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Yyyyyy x. yyyyyy

Xxxxxx, XXXXXX xxxxxx (xxx-xxx-xxxx abc@xyz.com

 

 

Qualifications for Director of Business Operations

Enthusiastic Leader Committed to Driving Global Business Excellence, Strategic Team Building & Key Profit Maximization

 

Pharmaceutical Manufacturing Supply Chain Operations Governance Structure / Process

Business Process Definition Financial Controls / Practices Resource Allocation Communications

Product Portfolio Management Strategic Analysis / Planning Trends Tracking GMPs Compliance

Multi-Project Management Executive Advisement Process Optimization Continuous Process Improvement

Team Building Training / Development Talent Management Performance Metrics Procedure Development

 

Highly Accomplished Operations Leader who makes sound decisions to continually reflect positively on multi-site global manufacturing operations in alignment with a corporation s vision, value, and goals, and who sees the big picture at all times. Top Performer who offers solutions-centric critical thinking for insightful, change-oriented results, and who contributes a proven track record of stellar financial performance and successful metrics. Visionary Professional who rises above domestic and international business challenges to improve the bottom line and achieve winning outcomes, including quickly adapting to evolving global marketplace scenarios. Excellent Communicator who develops synergistic relationships with cross-geographical executives, vendors, business / manufacturing teams, and consumers, and who leads staff by example and with ethics and integrity.

 

Professional Synopsis

 

Pfizer, Inc. 2001 Present

 

Senior Operations Manager External Supply (Global Drug Product) (2004 Present)

Capitalize on the opportunity to direct forward-thinking global matrix Virtual Site Operations teams across a diverse product portfolio, including strategically supporting operating plan processes and forecasts, cost-effectively managing financial and budget responsibilities for $100+ million in global vendor spend across 10 CMOs, and maintaining or exceeding value proposition objectives to achieve GES and PGS goals. Continually serve as a Zero Defects Champion to lead transformative efforts across GDP. Collaborate with CMO site management and supply partners to lead operational and business review meetings. Expertly negotiate contracts and agreements and lead vendor selection teams to support objectives while managing enhanced product offerings, site transfers, new market launches, and line extension projects. Effectively represent Pfizer legal manufacturer for Software Medical Devices as the final authority for product release, including ensuring systems and resources were engaged for SMD compliance, supporting launch of multiple websites and mobile apps across up to 9 EU markets, and developing quality assurance and operational governance models for deploying compliant SMDs.

 

  Achieved 99.7% in-stock level for portfolio in 2016.

  Honored with 2017 s prestigious Pfizer W.E. Upjohn Award.

  Avoided $4 million in Pip-Taz inventory exposure to Catania site.

  Received Pfizer s Global Supply Mission Award in 2013, 2014, and 2015.

  Negotiated tandem pricing for Thelin to generate $500 million favorable PPV.

  Received Global Manufacturing Technology & Innovation Team Award in 2009.

  Coordinated planning activities for 100+ SKUs and 13 APIs across multiple global LOBs.

  Directed all operational initiatives of a legal entity cut-over project with 129 total SKUs.

  Led successful business process implementations for VMR and ERS and contract partners.

  Championed $7-million CIP and $250-million favorable PPV after a Toviaz package redesign.

  Maximized efforts to mitigate $427-million Protonix and $300-million Echothiophate exposure.

  Led global consolidation planning for FG, SFG, and API portfolio, including initial system set ups.

  Championed GES ISS initiative to achieve unprecedented visibility of export orders and demand.

  Personally led Ariba implementation team for GES, including managing all project roll-out efforts.

  Led technical manufacturing integration / transfer activities resulting from corporate acquisitions.

  Managed Chantix CR wallet implementation and presented an additional $4+ million opportunity.

  Honored for performance with Pfizer STARS Award Exemplifying the Leader Behaviors in 2006.

  Successfully avoided $2+ million in transfer costs by rationalizing portfolio at transitioning vendor.

  Recognized with Worldwide Pharmaceutical Operations Commercial Excellence Award in 2009.

  Avoided $400+ million exposure on Tygacil and $380+ million on Minocin via targeted negotiations.

  Developed a new operational model for managing contract partners via intermediate financial entity.

 

 

Yyyyyy x. yyyyyy (xxx-xxx-xxxx Page Two

 

Pfizer, Inc. (continued) 2001 Present

 

Manager Global Quality Assurance Services (2001 2004)

Led global quality assurance initiatives, including directing process validation for a 3-shift operation for a Brooklyn plant assignment (2003 2004). Advised manufacturing operations on continual process improvements, and reviewed quality assurance reports and approach to deviation management. Administered manufacturing and quality personnel training on executing validation protocols, and developed programs for product-specific validation studies. Directed multidisciplinary team GMP training on validation and change control for an entire site.

 

  Coordinated, managed, and endorsed product releases for validation lots.

  Received Pfizer STARS Award Exemplifying the Leader Behaviors in 2003.

  Developed and personally contributed to several Pfizer Quality Standards (PQSs).

  Participated on new product launch teams, including for Darifenacin and Vfend POS.

  Delivered ongoing validation leadership, training, advisement, and support to global sites.

  Led site support efforts and interim management roles in Brooklyn, Terre Haute, and Singapore.

  Served on a Site Validation Committee to lead validation documentation and change control approval.

 

Organon, Inc., West Orange, XXXXXX 1997 2001

 

Project Manager (1999 2001)

Strategically steered oversight of results-generating, GMP-related capital projects for production facility enhancement, including coordinating efforts across multiple disciplines to ensure seamless processes at all times.

 

  Noted for job excellence the Organon, Inc. s President s Recognition in 2000.

  Successfully managed a $500-million quality control laboratory expansion project.

  Co-led the core management of a major $50-million manufacturing expansion project.

 

Validation Engineer (1997 1999)

Designed and managed ethical pharmaceutical validation projects, including driving processes, equipment management and maintenance, cleaning, utility, and software efforts. Cohesively supported manufacturing operations for solid oral dosage and aseptic presentations. Prepared data for regulatory submission CMC modules.

 

  Proactively participated on new drug development teams.

  Developed and reviewed key protocols and detailed final reports.

 

Unigene Laboratories, Inc., Boonton, XXXXXX 1994 1997

 

Quality Control Engineer (1995 1997)

Spearheaded targeted analytical testing for drug product and process intermediates while validating HPLC instrumentation and assays for GLP compliance. Built productive operations by training analysts on sample prep, enzyme assays, and analytical instrumentation, including HPLC, UV, and TOC. Completed rigorous cross-training on microbiological laboratory techniques, and viable / non-viable environmental monitoring.

 

  Successfully supported consulting engineers in the design of a GMP facility.

  Upgraded lab-scale purification processes for high-volume commercial manufacturing.

  Developed validation protocols and quality assurance Standard Operating Procedures (SOPs).

 

Assistant Research Scientist (1994 1995)

Contributed sharp analytical abilities toward purifying peptidylglycine α-amidating enzyme using ion-exchange, reverse-phase, and gel filtration chromatographic techniques. Designed experiments and analyzed enzyme data.

 

  Successfully upgraded substrate / product analysis program for critical FDA approval.

 

Education & Professional Development

 

Master of Science in Management of Technology Polytechnic University

Bachelor of Engineering in Chemical Engineering The Cooper Union for the Advancement of Science & Art

 

Professional Engineer (PI) License State of Xxxxxx

Six Sigma Yellow Belt Certification Accrediting Agency

Master s Certificate in Project Management Stevens Institute of Technology

Project Management Professional (PMP) Certification Project Management Institute (PMI)

 

Board Member, Community Emergency Response Team, Xxxxxx, XXXXXX

 

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