Renata Kovalski, MBA

Current

Biopharmaceutical Professional (Self-employed)

Past

Global Operations Team Leader at Amgen
Project Manager at Amgen
Quality Assurance Associate at Amgen

Quality Assurance Specialist at Diagnostic Products Corporation

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Education

Pepperdine University, The George L. Graziadio School of Business and Management
University of California, Santa Barbara

Connections

291 connections

Industry

Biotechnology

Renata Kovalski, MBA’s Summary

Strategy development and execution in operations, clinical development, regulatory submissions and product launches. Specialized recruitment services.

Over 13 years experience in cross-functional drug development, team leadership and complex project management in the biopharmaceutical industry. Results-oriented, strategic and global thinker with excellent team leadership, interpersonal and communication skills. Able to balance business needs with regulatory, clinical and operations risks.

Part-time faculty at Moorpark College teaching Biotech Business and Government Regulations course which is included in the two-year Biotechnology Certificate Program curriculum.

Renata Kovalski, MBA’s Specialties:

Specialized recruiting services. Strategy development and execution, tactical plans for product/project life cycle management, risk management, portfolio management, change management, stakeholders’ communication, decision points and milestones management.

Renata Kovalski, MBA’s Experience

Biopharmaceutical Professional

Self-employed

(Self-Employed; Myself Only; Biotechnology industry)

September 2006 — Present (2 years 4 months)

Cross-functional drug development strategy execution, tactical plans and implementation in the operations (CMC), regulatory, and clinical development areas. Specialized talent recruitment.
Global Operations Team Leader

Amgen

(Public Company; 10,001 or more employees; AMGN; Biotechnology industry)

October 2003 — March 2006 (2 years 6 months)

-Successful US/EU approval and launch of oncology product, Kepivance
-As part of the global Product Strategy Team: develop product life cycle strategy including Executive Management communication, manage partnerships, develop and execute commercial and clinical product strategies.
-Product portfolio prioritization within the human resources and production capacity; provide guidance for functional budgets, eliminate gaps and ensure goal alignment.
Project Manager

Amgen

(Public Company; 10,001 or more employees; AMGN; Biotechnology industry)

November 1998 — September 2002 (3 years 11 months)

-Manage development of proteins, peptibody and small molecules from pre-FIM/ph1 through commercialization.
-Cross functional product strategy development and management of IND/BLA/NDA/MAA regulatory filings.
-Lead and manage complex drug development partnerships and CROs ensuring timely phase 3 trials execution and regulatory submissions.
-Licensing evaluations including drug development scenario analysis providing R&D costs for P&L/NPV analysis.
-Manage Amgen's first corporate wide change effort in the Corporate Office of Program and Change Management. Provide structure and direction to 7 functions, over 20 sub-teams, and 150+ global change projects.
Quality Assurance Associate

Amgen

(Public Company; 10,001 or more employees; AMGN; Biotechnology industry)

November 1996 — October 1998 (2 years)

-Conduct compliance audits of facilities, processes, and systems in Mammalian and Microbial production plants
-Analyze and present product quality results including Annual Product Review.
-Trend and analyze environmental, bioburden, and utilities systems data to identify adverse patterns; investigate excursions and write technical reports identifying trends and corrective actions
Quality Assurance Specialist

Diagnostic Products Corporation

(Privately Held; 501-1000 employees; Medical Devices industry)

October 1994 — October 1996 (2 years 1 month)

-Perform gap analysis for ISO 9001 registration; trend, analyze and present monthly reports at Management Quality Review Board Meetings
-Supervise and execute validation projects including IQ, OQ and PQ