Manufacturing Medical Device
Resume:
Bachelors degree preferred, plus *-* years of relevant area experience in the Pharmaceutical, Medical Device, or other healthcare industry. 2+ years in quality related role Knowledge of health authority
regulations (FDA, EU, etc.) Experience in one or more basic quality systems roles (i.e. SOP development, CAPA, Training, Internal/External Audit, etc.) Strong knowledge in Inspections, Internal Audits,
Management Review, and CAPA.
Rachel Grace Luchs
1433 Natalie Lane, Ann Arbor, MI 48105
*******@*****.***
(c) 734-***-****
SKILLS
Auditing for Compliance Operational Efficiency/Lean Manufacturing
Change Management / Implementation Organizational Skills
Planning Risk Assessments
Investigations (i.e. CAPA) SOP W riting and Reviewing
Process Improvements/Optimization System Development
Project Management Training
ACCOMPLISHMENTS
10+ years of experience in pharmaceutical drug development.
7+ years of experience working in clinical manufacturing operations.
key contributor in launching a clinical phase III trial for an autologous stem cell therapy. Contributions
included supporting the development, qualification and regulatory submission of the manufacturing
process.
outfitted a cGMP class 100K facility. Participated in facility design/configuration and established the
operating systems to maintain classification status.
experience with defining end-user software specifications, designing and executing User Acceptance
Testing (UAT) and implementing an interactive web-based recognition system (IWRS) and
TM
AutoloTrack, a customizable small-scale manufacturing execution system.
PROFESSIONAL EXPERIENCE
Aastrom Biosciences, Inc., Oct 2001 to May 2013
Aastrom is a publically held company focused on developing cell therapy products for use in regenerative medicine.
Aastrom’s proprietary technology is used with autologous stem cells to create a patient -specific treatment for severe
cardiovascular diseases.
Consultant, Apr 2013 - May 2013
provided guidance and training on manufacturing support systems including scheduling, batch record
issuance and clinical product disposition.
GMP Operations Coordinator, Apr 2011 - Apr 2013
GMP Trainer
o created and maintained training program which included GMP orientation, operations on-
boarding and current technical qualifications.
o coordinated tech transfer activities for Technical Operations including process transfer,
document review and approval, knowledge transfer, and process support.
o supported change control, deviations and CAPA systems to ensure compliance.
o designed and managed internal manufacturing SharePoint site.
Scheduler
o confirmed capacity, resources, and logistics for clinical manufacturing.
o solved scheduling conflicts which required a strong understa nding of the complex and layered
scheduling constraints and requirements involved in manufacturing a cell culture process for
clinical use.
o evaluated preclinical and research protocol design for operational impact and coordinated
protocol execution, including data reporting.
R. Luchs Resume Page 1 of 2
Bachelors degree preferred, plus 5-7 years of relevant area experience in the Pharmaceutical, Medical Device, or other healthcare industry. 2+ years in quality related role Knowledge of health authority
regulations (FDA, EU, etc.) Experience in one or more basic quality systems roles (i.e. SOP development, CAPA, Training, Internal/External Audit, etc.) Strong knowledge in Inspections, Internal Audits,
Management Review, and CAPA.
Planner, Jan 2010 - Apr 2011
effectively maintained master plan for manufacturing operations which included project scope
definition, prioritization and project tracking.
defined and maintained process flows for all systems in manufacturing to understand
touchpoints/change impact and to support lean manufacturing.
developed and implemented systems for internal document review process.
created scheduling system to address bone marrow procurement, ordering processes for both
Clinical and R&D and resource coordination for Production, Materials, Equipment, QC and QA.
Manufacturing Supervisor, Jan 2007 - Dec 2009
responsible to ensure facility was GMP compliant.
made time critical decisions to resolve operational issues affecting areas of compliance, safety and
efficiency.
performed batch record review for product release.
led root cause analysis and implemented CAPA for production-related investigations.
summarized production metrics for continuous improvements and risk assessment.
responsible for audit responses and served as technical lead for external supplier audits.
prioritized and managed projects to support operations.
Senior Production Associate, Sept 2006 - Jan 2007
same as Production Associate responsibilities below.
represented production cross-functionally to provide operational and GMP feedback to support
process definition.
launched internal audit program to correct and prevent failures and improve operational efficiency.
Production Associate, Feb 2006 - Sept 2006
performed GMP production and release testing using aseptic technique to support multiple clinical
phase II studies.
generated protocols and work instructions to standardize the manufacturing process and
demonstrate GMP compliance.
performed cleaning and environmental monitoring of GMP facility.
Research Associate, Oct 2001 - Feb 2006
provided lab support for Immunotherapy Program. Aastrom’s Immunotherapy Program managed
multiple Small Business Innovation Research (SBIR) Phase I and clinical phase I grants focused on
a variety of dendritic and t-cell-based vaccines.
participated in experimental design process.
executed cell culture techniques (i.e. managed cultures from both flasks and large -scale automated
culture device, immunohistochemistry, and microscopy).
maintained a GLP notebook, analyzed and presented data.
University of Michigan, Morrison Lab, Dept. of Internal Medicine & Genetics, May 2000 - Oct 2001
The Morrison Stem Cell Lab discovered that stem cells persist throughout adult life in the peripheral nervous system
(PNS), where they were not previously believed to exist. This discovery led to a potential new role of stem cells in
PNS repair.
Research Associate, May 2000 - Oct 2001
performed basic cellular and molecular biological techniques (i.e. cell culture, microscopy,
immunohistochemistry, PCR, gel electrophoresis, DNA/RNA extractions).
maintained lab by performing duties such as inventory management, SOP management and trained
graduate students on lab procedures.
managed transgenic mouse colony (i.e. breeding schedule, genotyping).
EDUCATION
BACHELORS OF SCIENCE, Biopsychology & Cognitive Science, UNIVERSITY OF MICHIGAN, May
2000
R. Luchs Resume Page 2 of 2
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