Julie Ross-Kramer

***** ********* **** 805-***-****(C)

San Diego, CA 92128 aczqzn@r.postjobfree.com 858-***-****(H)

Manufacturing operations professional

Pharmaceuticals Oligonucleotides Medical Device In-Vitro Diagnostics

Results-oriented biotechnology manager with 10+ years leadership experience overseeing effective and efficient processes and procedures that significantly contribute to company’s bottom line. Successful in building and leading cohesive teams that continually make significant contributions and exceed company expectations. Exceptional interpersonal, communication and presentation skills, proficient in collaborating with internal and external partners. Innate ability to lead of all aspects of operations including material procurement, inventory control, SOP revisions, process improvement, production planning, and scheduling.

Areas of Expertise

Business Process Improvement

DMAIC

Inventory Control & Management

Production Planning & Scheduling

Strategic Planning & Implementation

Process Design & Validation

GMP and ISO 13485 Compliance

Technical and Leadership Training

Cross Functional Management

Project Management

CAPA and Non-Conformance Management

Process Mapping

Tech Transfer

Metrics and Trend Analysis of KPI

Professional Experience

Associate Director, manufacturing OPERATIONS August 2014 – Present

Senior Manager, Manufacturing December 2011– August 2014

Catalent Pharma Solutions (Formerly Pharmatek Laboratories) San Diego, CA

Transformed and professionalized production team; directed daily schedules of production team; expanded operations to cover multiple shifts; established GMP support functions to support and facilitate production; established scalable management structure for the production department.

Chartered robust technical training program to develop skills of the production technicians through collaborations with Engineering and Quality departments. Resulted in 85% drop in deviations caused by operator error. Currently acting as the program manager for the manufacturing department.

Managed production variances and CAPA with QA department to improve processes.

Applied Lean Six Sigma principles to reduce variation and increase efficiency in production suites.

Successfully managed over 600 GMP production runs of oral dosage forms.

Operations Manager, Pilot Production October 2010 – December 2011

Reva Medical San Diego, CA

Established and directed formal operations functions supporting production of pre-clinical and clinical supplies; collabored directly with Engineering, Quality and upper management to drive method transfer, training and document completion; oversaw and led all production, logistics and quality control of coronary stent production.

Directed the implementation of formal documentation, training and processes to support clinical production compliant with the FDA QSR and ISO 13485 standards.

Expanded and developed production and quality teams to meet forecasts in support of design validation and clinical trials.

Developed and implemented the use of assessment and evaluate new hires in production and quality control.

Production Manager May 2009 – October 2010

Eurogentec, NA San Diego, CA

Recruited to establish Production, Quality Control and Operations systems and processes for in-vitro diagnostic oligonucleotides while ensuring compliance with cGMP and ISO 9001/13485 regulations.

Achieved certification for ISO 9001/ISO13485 by driving efforts and creating collaboration with partners including Quality Control, upper management to establish procedures, conduct training, and facilitate efficient method transfer.

Significantly contributed company’s bottom line by improving production processes for highly modified and complex oligonucleotides; established Facilities Department which managed equipment and calibrations; created Logistics Department which oversaw purchase orders, inventory, shipping and receiving.

Implemented metrics to measure performance and identify areas of improvement.

Production Manager March 2008 – May 2009

Illumina, Inc. San Diego, CA

Recruited to direct the high-throughput oligonucleotide, bead pool, and Veracode in-vitro diagnostic manufacturing groups to support 24/7 operations; ensured compliance through proper training and lead cross-functional project to identify and implement replacement solvent due to acetonitrile shortage.

Hired, trained and implemented 24/7 operations and production of Veracode bead plates; collaborated with Human Resources, Engineering and upper management in implementing management of production plan.

During world-wide acetontrile shortage, organized and lead a project team which identified substitues; and other mitigations including conserving use and seeking alternate sources;

Successfully implemented documentation and training plan for cGMP compliance for diagnostic products

Scientist,Core Lab Manager, Thousand Oaks, CA July 2002 – March 2008

Senior Associate Scientist & Lab Supervisor, Boulder, CO April 1994 – January 2002

Amgen, Inc.

Directed daily operations for the oligonucleotide synthesis group; supervised and mentored staff; tracked monthly production metrics, managed process improvement projects; conducted internal audits and established lab SOPs.

Lead critical benchmarking studies to monitor competitiveness of our group vs external servive providers

Facilitated automation of laboratory processes and integration of automation with lab instrumentation and order processing systems

Collaborated with R&D and IT to develop new approaches to protein and antibody engineering

Recognized for designing new production process that cut purification costs by 40%, increased capacity by 80%, and reduced FTE time required to run the process by 50%;

Slashed hazardous waste volume by 50% with the implementation of new synthesizer protocols.

Education and Training

Lean Six Sigma Green Belt, UCSD – April 2017

Master of Science - Computer Information Systems, Regis University, Denver, CO

Graduated with Honors

Bachelor of Arts - Molecular, Cellular, & Developmental Biology, University of Colorado, Boulder, CO

Employment Law for Managers Career Coaching Applied Employee Relations

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