Libet Sarkissian
Tarzana,CA
Summary
Over twelve years of finance and fifteen years of project management experience. Commercialization project manager driving the development, creation, and implementation of high quality, global, coordinated cross-functional complex project plans for products in accordance with the program strategy and filings.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Commercialization, Prog and Portfolio Mgmt – Inflammation Project Manager
Amgen Inc
01.2020 - Current
- Support cross-functional drug development and commercialization activities of pipeline products at Amgen
- Lead the Marketing Application filing for partner program Omecamtiv Mercabil and Supplemental License Application (sBLA) process for Enbrel’s Juvenile Psoriatic Arthritis (JPAsA) sBLA
- Experience in leading work package teams: Evidence Generation Teams (EGT), Integrated Brand Team (IBT) and Product Delivery Teams (PDT)
- Experience leading governance process for Patient Impact Expansions (PIE) indications for PG approval with partner
- Develop and lead the cross-functional execution of the license FDA application with partnered Rocatinlimab program
Results Delivery Office (RDO) - Senior Associate Finance / Project Manager (PM)
Amgen Inc
01.2017 - 01.2020
- Lead initiatives Prioritization Audit Process for 40 initiatives to assess financial, staff impact and initiative progress
- Implement new processes, including outlining current state and proposing improvement opportunities
- Develop executive communication to RDO SLT members and CEO
- PM for Excellence Value & Access Initiative: facilitate weekly meetings for (GHE & Market Access), tracking of deliverables, action items and goals
- PM supporting the transition of Otezla from partner BMS to Amgen
Senior Associate Strategic Planning & Ops
Amgen Inc
01.2014 - 01.2017
- Project manager for Container Science Engineering: facilitating governance meetings, tracking of deliverables and action items, managed financial, resourcing, training reports, NC/CAPA/Change Control, Goals, Metrics
- Manage GMP equipment transfer project to Quality Inspection department in Puerto Rico and Ireland: developed charter, created project timeline, held weekly cross-functional team meetings with core team, agendas and meeting minutes
- Successfully manage departmental training, compliance and qualification of Good Manufacturing Product (GMP) Suppliers, including but not limited to on-boarding and auditing of external contractors
Associate Project Manager
Amgen Inc
01.2012 - 01.2014
- Lead cross-functional teams (clinical, call center, CMQ, SQM, regulatory and IS) to progress AMG 785 Autoinjector/Pre-Filled Syringe Clinical hypercare program: created project timelines, analyzed complaints data, maintained a communication plan, reported status, held weekly meetings for tracking and reporting purposes
- Lead cross-functional teams (Global Supplier Sourcing, Legal and Quality) to ensure proper qualification of Good Manufacturing Practices (GMP) Suppliers, contractors and consultants per FDA’s 21 CFR part 820.50
- Managed all financial analysis (spend and forecasting) for device programs 66M; led monthly meetings with Sr Management and VP, processed capital projects through Investment Lifecycle Management process
Project Coordinator
Amgen Inc
01.2006 - 01.2012
- Lead and plan budget for on-site coordination and logistic execution of annual Advisory Board conferences
Education
Master of Business Administration - Management
California State University Northridge
Northridge, CA12.2010
Bachelor of Arts - Law and Society
University of California Santa Barbara
Santa Barbara, CA06.2002
Certified Six Sigma Green Belt / Design for Six Sigma Yellow Belt, Black Belt Trained -
Amgen
Thousand Oaks06.2012
Skills
- Project management
- Conflict resolution
- Attention to detail
- Ability to collaborate effectively in partnered programs
- Successful stakeholder engagement at all levels including executives
Accomplishments
- Successfully filed Enbrel's Juvenile Psoriatic Arthritis (JPsA) sBLA
- Successfully completed the submission of Rocatinlimab in 9 weeks from last pivotal studies Flash Memo
Certification
- Certified Six Sigma Green Belt
- Design for Six Sigma Yellow Belt
- Black Belt Trained
Languages
Spanish
Native or Bilingual
Timeline
Commercialization, Prog and Portfolio Mgmt – Inflammation Project Manager
Amgen Inc
01.2020 - Current
Results Delivery Office (RDO) - Senior Associate Finance / Project Manager (PM)
Amgen Inc
01.2017 - 01.2020
Senior Associate Strategic Planning & Ops
Amgen Inc
01.2014 - 01.2017
Associate Project Manager
Amgen Inc
01.2012 - 01.2014
Project Coordinator
Amgen Inc
01.2006 - 01.2012
Master of Business Administration - Management
California State University Northridge
Bachelor of Arts - Law and Society
University of California Santa Barbara
Certified Six Sigma Green Belt / Design for Six Sigma Yellow Belt, Black Belt Trained -
Amgen