Dennis Roberts

**** ***** ** ** . *******, WA ***12 . acceck@r.postjobfree.com . 206-

***-****

QA / QC Executive

QUALITY ASSURANCE / AUDITS / QUALITY CONTROL

INSPECTIONS / PERFORMANCE ANALYSIS / ASSESSMENT

SEASONED AND HIGHLY FOCUSED QUALITY ASSURANCE / CONTROL LEADER WITH PROVEN

PROFICIENCY GAINED THROUGH 20+ YEARS' SUCCESS GUIDING TEAMS TO IDENTIFY AND

REMEDY AREAS REQUIRING STRICT, LASTING, AND HIGH-IMPACT TURN-AROUND

INITIATIVES. SOLID HISTORY OF TRAINING AND MENTORING TEAMS TO MEET GMP AND

GCP REGULATIONS AND FOR REGULATORY SUBMISSIONS. POSSESS PHARMACEUTICAL AND

BIOTECHNOLOGY EXPERTISE IN API, STERILE DRUG PRODUCTS, AND SOLID ORAL

MANUFACTURING.

SOLID HISTORY OF OVERSEEING COMPREHENSIVE OPERATIONS WHILE DEVELOPING AND

DISSEMINATING REGULATORY DOCUMENTATION AND REPORTS. SKILLFULLY ALIGN

PROCESSES WITH INDUSTRY STANDARDS TO ADDRESS AUDIT FINDINGS. COORDINATE

WITH INTERNAL / EXTERNAL TEAMS AND VENDORS AS WELL AS GLOBAL PROFESSIONALS

TO MEET ALL GOALS.

AREAS OF EXPERTISE:

QUALITY/MANUFACTURING Manufacturing Project Management

TECHNOLOGY

Research and Analysis / Audits Quality Standards Assessment

Product Formulation / Health Authority (FDA, EMA)

Development Inspections

Regulatory and Industry Internal Systems and Controls

Compliance Operations Analysis / Process

Team Training & Mentoring Validation

Professional Experience

CELL THERAPEUTICS - SEATTLE, WA

Promoted through multiple positions of increasing scope and responsibility

to hold executive-level role overseeing product quality management

endeavors for top-performing pharmaceutical development company.

Vice President, Quality (11/2009 to 3/2013)

Created and implemented processes to align pharmaceutical manufacturing

operations with industry and legal regulations to include executing SOPs

and Quality Agreements in manufacturing, regulatory submissions, and vendor

selection / relations. Oversaw Quality Assurance for GMP compliance of

contractors (API, finished dosage), teams, and internal systems. Managed

Good Clinical Practice processes for investigators and CROs. Directed and

supervised teams, led team meetings, and served as key FDA representative

for company. Handled stakeholder / partner relationships. Identified

performance gaps and created SOPs to remedy inefficiencies and streamline

processes. Wrote and approved manufacturing reports; verified data and

conclusions for deviation and OOS investigations, CAPA, and change control

measures. Selected Contributions:

- Reduced labor costs related to managing training records by sourcing

and implementing a web-based training program.

- Bridged efficiency gaps through sourcing external resources in

training for GMP, GCP, risk management, and additional internal areas

requiring performance turn-around.

- Minimized negatively cited observations and optimized site corrections

by thoroughly preparing for FDA PAI inspections; led internal teams of

regulatory and SMEs to meet strict GCP requirements.

- Adeptly resolved critical FDA inspector identified analytical testing

issue at contract manufacturing site; site successfully passed

inspections following remedy measures.

- Administered ~$5M departmental budget while overseeing teams to meet

continued performance and compliance efforts during a revenue downturn

and budget cuts to <$2M.

Cell Therapeutics - Seattle, WA

Senior Director / Director, Quality Operations (6/2006 to 11/2009)

Supervised and managed team of 4 Quality Control Specialists and 1 Manager,

as well as 2 Document Control Specialists while handling complete

management functions for the Quality Group to include QC operations and

document control. Created and managed budgets. Oversaw external CMO and

contract testing lab operations. Handled processes for product releases

including methods and testing, stability program, and reporting. Managed

batch records, change control, SOPs, and specifications to align with

document control processes. Oversaw vendor teams. Participated in and led

CMC teams; contributed to regulatory filings; contributed to submission

process (IND, NDA, MAA). Selected Contributions:

- Optimized global team relationships through developing strong vendor

and staff partnerships.

- Served as leader during MAA negotiations with Dutch and German

Rapporteurs for Paclitaxel Poliglumex; served as the CMC expert.

Cell Therapeutics - Seattle, WA

CMC Contractor (6/2005 to 6/2006)

Chosen for contract role overseeing multiple QC endeavors; retained for

permanent role following contract closure. Managed transition of CMC

information on Trisenox (arsenic trioxide injection) during post-sale

stages to new company. Handled all QC testing of Paclitaxel Poliglumex

product (method change control, stability testing, specification

development). Maintained international relations with global managers,

scientists, and teams. Aligned all processes to meet deadlines and control

cost.

Cell Therapeutics - Seattle, WA

Director, Quality Control (7/2001 to 6/2005)

Collaborated on development and implementation of multiple quality control

measurements and improvement processes to meet industry and legal

regulations. Managed and led team completing project to validate terminal

heat sterilization of commercial product, Trisenox. Served as CMC expert

for coordinating with stakeholders involved with MAA for Paclitaxel

Poliglumex; improved product testing through selecting and validating

select QC test facility. Chosen to remain onboard during company's merger

and acquisition.

Additional Experience

Director, Product Development ( Akorn, Inc., Decatur, IL

- Managed to contract development leading to up to17% increase in

profits; built GMP compliant lab from ground-up to realize strong

profit center standing.

- Set record for speedy approval of oncology drug; delivered NDA

supportive documents for client, CTI, for Trisenox; hit goal 3 months

ahead of schedule.

Plant Manager ( Pegasus Labs, Pensacola, FL

- Redesigned and launched new manufacturing process for gelled calcium

supplement which resulted in a tripling of product output and improved

product quality and consistency.

- Reduced waste and improved materials accounting through overhauling

inventory system.

Analytical Chemist ( Steris Laboratories, Phoenix, AZ

- Increased robustness of methods through employing thorough literature

research review methods.

- Enhanced knowledge-sharing by improving efficiency of lab notebook

maintenance.

- Identified and corrected sampling method errors for testing Metered

Dose Inhalers.

Education and Credentials

BACHELOR OF SCIENCE IN CHEMISTRY ( WASHINGTON STATE UNIVERSITY - PULLMAN,

WA

Member, Parenteral Drug Association, 9/'01 to 10/'12

Technologies: Microsoft Office Suite (Word, Excel, PowerPoint, Outlook),

Livelink, Eduneering, Agilent Chemstation, Stability management database,

Novell network, and NovaTek stability

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