C LY D E R . M C C L E L L A N D

*** ***** ******** #* *****: 650-***-****

San Mateo, CA 94401 Email: acf8vj@r.postjobfree.com

B I O T E C H N O L O G Y /P H A R M A C E U T I C A L L E A D E R

Versatile Production Supervisor with demonstrated expertise managing staff, 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 Staff Training/Management Program Oversight

Overhead Reduction Safety/Regulatory Compliance Schedule/SOP Development

Operations Leadership Technical Support 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

2014

YOH/BAYER

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.

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.

2012-2013

ALEXZA PHARMACEUTICALS

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.

Clyde R. McLelland Resume, Page 2

2012

INTERSECT ENT

Production Supervisor

Led team of 18 direct reports and managed schedules for upcoming production runs.

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.

2008-2010

BAXTER PHARMACEUTICALS

Production Supervisor

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.

2005-2007

NEKTAR THERAPEUTICS

Production Supervisor

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 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.

2003-2005

ALZA/JOHNSON & JOHNSON

Production Supervisor

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

Bachelor of Arts, Business Administration, Phoenix University, San Mateo, CA, Anticipated 2015

Certification, Supervisor and Management, Pathwise CAPA Training

Professional Development, Six Sigma/Lean, 5S, HAZMAT, CAPA, TPM, cGMP, and ISO

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