Manufacturing Supervisor

kPROFESSIONAL SUMMARY

Successful Clinical Manufacturing Supervisor with eighteen years of

experience in a highly regulated Biotechnology industry providing strong

leadership in clinical manufacturing including Cell Culture, Media Buffer

and Bioservices. Key contributor and subject matter expert of various multi-

disciplinary teams responsible to manufacture drug product from clinical

trials to market. Extensive manufacturing knowledge in various aspects of

cGMP including, FDA regulations, technical writing, SAP and Trackwise.

Planned daily operations, staff schedules, production schedules and

meetings with stakeholders (QA, QA, PD, Validation and Planning)

successfully bringing 28 new drug products from Process Development through

Phase 1 clinical trials.

Additional Strengths & Competencies:

FDA Regulations Clinical Manufacturing Scheduling

Inventory Control Writing NCEs/Deviations Strong Leadership Skills

cGMP Compliance Housekeeping Trackwise and SAP

Author/Review SOP's Aseptic Techniques Applications

cGMP Document process

CAREER HISTORY

Laureate Biopharmaceutical Services (Contract Manufacturing Organization)

(12/2012 to Present)

< Senior Staff Scientist/Supervisor (Upstream Manufacturing)

Responsibilities:

. Provide direct supervision of upstream personnel in the cell culture

pilot plant and clinical manufacturing facility. Schedules production

campaigns in multiple sizes of ABEC stir tank bioreactors ranged from

75L to 2500L, 250L and 1000L Hyclone single use Bioreactors, and Wave

Bag Bioreactors ranged from 10L through 1000L

. Set and update the daily schedule for manufacturing work by

coordinating with Project Management.

. Interacting with clients for the planning and execution of cell

culture runs which includes writing master batch records,

specifications, and all other ancillary documentation to assure

customer requirements are attained.

. Creating Bill of Materials for each client specific campaigns and

ensuring materials are on hand for the start of production.

ImClone Systems, Inc. (A Wholly Owned Subsidiary of Eli Lilly Corporation)

(09/2002 to 12/2011)

< Supervisor, Media/Buffer and Cell Culture, Clinical Manufacturing

(9/10 to 12/11)

< Clinical Manufacturing Supervisor, Bioservices (01/05 to 09/10)

< Interim Supervisor/Senior Operator (05/04 to 12/04)

< Operator III (09/02 to 05/04)

Responsibilities:

. Supervise up to 12 direct reports in the media buffer (supplying media

to purification and media to cell culture) and in cell culture

producing mammalian cell culture runs. Responsible for Mid-year, year-

end reviews, all hiring and referrals for terminations. `

. Supervise daily operation to meet all production goals (process

planning, work schedules and all interactions between internal and

external departments).

CAREER HISTORY

. Interact with other departments (QC, QA, Process Development,

Validation, Logistics, Facilities, Purchasing, etc.) for planning

processes to bring new drug product/product development through

Clinical Manufacturing.

. Manage contracted cleaning company: to comply with all ImClone

policies and to ensure that the Clinical Manufacturing Suite was

cleaned on a daily basis as well as on an emergency basis.

Achievements:

. Implemented a reduced changeover between drug product(s) - allowed a

three-week gain in the production schedule per campaign and saved $34K

from each changeover between drug campaigns.

. Managed schedules to limit overtime. Thoroughly investigated the

gowning supplies, determined the department was overstocked, worked

with vendor, and reduced supplies for a saving of $29K per year.

Chiragene (Celgene), (A Wholly Owned Subsidiary of Cambrex Corporation)

(03/94 to 12/02)

< Research Assistant (04/00 to 09/02)

< Senior Laboratory Technician (04/96 to 12/00)

< Laboratory Technician II (03/45 to 04/96)

Responsibilities:

. Ran and analyzed daily fermentations in New Brunswick, LH, and Chemap

style fermentors for the production of biocatalysts.

. Performed all aspects of daily fermentation including inoculums

preparations, routine and experimental runs, harvesting techniques,

analyzing productivity and documentation/reporting.

. Performed customized experiments and analysis for enzyme production.

Achievements:

. Designed and modified fermentation systems to optimize biocatalyst for

growth and scale up. This included D.O. and pH modifications,

customizing media and substrate additions, and sampling inoculating

strategies. Coordinated Toll Manufacturer's biocatalyst runs with

various sizes ranging from 3000L to 18000L.

. Trained in Hazardous Waste Management to comply with various state

agencies to handle the site's wastes needs.

EDUCATION/PROFESSIONAL DEVELOPMENT

Vocational Degree

Piedmont Technical College, Roxboro, NC

Biotechnology Certificate Course

Raritan Valley Community College, Branchburg, NJ

Computer Entry, Windows, Business Administration Business Management

Raritan Valley Community College

Fundamentals of High Performance Liquid Chromatography

Hazardous/Toxic Waste Management (Lyons Technology)

Materials Transportation (Lyons Technology)

Fermentation Methods and Scale-up Course - Penn State

Leadership Development Initiative - Dale Carnegie

Certified Pharmaceutical GMP Course - American Society of Quality

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