1. Mark S. Wholley
15 Lily Pond Road
Somersworth, NH 03878
(603) 692-3230
markwholley@myfairpoint.net
RELEVANT EXPERIENCE:
Shire Human Genetic Therapies, Lexington, MA
Central Services Supervisor, 02/10 to Present
• Direct involvement with Shire’s ATLAS plant startup.
• Organization and planning of manufacturing operations for the production of clinical and commercial products
• Supervision of daily operations for 8 individuals in manufacturing central services department.
Lonza Biologics Inc., Portsmouth, NH
Planning, Procurement, Logistics Sr. Logistics Supervisor, 06/04 to 11/09
• Supervision of daily operations for 17 individuals within the logistics department, with responsibility for shipping,
receiving, warehousing, inventory control, raw material sampling and all transportation functions.
• Responsible for over $30 million dollars worth of raw material inventory and $60 million dollars of final product.
• Directed the increase of 300 additional pallet positions (50% increase) to the existing warehouse footprint by
decreasing aisle width, utilizing high density racking and installing a new state of the art “Compact Storage
System”.
• Instituted receiving hours to insure 24 hour timely receipt of all materials.
• Developed a more robust Cycle Count Program (99.8% accurate), to insure 4 complete cycles per year of the entire
warehouse.
• Directed the implementation of a new “transfer method” for materials entering manufacturing to exceed FDA
guidelines.
• Implemented new bar-code scanners and bar-code labels to streamline operations and increase accuracy.
• Implemented Operational Excellence initiatives utilizing methodologies such as 5S, Kaizen Events, Hoshin
Planning Six Sigma and Visual Management.
• Instituted cross training initiatives for all Logistics personnel. Successfully trained the entire team in all facets of
Logistics’ operations allowing more efficient staffing levels.
• Established a Freight Routing Guide which was issued to all vendors to control the number of freight carriers,
reduce freight charges and streamline inbound freight.
• Participated in the design, construction and set-up of warehouses in Singapore, England, Spain and France.
• Portsmouth warehouse was identified as “best warehouse” within all of Lonza and “best practices” were identified
and introduced to all Lonza warehouses.
• Presented and successfully passed all area audits conducted by Lonza customers, the FDA and other foreign
regulatory agencies.
• Selected by Site Leadership to serve as the Facilitator to deliver company wide training on the TOPF Safety
Training Program.
• Member/Leader of numerous safety teams which include HazMat response, First Aid Responder, Ergonomics &
material handling, Logistics Safety Team and Corporate Health & Safety Team.
• Primary point of contact for Logistics for the remediation of quality excursions in batch records and material
dispensing sheets using the TrackWise Quality Management System.
• Authored and updated standard operating procedures and material specifications.
• Primary contact for area crisis management.
• NH Certified fork truck trainer, One of three individuals qualified to deliver training and license approval at the
Portsmouth plant.

2. LONZA Biologics Inc., Portsmouth, NH
Clinical Manufacturing Sr. Process Operator / Purification Supervisor, 06/98 to 06/04
• Operation and maintenance of large-scale chromatography and ultra filtration systems in a multi-product suite.
• Production of clinical grade material under cGMP guidelines.
• Assisted the Process Development Group to optimize production processes.
• Coordinated the daily activities for 10 operators in a multi-lab operation (Fermentation, Purification, Media
Preparation and Buffer Preparation).
• Authored and updated Standard Operating Procedures and Batch Production Records.
• Data collection for process monitoring and metrics.
• Responsible for process and staff scheduling requirements for suite activities during manufacturing campaigns.
• Provided operator training in accordance with the company program.
• Presented and successfully passed all inspections conducted by Lonza customers, the FDA and other foreign
government agencies.
• Conducted tours for existing customers, potential customers, foreign and domestic regulatory agencies.
• Promoted to Manufacturing Supervisor in May 1999.
Hybridon Inc., Cambridge / Milford, MA
Custom Synthesis Group. Process Development Associate I, 04/96 to 08/97
• Purification and optimization of synthetic oligonucleotides in gram and multigram quantities.
• Maintenance and operation of small scale laboratory equipment using multiple purification techniques (HIC,
DEAE, RP, Ultrafiltration and Diafiltration).
• Maintained a clear and concise laboratory notebook and required records.
• Routine analysis of oligonucleotides by HPLC and Capillary Electrophoresis.
SERONO Laboratories, Inc., Randolph, MA
Operations/Technical Support Sr. Process Operator, 10/94 to 04/96
• Manufacture of clinical supply material under cGMPs.
• Operation, monitoring, and maintenance of large-scale chromatography, Ultrafiltration and Diafiltration systems.
• Worked interactively with the Process Development Group to optimize production processes.
• Development and start-up of purification systems and related quality systems.
• Installation, Operation, and Performance Qualifications.
• Authoring standard operating procedures, and manufacturing production Records.
• Performed analytical process testing.
Repligen Corporation, Cambridge, MA
Clinical Manufacturing Manufacturing Associate I/II, 7/91 to 10/94
• Operation of large-scale protein purification systems.
• Involved in all aspects of system design, selection, purchase, installation, calibration, operation, and maintenance.
• Coordinated department program for preventative maintenance.
• Performed limited analytical testing including BCA and SDS-PAGE.
• Preparation and review of required cGMP documentation including Standard Operating Procedures, Master Batch
Production Records, and training records.
• Promoted to Manufacturing Associate II in March, 1994.
Genetics Institute, Inc., Cambridge/Andover, MA
Clinical Manufacturing Process Operator Trainee / I, 8/88 to 11/90
• Production of recombinant glycoproteins using purification techniques including ion exchange, immuno-affinity,
affinity, size exclusion, and hydrophobic interaction chromatography.
• Assisted in the assessment, design, and installation of new purification systems.
• Prepared Standard Operating Procedures and logbooks for equipment use, facility sanitation, and filter testing.
• Development of raw material and sample tracking during the start-up of the Andover facility.
• Assisted in the execution of validation protocols for new equipment during facility start-up.
• Worked interactively with the Metrology and Validation departments to ensure cGMP compliance during start-up.
• Promoted to Process Operator in August, 1989.

3. EDUCATION:
• Methuen High School, Methuen MA.
♦ General studies. Diploma ~1987.
• Hazmat Team Inc, Hudson, NH / Triumverate Environmental, Lowell, MA
♦ OSHA certified 40 hour hazardous waste operations and safety certificate [Hazwoper]. 1995-2009
• Boulden Management consultants, Rugby UK.
♦ Effective Team Leadership. Certificate~2009
• New Hampshire Technical Community College, Portsmouth NH.
♦ Leadership Development. Certificate~2007
• D. Gallant Management Associates, Portland, ME
♦ Supervisory skills training series ~ 2001
• American Management Association, Boston MA
♦ 1 day course: Supervising people. 1999
ADDITIONAL SKILLS:
• Proficient with Mac and PC applications including
♦ Word
♦ Wordperfect
♦ Excel
♦ PowerPoint.
♦ Visio
• Knowledgeable in Beckman and Pharmacia [UNICORN] software.
• Proficient in the use of
♦ SAP.
♦ Electronic document management systems (DMS)
♦ Quality management systems (Trackwise).
♦ Risk and assessment management systems (RAMS).
♦ Distribution Control Systems (DCS) including Delta V
• CPR and First Aid certified.
• Fork truck license
• (NH) State certified fork truck trainer.