Steven Sloshberg

Union, NJ *****

908-***-****

adkqj8@r.postjobfree.com

PROFESSIONAL EXPERIENCE

Biotech & Pharma Process & Manufacturing Consultant

Process Development Solutions Architect FDA Approvals Pharma Tech & CGMPsOne of three on Hemoglobin-based Oxygen Carrier SANGUINATE® patent, currently approved in several countries and the United States as of September 2018.

Visionary influencer with broad and comprehensive expertise in biology and related subjects to design, develop, and implement all aspects of biotechnology operations throughout start-up and large-scale cGMP manufacturing facilities.

Persuasive leader with demonstrated expertise directing top-performing, cross-functional teams through research, design, implementation, and support of complex biotechnology applications and infrastructure that included gowning supplies, production, equipment, and developing process changes to ensure a superior and consistent product.

Strategic and tactical entrepreneurial scientist with an established record of incorporating forward-thinking processes into existing frameworks and architectures.

Professional Strengths:

FDA Validation Requirements

Experience with ICH, GCP

Change Management/Flexible

Team Leadership

Resource Management

Risk Management

Sound Problem Resolutions

Effective Communicator

HPLC, ELISA, Isoelectric Focusing, Electrophoresis

SOPs

Batch Records

Prioritize and execute any task in ever changing environment

Solid computer skills with any program such as Office

Detailed communication ability with other departments

BC Forward Contracting-Indianapolis, IN

Contracted to Celgene/BMS, Summit, NJ as a Technical/Compliance Writer, 06/202011/2020

Evaluate deviations and write to CGMP standards.

Write or rewrite SOPs, Work Practices, and other CGMP documents.

Suggest improvements to documents based on many years of experience.

Prolong Pharmaceuticals. South Plainfield, NJ & Monmouth Junction, NJ

Contributed to positioning strategy to grow the company into a fully Commercial entity with a portfolio of hematology and oncology products, multiple active clinical development programs, and large-scale cGMP manufacturing facilities.

Process Development Specialist. 2016 -2019

Transitioned from Director of Process Development to mentor new-hire SME scientist to assume Process Development department.

Recruited and hired three highly qualified personnel tasked with Process Development roles.

Served key role supporting and mentoring personnel to align cross-functional operations and drive a cohesive, unified approach to operations and growth.

Ensured organization-wide adherence to fully defined Design Space for current product while maintaining cGMP across all aspects of work.

Wrote CGMP documents such as revised batch records, SOPs, and CMC section for FDA submission. The CMC section included items such as the theory behind the work, the reasons for performing process steps as they were done. Also included the equipment utilized, the reasoning behind the equipment used, and results obtained from the processing such as analytical results and their meaning. Attributes of the final product were established based on analytical results as well as in-process testing and results.

Director, Process Development. 2014 - 2016

Recognized for expertise, commitment, and bottom-line results with additional role as Director of Manufacturing to facilitate continuity of process during relocation to larger clinical space.

Positioned as the SME for then-current product and processes, accountable to ensure process was reproducible and consistent with the process at smaller scale for expanded manufacturing opportunity.

Successfully led team and operations through development processes to drive company into Phase II and Phase III clinical production stage.

Designed and executed effective, well-thought-out and prepared Design of Experiments (DoE) that improved definition of Design Space.

Optimized defining Design Space by encompassing Critical Quality Attributes as per ICH Q8-Q11.

Responsible for all CGMP documents and revise as necessary, including SOPs, batch records, including SOPs for all equipment utilized during Manufacturing.

This time was also used to think ahead to writing the CMC section for the FDA submission and bringing documents used as well as analytical results together to fully understand the process and explain the significance of results as well as the product attributes.

Director, Manufacturing. 2010 - 2014

Leveraged broad and extensive hands-on experience in Aseptic Processing Area to drive clinical manufacturing operations.

Led and directed a team between three and six personnel through manufacturing process of novel product designed for early phase clinical trials.

Successfully directed clinical trials with the result of accelerating product toward late clinical phase trials.

Contributed to selecting equipment for scale-up of processes and for early phases of design of larger clinical manufacturing space.

Transitioned to Director of Process Development to allow onboarding of single-use equipment expert, Director of Manufacturing.

Ensured that the CMC preparation was in place. This was done by writing batch records and SOPs so that the information would translate easily into a CMC section for FDA submission.

Manager, Production. 2005 - 2010

Launched and grew initial production of early start-up product, directing all phases of work from systems design to lab/production work.

Combined experience and ongoing research to develop early cGMP documentation impacting batch records and SOPs to drive product to animal testing in less than two years.

Strategized approach that resulted in allowing product testing in animal studies within nine months of hire.

Accountable for small clean room, documentation, choosing equipment, and actual production work while supervising and training assistant.

Protected stakeholder interests by maintaining NIH grants, ensuring compliance with technical updates and budget needs as required.

SKILLS AND PROFESSIONAL DEVLOPMENT

Manager, Support Services for Manufacturing Imclone Systems, Inc. Somerville, NJ

Supervisor, Commercial Purification Imclone Systems, Inc. Somerville, NJ

Production Manager Enzon, Inc. Piscataway, NJ

Supervisor, Clinical Production Enzon, Inc. Piscataway, NJ

Research Associate III Enzon, Inc. Piscataway, NJ

Research Scientist FMC Bio Support Materials. Pine Brook, NJ

Professional Development

Help Desk Analyst Program Cittone Institute. Edison, NJ (GPA: 4.00/4.00)

COBOL/ MVS JCL languages Chubb Institute for Computers. Jersey City, NJ

Professional Affiliations

International Society of Pharmaceutical Engineers (ISPE).

Parenteral Drug Association (PDA).

Technology Competencies:

Help Desk Functions & Malfunctions COBOL/MVS JCL Networking & IP Management as well as EXCEL, ACCESS, WORD and SharePoint usage at expert level. Included is use of Veeva for CGMP document approvals.

EDUCATION AND CERTIFICATIONS

Education & Professional Development

Degree in Medical Technology Vanderbilt University. Nashville, TN

ASP License #143551

Graduate Studies in Immunology (no degree) Seton Hall University. South Orange, NJ

Bachelor of Science (B.S.), Biology, Chemistry Minor Seton Hall University. South Orange, NJ

Cum Laude (GPA: 3.50/4.00)

Attended classes and graduated from programs concerning computer skills, including COBOL, JCL, and Help Desk skills. Extensive exposure to DOS.

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