. ft. packaging facility.

Directed projects involving the design, testing and operation of packaging automation valued at over $2M.

Authored the packaging and inspection sections of Regulatory submissions associated with new product applications and revisions.

Developed and maintained a comprehensive cGMP training program for Inspection and Packaging Technicians.

Fund Raising and Event Coordination Experience

American Diabetes Association, Volunteer 2001 - 2015

2001 Napa Tour de Cure Committee Member

2002 – 2011 Nine year Napa Tour de Cure Chair

2005 – 2006 San Francisco Bay Area Community Leadership Board Member

2005 – 2011 Presenter/Trainer at annual volunteer leadership conference breakout sessions

2008 – 2009 Presenter/Trainer for annual ADA Staff Training

2008 – 2015 National Volunteer and Mentor, Tour de Cure

2012 – 2015 National Income Development Committee Member

Increased event revenue from $350,000 to $1,820,000 during tenure as Napa Tour de Cure Chair.

Mentored Tour de Cure Committees in fourteen key markets, each increasing total funds raised.

Diabetic Youth Foundation

2002 – 2003 Board of Directors

2003 Annual Fund Raising Gala Chair

Education

Northern Illinois University

BS, Developmental Physiological Psychology

Minor, Applied Probability and Statistics

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