A Pharmaceutical/Biotech consultant with 28 years of broad experience in development through commercial activities. Specialty in GxP manufacturing and operations. Expert in quality systems and regulatory affairs. 

• 28 years of experience in biotech and Pharma

• Expert in manufacturing and analytical development/validation for biologics and pharma 

• Authored regulatory submissions (IND,IDE, NDA, 501k, BLA, Fast Track, Orphan Drug, etc.)

Summary/Highlights

• Managed all technical operations for a biotech company including contracts negotiation and subcontractor management (>30 contractors and consultants). 

• Developed/validated >50 analytical methods in conformance with FDA guidelines, including ELISA, flow cytometry, PCR, endotoxin and many other method types.

• Served as primary QA/QC contact in multiple FDA/EMA/PDMA inspections (pre-approval, routine, compliance).

• Sourced and audited CMOs in the US and worldwide for biologics manufacturing and analytical development. Extensive network of relationships with different companies. 

• Developed and validated bioanalytical methods for GLP use in support of IND-enabling studies and human clinical trials. 

• Authored regulatory submissions (IND, IDE, NDA, 501k, BLA, Fast Track, Orphan Drug, etc.) for antibodies, pharma, device and cell therapy products. 

• Managed many GLP studies, including establishing IND-enabling pharm/tox studies, as well as efficacy studies. Expert in cost-effective vendor management for GLP studies. 

• Validated multiple biologic (monoclonal antibody and others) manufacturing processes in support of BLA submissions.  

• Performed compliance (483, Warning Letter) assessments and remediation

• Established GMP  manufacturing/quality systems for numerous companies, including SOPs, BPRs, lot release specifications and analytical methods.

• Prepared SOPs and other documents for many pharmaceutical and biotech products.  

• Strong knowledge of GXP compliance as well as USP, EP, ICH and FDA guidelines

Professional Experience Highlights (Harmony Consulting)

President, Harmony Consulting, Inc: 2011 – present 
Major Consulting Projects 

Cell Therapy Project Manufacturing/Regulatory Affairs Management | 2016-present
Managed relationship with contract manufacturing organization (CMO) for manufacturing and analytical development/testing of multiple cell therapy biologic products in early clinical development. Sourced and managed other CMOs as required. Created quality system “from scratch” writing >50 batch records, specifications, and SOPs. Authored and submitted 2 INDs and other associated submissions. Regulatory point of contact for FDA.

Biologic Product Project Management | 2015-present
Served as primary contractor for Israeli company preparing Technical/Business proposals for BARDA contract for biologic product, leading to >$100M contract award in September 2015. Currently providing ongoing project management support, including technical support (analytical development) and FDA submissions.

Monoclonal Antibody Validation 2015
Prepared validation studies for a monoclonal antibody product in Phase 3 including writing development reports, gap analysis of manufacturing and testing procedures against current GMP/FDA requirements, writing of antibody manufacturing batch records, and writing validation protocols. 

Medical Device Project Management – 2015-present
Project management for a  >$40M BARDA contract.

Operations Management  (VP Operations) | 2011-2017
Responsible for all GxP operations in a virtual company environment as VP Operations for a pharmaceutical company manufacturing medical countermeasures and oncology products.  Created a GxP quality system “from scratch”, writing >100 SOPs. Responsible for vendor management, with over 10 CMO/CRO’s and over 20 consultants. Regulatory point of contact for FDA.

Remediation Project: Medical Device Company | 2014-2016
Responsible for technical writing, auditing, and general document creation for device company with multiple FDA Warning Letters to remediate their quality and operational systems. 

Other Project Summaries:  2011-2018

From 2011, acted as head of Quality for 4 different companies as a consultant, implementing QA program. Transferred QA to in-house personnel when systems were active. Provided general Quality consulting for many different companies.

Built quality systems for companies manufacturing:

• Sterile parenteral products (biologics and small molecule),

• Cell therapy products, and 

• Drug/device combination products.

• Responsible for all QA functions for GxP operations, including lot release, audits, change control, deviation management, validation, etc.

• Assisted with FDA submissions (pre-IND, IND, EOP2, etc.)

• Managed commissioning, qualification, and validation for pharmaceutical equipment.

• Managed computer system qualification and validation.

• Prepared grant applications for: NIH, DOD, DARPA, NAIAD, and other federal agencies for companies worldwide.

Professional Experience (Other)

Dendreon Corporation, Sr. Manager, Quality Control, 2010-2011

Managed daily QC operations for a commercial active immunotherapy company. 

•   Successfully managed QC start-up of a new commercial AIT facility

•   Conducted technology transfer (TT) of Quality Control methods; assisted in TT of manufacturing processes.

•   Led activities for new staff, including EDMS and LIMS implementations for new site

•   Oversaw QC activities for analytical method, lab equipment, and manufacturing process validation

Spectrum Pharmaceuticals, Sr. Manager, Global Quality Control / Quality Assurance, 2008-2010

Responsible for worldwide QA/QC & Validation for a global commercial biotechnology company with 2 commercial and 8 clinical products. 

•   Established QA/QC systems for the company, including lot release, vendor qualification analytical method validation, equipment validation, and process validation.

•   Led team that acquired and transferred a radiolabeled monoclonal antibody to the company. Sourced contract manufacturers for antibody production.

•   Saved company $2M yearly through alternate supplier qualification.

Biogen IDEC, Manager, Equipment and Process Validation, 2003-2004

Responsible for equipment, utility and process validation for a new $300M biotech production facility in Oceanside, CA. 

•   Was a member of the facility design team from initial stages to finalization of design.

•   Worked with contractors to establish Validation Master Plan (VMP), and validation procedures (IQ/OQ/PQ/FAT/CQ).

•   Established lab equipment validation plan for new facility 

•   Established specifications for new equipment and utilities

•   Interviewed and hired multiple validation contracting firms.

Biogen IDEC, Manager, QC Analytical Methods Validation 1999-2003

Responsible for the validation of analytical methods for the company. Promoted 2003.

•   Managed the validation of over 25 different analytical methods, including bioassays, HPLC, ELISA, q-PCR, micro and others.

•   Transferred analytical methods from R&D to Quality Control in tech transfer (TT) project,

•   Validated laboratory equipment for all QC labs (IQ/OQ/PQ).

•   Created and implemented 21 CFR Part 11 computer validation program

Medeva Pharmaceuticals, Manager QC/Validation, 1998-1999

Responsible for validation (equipment, process, cleaning, computer) for an oral solid-dosage company. 

•   Developed and executed a Validation Master Plan (VMP).

•   Commissioned and validated new manufacturing equipment, computers and utilities (CQ/IQ/OQ/PQ).  Validated existing equipment and utilities.

•   Validated four manufacturing processes (PQ), according to FDA guidelines and using Statistical Process Control (SPC) techniques.

•   Led QA/QC/Validation technology transfer (TT) process of all products to new facility. 

•   Served as QC Manager as part of company remediation. Responsible for all OOS investigations and product release.

•   Supervised a staff of 20 plus contract groups.

Peregrine Pharmaceuticals, Director, QA Validation / Project Manager, 1997-1998

Supervised the design of a $30MM GMP pilot plant facility for a monoclonal antibody. Supervised a staff of 6 plus contractors. 

•   Managed technology transfer (TT) and scale-up of monoclonal antibody product.

•   Established a VMP and commissioning and validation schedule (CQ/IQ/OQ/PQ execution).

•   Coordinated the activities for the submission of an IND

Peregrine Pharmaceuticals,  Manager, Validation/QC, 1996-1997

Developed and validated analytical methods for a monoclonal antibody product in Phase III clinical trials. Promoted 1997.

•   Validated over 20 analytical methods, including SEC, ELISA, bioassays, and microbiological methods.

•   Created validation policy for the company, including writing of a Validation Master Plan (VMP), analytical methods and computer validation activities. 

•   Validated analytical equipment and computer systems (IQ/OQ/PQ). 

•   Developed and implemented Cleaning Validation program.

Peregrine Pharmaceuticals, Supervisor, QC, 1994-1996

Supervised the testing and release of finished product, in-process, and raw materials, using ELISA, HPLC, LC, and bioassay methodologies. Promoted 1996.

Gensia Pharmaceuticals (now Teva), Quality Control Chemist, 1993-1994

Used HPLC, GC, FTIR, and wet chemistry methods to test finished product and raw materials.

MacDonald-Stephens Laboratories, Chemist, 1992-1993

Used HPLC, ICP, GFAA to test environmental samples.

EDUCATION

·      University of Phoenix, 1998-2000, BS Business/Information Systems

·      UCLA, 1988-1993, Major: Biology