Kristine Afanse

I have taken the liberty of summarizing my background for your consideration.

I offer several years’ experience as a Director of Business Development within the Western, Europe and APAC region providing my employers and clients with highly productive, profit-oriented and cost-conscious service. I have excellent social skills and a professional attitude. I have strong communication skills and the ability to prepare and make presentations to decision-makers on all levels. I’m very familiar with the regulatory process, contract negotiations, and financials. Essential duties and responsibilities may include the following but other duties may be assigned.

• Identified, Generated and closed sales opportunities with pharmaceutical, biotech, medical device, and CRO accounts.

• Experience/Contacts in North America, Europe, and China

• Increased Cytovance, FMD, SGS, and Cardinal Health's projected potential revenue by acquiring new business.

• Developed and implemented sales management and advertising strategies resulting in increased sales for companies represented.

• Experienced in selling all phases of clinical trials (phase I-IV) and Data Management-Biostatical services.

• Ensured compliance with FDA, EMA and CFDA guidelines.

The enclosed confidential resume summarizes my background and experience.

I look forward to the opportunity to discuss your short and long term objectives and my ability to direct your organization toward successfully achieving these goals. Should you require additional information prior to our meeting do not hesitate to contact me and I look forward to speaking with you soon.

Sincerely,

Kristine Afansev

Kristine Afansev

OBJECTIVE:  To obtain a challenging Business Development position within the Clinical Research or Clinical Manufacturing arena. 

Specialties: Product and Project Development, Business Development, Account Management, Global Strategic Marketing, New Product Planning, Domestic and Global Product and BD Launches, Brand Management, Market Development, Market Research, Customer Insights,  Alliance Management, Strategic Partnerships, Academic Partnerships, Talent and Team Management, FDA/CFDA/USDA/NMPA and EU Regulatory Affairs Specialties, Business Development Strategies, Business Contract Negotiations, Master Service Agreements, Intellectual Property Collaborations, Partner Agreements, Public Relations, Viral Vectors, Clinical Development Manufacturing, Cell, and Gene Therapy.

Overview: I am an interactive Head of Business Development for science-based Business Development, Marketing, and Project Management in the global Biotech, Pharmaceutical, Medical Device, Clinical Research, Viral Vectors and Cultivated Meat industries. I provide Senior Executive experience in client contract building, retention, and project management, managing both new and established clientele to ensure diverse and expanding market coverage. 

My reputation is in formulating high-level negotiation tactics and discovering emerging opportunities with a proven record of forming result-based synergies linking client and company production. International and National organizational growth through business development expansions, partner collaborations, alliances, and execution of assertive profit developments. Leadership skills to facilitate production and build world-class organizations for your business solutions.

Profile: An in-depth scientific knowledge base of the clinical research continuum (Pre-clinical thru Phase IV, Manufacturing, pharmacoeconomic), Commercial Market intelligence, and Regulatory compliance. Indications include Oncology, Respiratory, Cardiac, Metabolic, Immunology, Hepatic, CNS, Infectious Diseases, Vaccines, Oncolytic Viruses, Viral Vectors, Clinical Development Manufacturing, Cell, and Gene Therapy

•  Over 15+ years of successful performance in biotech/biopharmaceutical sales and business development.  
• Successful at identifying new business opportunities and closing large business transactions.
• Effectively direct internal and external project teams during complex, cross-functional sales processes.
• Extensive network of Executive level decision-makers and consultants.
• Strong creative energy with a proven track record to establish, achieve and surpass goals. 

EXPERIENCE:

Exothera SA                                                                                                                                    11/2022-Present

Head of Business Development

• Provided customized Process Development and GMP manufacturing services for a Belgium-based viral vector CDMO.
• Generated 100% new business within the United States.
•   Responsible for developing business relationships with clients to support their manufacturing strategy and help accelerate their small to large-scale GMP clinical and commercial production of

viral vectors.

• Instrumental in generating brand awareness for Exothera through the use of an extensive existing and new network of high-level contacts.
• Design, develop, and execute business development activities for gene therapy, vaccines, and oncolytic viruses.

JOINN Biologics                                                                                                                                     11/2020-5/2022

Head of Business Development- International

• Generating 100% of New Business Internationally for JOINN Biologics
• Negotiated and closed deals in the Biotech and Cultivated Meat industries.
• Formulated an MSA to be compliant with cGMP per 21CFR117.
• Worked with the FDA to register our facility as a food manufacturing facility.
• Successfully generated over $20 million in newly signed contracts.
• Experience in tech transfer of animal cell culture process and animal cell culture optimization for biomass production at 10L up to 1,000 L scale
• Worked with both suspension and microcarrier.
• Design, direct, and execute business development activities for CMC’s mammalian and cultivated meat services internationally.

Cytovance Biologics, Inc. a Hepalink Co.

8/2017 – 10/2020

Senior Director, Business Development-West Coast                                                    

• Responsible for establishing and building Cytovance’s US and APAC presence. 
• Drive revenue growth through the development and implementation of strategies to generate sales from new accounts for the western half of the United States. 
• Design, direct, and execute business development activities for CMC’s mammalian and microbial contract manufacturing services in the Western USA and APAC sales territory.
• Successfully generated over $100+ million in newly signed contracts for Drug Substance clinical manufacturing agreements.
• Successfully negotiate Master Supply and Commercial Supply Agreements.
• Awarded long-term partnership agreements with several Global Pharmaceutical companies generating consecutive projects.
• Instrumental in generating brand awareness for Cytovance Biologics through the use of an extensive existing network of high-level contacts.
• Established a strong network of Biopharmaceutical industry consultants, further elevating visibility for Cytovance’s capabilities and driving business in all regions.

George Clinical

8/2015 - 6/2017

Sr. Director of Business Development                                                                                

• Responsibilities included generating 100% new business and ensuring appropriate communication channels were maintained for my prospects and customers. Ensured that key customer expectations transcend, and the organization adhered to standard operating procedures across all projects.
• Led the review of a customer pipeline, opportunities pending, and future customer needs in support of the weekly development of resource forecasts for delivery to the cost centers providing resources to the designated customer account. 
• Sold over 12.2 million in revenue and pipeline opportunities for the company in a little over a year. 
• Provided weekly forecasts and reports for internal and corporate use in conjunction with Life-cycle management within numerous therapeutic indications.

Fountain Medical Development                                                                                      

12/2013 - 6/2015

Senior Director of Business Development and Project Management for USA, China, and Europe

• Generated 100% New Business for US, Asia, and European Biotech, Pharmaceutical, and Medical Device companies to conduct Phase I-IV, Bioanalytical, and DMPK. Clinical studies in China.
• Developed new business for Data Management and Biostatistical Analysis in US, EU, and China.
• Provided commercial development, strategic marketing, and brand building to increase revenue and brand development.
• Executed my Project Management skills to help direct companies through the IND-NDA development with the Chinese Food and Drug Administration.
• Established strategic partnerships with other CRO’s providing a true International Business plan. 
• Helped organizations navigate through the complex CFDA Regulatory Affairs process.
• Provided weekly forecasts and reports for internal and corporate use.
• Life-cycle management within numerous therapeutic indications.

Cardinal Health-                                                                                                 

12/2010 - 12/2013

Director of Business and Project Development- West Coast

• Generated New Business with Pharmaceutical, Medical Device, and Biotech companies to bring new products to market.
• Provided Regulatory, Product Development, Chemistry Manufacturing Control, Compliance, Early Stage Clinical, Late Stage Clinical, Phase IV, Quality, and Publishing support services across a wide range of therapeutic indications. 
• Project Manager for leading Pharmaceutical and Biotech companies on the West Coast.
• Generated 100% new business within the Western Region of the United States.
• Attend regional and national symposiums to generate new business.
• Qualified new business through sales leads, by phone, email, and in person.
• Provided weekly/monthly sales forecasts.
• Generated 5 million in New Business within 12 months.
• Worked closely with internal divisions including legal, contracting, and marketing to develop and successfully complete new projects.

Education

California State University, San Bernardino

B.A. Mass Communication, Graduated 1996

Kriger Research Center- Clinical Research Associate Program + GCP 

Project-Management Certification Program- Learn Smart

Bachelor of Arts, PM as a Charter- Global Registered Education Provider (REP)

Bachelors from California State University