Steve B. Cohen
North Miami Beach,USA
Summary
With over 20 years of experience in biopharmaceutical manufacturing, I bring extensive expertise in plasma fractionation, purification, and cGMP-compliant operations, including direct leadership roles at ADMA. I have a proven ability to manage round-the-clock production activities, meet yield and fulfillment targets, and maintain a strong FDA- and cGMP-compliant environment. I am highly skilled in chromatography, TFF, automation systems, and large-scale biologics equipment, with a strong track record of troubleshooting complex processes and ensuring right-first-time execution. I excel in supervising and developing high-performing teams, leading investigations and root-cause analyses, improving operational processes, and supporting organizational planning and production goals—fully aligning with ADMA’s expectations for a Production Operations Manager.
Overview
29
29
years of professional experience
Work History
Supervisor, IgG Manufacturing Purification
Adma Biologics
09.2021 - Current
- Supervise Mfg. Technician and Group Leader positions.
- Oversee the manufacture of IgG plasma intermediates and / or bulk products within cGMP guidelines.
- Review and approve timecards to ensure compliance with attendance policy.
- Provide shift leadership and sound judgement and decision-making regarding quality, processing, capacity, personnel, and any other issues as they arise with appropriate consultation with and notification to management.
- Prepare team and individual work schedules and coordinate assignments to maximize production efficiency while maintaining high quality and documentation standards. Coordinate personnel and resources on a day-to-day basis to accommodate the work schedule.
- Comprehend and understand automation systems (PAS), CIPs, HMIs, etc. and possess mechanical aptitude to troubleshoot the type of problems associated with departmental processes and equipment.
- Assure that the Department Managers, are updated as to the status of the workflow, any problem areas, personnel difficulties, exceptional performance, and any operational information as required by the Manager.
- Comprehend and understand automation systems (PAS), CIPs, HMIs, etc. and possess mechanical aptitude to troubleshoot the type of problems associated with departmental processes and equipment.
Plasma Fractionation Manufacturing Group Lead
Adma Biologics, Inc.
06.2017 - 09.2021
- Oversee the manufacture of pharmaceutical products within CGMP guidelines.
- Maintain a clean and safe working environment.
- Evaluate workload and assign tasks to technicians on a daily basis.
- Prioritize work based on production schedule and meet deadlines.
- Assure that all appropriate logs and batch records are completed accurately and in a timely fashion.
- Troubleshoot work related problems to ensure that delays are avoided.
- Order materials that are needed for production in a timely manner so that adequate supplies are available to avoid production delays.
- Participate in training of employees.
- Ensure process areas are sanitized to meet room specifications
- Perform minor maintenance work on some equipment.
- Perform shift changeover between shifts.
Plasma Fractionation Manufacturing Technician III
Biotest Pharmaceuticals
01.2011 - 01.2017
- Performed fractionation manufacturing operations in an FDA licensed, cGMP controlled, high volume human plasma protein manufacturing plant.
- Actively participated in the training of other technicians.
- Worked as part of a team, operating centrifuge and filtration separation equipment, controlling and monitoring the processes through computerized automation systems.
- Prepared chemicals, buffers, tanks, transfer lines and other equipment used in the plasma manufacturing process.
- Cleaned and sanitized equipment before and after use.
- Followed manufacturing SOPs and completed batch records.
- Performed conductivity and in-process pH measurements and adjustments.
- Ordered, maintained, and dispensed raw material using SAP and recorded information on disbursement sheets.
- Good verbal and written communication skills and able to grasp mechanical, fluid flow and process parameter control concepts.
- Acting Group Leader on the night shift.
- Daily scheduling and task assignments to other Technicians.
- Reviewed Batch Records/documentation during and at the end of the shift.
Process Development and Validation Specialist / Cross-functional training
Biotest Pharmaceuticals
01.2011 - 01.2011
- Coordinated and executed all cleaning validation activities for new Monoclonal Antibody Production facility
- Execute cleaning validation protocols for product manufacturing and support processes.
- Perform testing and sampling for cleaning studies, including rinse water sampling and surface swabs.
- Provide training on SOPs relevant to cleaning validation procedures.
Monoclonal Antibody Purification Manufacturing Technician
Biotest Pharmaceuticals
01.2010 - 01.2011
- Performs / assists / oversees column chromatography procedures
- Performs / assists / oversees Inoculations and in-process cell culture operations
- Performs / assists / oversees Tangential Flow Filtration (TFF)
- Performs / assists / oversees Centrifugation and Depth Filtration for cell culture harvests.
- Evaluates daily workload and assigns tasks to team.
- Ensures adherence to all cGMP and Batch Production Record requirements.
- Troubleshoot technical issues to ensure delays are avoided.
CTM Lead Operator/ Floor Supervisor
Azopharma
01.2008 - 01.2010
- Operated equipment used in the manufacturing of drug product (blending, compression of tablets, coating, liquid, sand granulation)
- Processed drug product following cGMP guideline.
- Assisted in production process improvements.
- Performed maintenance of manufacturing and packaging equipment.
- Assisted in the execution of equipment installation and operation qualifications.
- Contributed to the development of Standard Operation Instructions for new equipment.
- Ensured the continuous operations of packaging/manufacturing processes by providing all required equipment /documentation or trouble shooting on existing process-related problems.
- Performed material and components checks assigned to the batch to ensure that the proper materials and quantities are issued and released.
Lead man
Stubbs painting
01.2006 - 01.2008
- Traveled painting Wal-Mart’s and houses.
- Order paints
- Organize crews
Lead Operator
IVAX Pharmaceuticals
01.1997 - 01.2006
- Worked as an operator in blending, compression, coating, and encapsulation of drug products.
- Performed assign duties following ISO instructions, GMP’s and company SOP’s to complete each processing step properly and safely.
- Inspected and monitored product assuring quality and integrity at all times.
- Responsible for the set up, cleaning, and maintenance of processing equipments.
- Worked with Technical Operations in completing validation runs designed to improve operating performance and to reduce waste and cost.
- Responsible for the maintenance and testing of the suitability standards for the D.I water system.
- Certified forklift operator. Used forklift to push, lift, and stack products in and out of the warehouse.
- Maintained and installed pharmaceutical equipments.
- Maintained accurate records of daily operations
- Responsible for data entry on batch records according to cGMP’s and company SOP’s.
- Monitored production and recorded data from gauges and indicators.
- Worked as an operator in coating, chilsonator, and encapsulation.
Education
High School Diploma - undefined
Miami Edison Senor high
Miami, FL01.1989
Skills
Highly trained in the operation and troubleshooting of the following pharmaceutical machinery
Interests
Fitness, fishing, painting.
Timeline
Supervisor, IgG Manufacturing Purification
Adma Biologics
09.2021 - Current
Plasma Fractionation Manufacturing Group Lead
Adma Biologics, Inc.
06.2017 - 09.2021
Plasma Fractionation Manufacturing Technician III
Biotest Pharmaceuticals
01.2011 - 01.2017
Process Development and Validation Specialist / Cross-functional training
Biotest Pharmaceuticals
01.2011 - 01.2011
Monoclonal Antibody Purification Manufacturing Technician
Biotest Pharmaceuticals
01.2010 - 01.2011
CTM Lead Operator/ Floor Supervisor
Azopharma
01.2008 - 01.2010
Lead man
Stubbs painting
01.2006 - 01.2008
Lead Operator
IVAX Pharmaceuticals
01.1997 - 01.2006
High School Diploma - undefined
Miami Edison Senor high