SASHA A.

ZBITNOFF
28 Brandon Rd.
Haverhill, MA 01832
Home: (978) 374-1401; Mobile: (978) 886-1312
szbitnoff@gmail.com

SUMMARY:
Versatile professional with 15 years experience driving broad scale programs while fostering
a strong collaborative environment. Extensive experience working in global pharmaceutical
companies and effectively leading global programs supporting Quality, Manufacturing and
Drug Development initiatives with an eye toward continued efficiencies.

Proven Track Record of:

 Organizing and launching new programs and initiatives across companies, sites,
functions and levels
 Facilitating cross-functional teams to realize and map toward mutual interests to meet
organization needs
 Managing risks and mitigation strategies to ensure continued awareness and process
improvement opportunities
 Establishing metrics and communications tools to realize efficiencies and ensure
continued visibility and awareness
 Maintaining valuable relations across an organization to foster an environment toward
continued success
EXPERIENCE:
2010 Lonza Inc. Portsmouth, NH
Sr. Product Manager
Lead and manage multi-disciplinary teams in the successful delivery of
finished drug products for regulatory submission and commercialization. Work
with project leads of API (drug substance manufacture or supply), formulated
production (drug product), Regulatory Affairs (compilation and submissions),
Clinical (Biostudy and GCP) and Commercial (initial launch and supply to
market). Ensuring cost and quality objectives are met in accordance with
schedule expectations.
2007 – Syntonix Pharmaceuticals, a subsidiary of Biogen IdecWaltham, MA
2010 Sr. Program Manager
Shepherd drug development candidates through pipeline. Work closely with
Program Executive and functional leads to advance development programs.
Supported the Hemophilia programs Factor IX-Fc and Factor VIII-Fc, and a
peptide program targeting auto-immune diseases. Key accomplishments:
 Advanced FIXFc program from pre-clinical, in 2007, to registration trials,
in 2010. Moved FVIIIFc from late-stage discovery to Phase I in same time
period.
 Drafted integrated development plans for both FIXFc and FVIIIFc
hemophilia programs and CMC development plan for FIXFc program to
document and align team strategy.
 Built and maintained comprehensive program schedules. Developed
customized schedules to facilitate effective planning and alignment (e.g.
regulatory filings; initiating clinical trials).
 Managed and facilitated Joint Core team to advance program objectives,
while effectively tracking and managing program issues and needs.
  Ensured effective relations with Biovitrum, Swedish co-development
partner for hemophilia programs, ensuring productive communications to
maintain forward momentum.
 Supported US and international regulatory filings (including EU, Hong
Kong, India and China) to advance global clinical program.
2001 – Wyeth BioPharma Andover, MA
2007 Project Manager (2005 – 2007)
Project Manager for commercial production of Herceptin, supporting Wyeth’s
role as a contract manufacturer for Genentech.
 Facilitated Joint Project Sub-teams (Quality, QC, Engineering, Technology,
and Supply Chain). Administrated Executive Steering Committee, and
Technical Operations Committee.
 Managed team of Compliance Coordinators to conduct investigations,
perform suite walkthroughs, and lead initiatives to ensure compliant
operations.
Sasha A. Zbitnoff Resume Page Two
Wyeth BioPharma
Compliance Manager (2001 – 2004)
Managed multiple efforts for the Network (Global) Quality Unit supporting all
BioPharma sites: Andover, MA; Grange Castle, Ireland; St. Louis, MO. Key
accomplishments:
 Ensured successful start-up of Quality Unit in Grange Castle, Ireland.
Developed charter and project plan; managed monthly Quality forums,
provided direction for new personnel, facilitated planning sessions, and led
staff meetings until Quality leadership team was in place.
 Established Wyeth BioPharma’s program to contribute to Wyeth-wide
conformance standards governing GMP quality systems (e.g. Investigations,
Change Control, Tech Transfer, etc.). Managed development teams for
Conformance Standards; led management meetings, and chaired oversight
council.
 Facilitated Quality Partnership between Wyeth Europa and Wyeth BioPharma
to ensure effective relations to appropriately support BioPharma products in
Europe.
 Contributed to numerous multi-site initiatives including the BioPharma
Compliance Council, Multi-site GMP Documentation, BSE/TSE Advisory Group,
Training, etc.
1996 − The Boston Consortium for Higher Education Wellesley, MA
2000 Program Manager (1998-2000)
Central contact and initiate for cross-institutional initiatives between eleven
premier colleges and universities to pursue mutual learning / cost
containment opportunities.
 Developed two web-based training programs addressing OSHA and EPA
requirements
 Established “Preferred vendor” IT Training relationships realizing over $100k
savings
 Executed two technical job fairs, resulting in numerous hires for member
schools.
 Supported two retreats strengthening the Consortium’s community and
collaboration.
Consortium Coordinator (1996-1998)
Launched the Consortium from a one-person operation to an established
organization; launched its first multi-institutional training program.
1995 – Euromoney Magazine London, UK
1996 Research Assistant
Conducted numerous research projects and surveys for published articles and
reports.
Summer Applied Scholastics Beijing and Urumqi, China
1989 Assistant Teacher
Taught English as a second language in China for six-weeks, shortly after the
1989 Tieneman Square incident in Beijing.
EDUCATION:
Babson College Wellesley, MA
 Master of Business Administration, June 2008
University of New Hampshire Durham, NH
 Bachelor of Arts in Philosophy, May 1995
 Magna Cum Laude
Biopharmaceutical Training / Education
 Introduction to Operational Excellence / Red Belt Six Sigma Training (Wyeth)
 Project Management in Pharmaceutical Manufacture (IVT)
 Drug Development Process (Wyeth)
 Biopharmaceutical Process Development (ISPE)
 BioPharma: Mastering the Business of Science (Babson Executive Education)
 Sterile Manufacturing: Formulation, Manufacture and Control (CFPA)
 Biotech Industry Basics: Fundamentals of the Biotechnology Industry (ISPE)
 QA Auditing Course (Temple University)

References Available on Request