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CLYDE R. MCCLELLAND
1435 Liebold Phone: 650.670.7679
Detroit MI 48217 Email: randy_mcclelland@yahoo.com
BIOT E C HNOLOG Y/PHARM AC E UT IC AL LE AD E R
Versatile Production Supervisor with demonstrated expertise managing staff, reviews, programs, and
processes within the biotechnology and pharmaceutical industries. Committed to ensuring timely delivery
of diverse products that uphold the brand integrity of industry leading organizations. Skilled trainer and
team builder capable of working with people at all levels. Experienced developing protocols, training
materials, and BPRs. Comprehensive training in HAZMAT procedures and regulations, as well as ensuring
personnel compliance. Proven track records of identifying problems and root causes and implementing
changes to increase productivity and decrease costs.
AREAS OF EXPERTISE
 Process Improvements
 Overhead Reduction
 Operations Leadership
 Staff Training/Management
 Safety/Regulatory Compliance
 Technical Support
 Program Oversight
 Schedule/SOP Development
 CAPA/NCRM Investigations
CAREER HIGHLIGHTS/ACHIEVEMENTS
 Implemented process improvements for mixing area cleaning pumps, resulting in more than $400 cost
savings on each of 10+ mixes done each week.
 Developed and launched protocol to expand operation process parameters, resulting in a reduction of
scrap material.
 Reduced waste steam expenses by 30%.
 Designed and wrote BPRs as Lead Supervisor of OCIP program, ensuring timely installation of critical
equipment and adherence to project deadlines.
 Streamlined batch record process, improving step performance times by 50%.
 Created new balance procedures, designed to minimize equipment damage and extend lifespan.
 Ran 14 lots with no exceptions during production.
 Recipient of Innovation and Teamwork Awards.
PROFESSIONAL EXPERIENCE
VENITI FREMONT CA FEB 2015
Senior Manufacturing Supervisor
 Led team of 8 direct reports and managed schedules for upcoming production runs.
 Supervised Production and Packaging operations in CER.
 Created and facilitated training programs for team.
 Performed LHR records reviews, as well as CAPA and NCRM investigations.
 Supervise the Material department. Purchase supplies for production.
 Supervise shipping.
YOH/BAYER BERKELEY CA CONTRACT SEP 2014-Oct 2014
MANUFACTURING EXPERT
 Developed and executed commissioning and qualification and protocols, including IQ, OQ, and PQ, as
well as related reports in compliance with company objectives and cGMP requirements.
 Provided hands-on technical support and facilitated project team meetings to review goals and
timelines.

Clyde R. McClelland Resume, Page 2
 Managed operations to ensure compliance with schedule and budget or project.
 Oversaw all vendor C&Q activities and ensured effective client relationships.
 Directed development of User Requirement Specifications for clean and dirty instruments and utilities.
ALEXZA PHARMACEUTICALS MOUNTAIN VIEW CA CONTRACT AUG 2012-Oct 2013
MANUFACTURING TECH III
 Wrote batch records, SOPs, and MOPs in support of commercial and clinical production activities.
 Performed CAPAs and PMs on equipment and developed NCMRs.
 Managed online troubleshooting and maintenance for filling and packaging equipment.
INTERSECT ENT PALO ALTO CA CONTRACT MAR-JUN 2012
PRODUCTION SUPERVISOR
 Led team of 18 direct reports and managed schedules for upcoming production runs.
 Supervised Production and Packaging operations
 Coordinated and facilitated training programs for team.
 Performed protocol and LHR records reviews, as well as CAPA and NCRM investigations.
 Implemented changes to ensure operations were aligned with regulations and procedures.
BAXTER PHARMACEUTICALS LOS ANGELES CA APR 2008-Oct 2010
 Managed filling and production area operations, including the supervision of 14 direct reports.
 Coordinated Kaizens for filling and production team and directed aseptic filling area team as needed.
 Responsible for scheduling and maintaining CIP/SIP systems for sterile filtration area.
 Performed protocol and batch record reviews and CAPA investigations, implementing needed changes.
NEKTAR THERAPEUTICS SAN CARLOS CA APR 2005-Oct 2007
 Oversaw clinical filling area, including the management of 12 direct reports, scheduling of upcoming
production runs, and document revision based on project team-specified parameters.
 Coordinated communications and operations between project teams and manufacturing groups to
support production/packaging and ensure timely delivery of results.
 Collaborated with project teams on the integration of process and equipment changes.
 Wrote support protocols for scale-up activities and performed protocol and batch record reviews.
ALZA/JOHNSON & JOHNSON REDWOOD CITY CA FEB 2003-Apr 2005
 Managed 32-member Mixing, Coating, and Packaging group during second shift.
 Responsible for recruiting, interviewing, hiring, and training team members.
 Collaborated with company engineers on Six Sigma projects.
 Installed engineering controls and upgraded alarm systems to reduce scrap material.
 Recommended and implemented process improvements for operations to save costs.
 Conducted cleaning validation study and presented findings as part of FDA audit.
EDUCATION & TRAINING
BachelorofArts,Business Administration, Phoenix University,San Mateo, CA, Anticipated 2016
Certification,Supervisor and Management, Pathwise CAPA Training and Greenbelt Six Sigma
CER
Professional Development,SixSigma/Lean, 5S, HAZMAT, CAPA, TPM,cGMP,and ISO

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