Medical Device Manager

Manley Enoch

*** ******** ****, ****** *****, Maryland 21117

Home: 410-***-**** – Cell: 443-***-****: ************@*****.***

Summary: Downstream Protein Purification Manager/Expert

Over 17 years of protein purification experience. Downstream cGMPmanufacturing knowledge with extensive experience in the use of the AKTA systems (the Pilot, the Explorer and the Process) I am familiarized with TFF and Amicon protein concentration and diafiltrationequipment. I am familiar with protein refolding and purification. I have the ability to monitor and analysis targeted protein using methods such as SDS-PAGE, ELISA, IEF, HPLC and pertinent biological and biochemical assays.

Experience:

Advanced Bioscience Laboratories, Rockville, Maryland

October 2009 to July 2012

Protein Purification Specialist

• Wrote and reviewed SOPs, Batch records, Material Specification and documents used in the Contract manufacturing Department.

• Ordered laboratory supplies.

• Ensured all activities meet FDA, OSHA, EPA and DEA requirements.

• Initiated and implemented Corrective Action/Preventive Actions to satisfy GMP process deviations.

• Trained other associates on how to use the AKTA Pilot/Process systems.

• Packed various chromatography columns and qualified them for protein purification.

• Protein Concentration and Diafiltration using the TFF system

• Protein Refolding and purification

• Assisted in the validation and calibration of manufacturing equipment.

• Worked very closely with QC and QA to get manufactured products released.

• Supervised and ensured that buffers are made according to the batch records.

• Controlled endotoxin contamination of manufactured products.

• Monitored pH and conductivity of purified and in-process protein manufactured products.

• Worked as a team player to achieve success.

• Completed manufacturing documents on time and accurately in compliance with cGMP process.

Becton Dickinson and Company, Hunt Valley, Maryland

September 1995 to August 2009

Protein Purification Scientist

• Purified polyclonal and monoclonal antibodies used in medical device manufacturing.

• Used the Amicon Concentration unit to concentrate antibodies

• Dialyzed antibodies with dialyzing tubes.

• Supplied purified antibodies (e.g. Group A Step, RSV, Flu A, Flu B, Neisseria meningitis, Hib, Clostidiumdifficile and others to many departments in the company.

• Column Chromatography experience (Affinity, Size exclusion, Protein A and G) purifications.

• Familiar with all laboratory equipment (Spectrophotometer, IEF system, conductivity and pH meters, Balances SDS-PAGE, HPLC and FPLC systems and others).

• Worked with R&D in the development of new products.

• Wrote and Reviewed SOPs and Batch records.

• Analyzed targeted protein with HPLC and SDS-PAGE.

• Ability to work under pressure and achieve success.

Education:

Catonsville Community College, Baltimore, Maryland. 1994

Courses taken:

Microbiology General Chemistry 1

General Chemistry 1 Lab General Chemistry 2

General Chemistry 2 Lab Organic Chemistry 1

Organic Chemistry 1 Lab General Biology

Statistical Methods

Coppin State University, Baltimore Maryland 1992

Bachelor of Science: Criminal Justice.

Laboratory Skills

• Chromatography Column sanitization

• Packing chromatography columns and determination of theoretical plates.

• SDS-PAGE, IEF, Centrifugation, Calibration and use of laboratory equipment.

• Deviation waiver and Non-conformance writing.

• SOP, SMP, MS writing skills.

• Root Cause and Corrective Action Reports.

• Excellent oral and written skills

• Team Player (work well with others).

Computer Skills

• Microsoft Office

• SAP

• QDMS

• JAMIS

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