Manufacturing Medical Device

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

ab9pwl@r.postjobfree.com

(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

Contact this candidate