Current Openings

We are actively recruiting for the following positions:

• Director Clinical Development
  OVERVIEW:
  Responsible for all aspects of clinical trials/research and data collection activities associated with the development and evaluation of AlphaVax products. Provide leadership and staff management for development and implementation of clinical protocols and systems for data collection, analysis and reporting. Responsible for designing, implementing and interpreting results of clinical trials. Prepare relevant sections of IND’s, BLA’s and other documents for submission to the FDA.
  
  RESPONSIBILITIES:
  

  • Provide leadership to ensure establishment of the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of the company’s product candidates.
  • Oversee the creation, execution and reporting of clinical trial activities required to achieve FDA approval of new and experimental products and technologies in accordance with Good Clinical Practices (GCP).
  • This will involve planning, directing and interpreting results of clinical trials and interacting with internal and external groups to facilitate clinical trials and achieve designated timelines.
  • Ensure that appropriate assays, personnel and facilities are established to evaluate clinical trial specimens required to evaluate safety and immunogenicity.
  • Oversee the review of clinical trial data and, with other members of the management and scientific team, make decisions on product strategy.
  • Manage the work of others (employees and consultants) who perform the various activities associated with the successful evaluation and completion of clinical trial responsibilities. This may also involve working with product development teams, regulatory affairs, business development, and outside consultants to develop, implement, manage and evaluate clinical trials.
  • Provide involvement at an early stage in project planning and recommend the most appropriate medical input for project development plans.
  • Through effective planning, management of project resources and persuasive skills, ensure that all budgets, schedules and performance requirements are met.
  • Oversee safety monitoring, adverse event reporting and maintenance of required regulatory documentation, e.g. IRB approvals, patient consent, investigator agreements.
  • Develop and implement strategies, policies and procedures to be used within the medical affairs department.
  • Ensure contractual agreements with investigators meet business needs and legal requirements; work in conjunction with corporate counsel where needed.
  • Manage preparation of technical and scientific publications.
  • Perform other duties as required.

  
  QUALIFICATIONS:
  

  • Advanced degree (M.D or Ph.D. preferred) in immunology/vaccinology or equivalent experience and demonstrated mastery of clinical trial process. Experience in vaccine development is strongly preferred.
  • 8+ years experience in the biologics/pharmaceutical industry including 5+ years experience in the clinical trial process, with significant accomplishments progressing a new drug or biologic (ideally in several therapeutic areas) through clinical trials and FDA approval.
  • Demonstrated ability to achieve results in a dynamic environment while leading managers and others in a biologics or pharmaceutical organization from product discovery and research through approval and product introduction.
  • Knowledge of GCP, GLP and cGMP related to the biologics industry.
  • Knowledge and understanding of laws, regulations, and guidelines pertaining to vaccine or new drug development and registration. Knowledge of US and International regulations is necessary.
  • Demonstrated track record in effectively influencing decisions inside an organization, overcoming obstacles and driving efforts to completion.
  • Excellent strategic planning, organizational and creative problem-solving skills.
  • Strong oral and written communication skills with a demonstrated ability to participate in presentations to investigators, FDA, investors, funding sources, and other internal and external business contacts.
  • Scientific expertise in reading, assessing and interpreting preclinical and clinical data which can be translated and used in commercialization activities including development of clinical claims, advertising claims, promotional claims and new product opportunities.

  
  
  
• Director Regulatory Affairs
  OVERVIEW:
  This individual will direct all regulatory affairs efforts and requirements for AlphaVax. Provide professional expertise and strong leadership in the development and implementation of sound regulatory strategies, including meetings with FDA, CMC, clinical trial functions, and issues related to biological product development, submissions, and compliance.
  
  RESPONSIBILITIES:
  

  • Plan, organize and implement regulatory strategy for new biological products, specifically related to viral vaccine or viral vector vaccine technology.
  • Establish SOPs for effective operation of the Regulatory Affairs department. This will involve interface with other departments to oversee/coordinate the development of regulatory procedures and controls to ensure product compliance in a timely manner.
  • Plan, organize and prepare for meetings with regulatory agencies.
  • Plan, organize, and prepare documents and regulatory submissions for domestic and international product development and registration.
  • Participate in product planning, beginning at an early stage, to assure timely, smooth, and efficient development of regulatory submissions for clinical trials and product registration. Communicate clearly with each department to assure an understanding of requirements needed for submissions.
  • Develop and implement strategies for earliest approvals of all applications, IND through BLA..
  • Ensure timely preparation of organized and scientifically valid submissions, including INDs, to appropriate governmental agencies to meet regulatory requirements.
  • Coordinate all related government and compliance activities within the organization during and after inspections, or during regulatory actions by government agencies.
  • Demonstrate ability to exercise judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Recommend appropriate regulatory changes for labeling, manufacturing, and marketing to assure regulatory compliance.
  • Remain current with all regulatory requirements and standards necessary to develop and obtain licensure for therapeutic vaccines.
  • Develops and maintains effective working relationships with the FDA.
  • Perform other duties as required.

  
  QUALIFICATIONS:
  

  • MS or PhD with minimum of 7 years applicable experience in the regulatory affairs of biological products.
  • At least 5 years CMC experience related to regulatory affairs.
  • At least 3 years direct experience in the regulatory oversight of clinical trials.
  • Regulatory Affairs Certification (RAC) preferred.
  • Demonstrated scientific management, leadership and communication skills and the ability to operate in a team environment with commercial goals.
  • Willingness to be ‘hands-on’ and prepare the content of regulatory documents. Specifically, utilize scientific knowledge to extract necessary information from existing reports, or through communication with scientists, to draft regulatory documents for review and editing.
  • Knowledge of cGMP/GLP, GCP and Regulatory Guidelines as applied in start-up and mature biopharmaceutical companies.
  • Experience and knowledge in the preparation of INDs, NDAs, MFs, BLAs, and all amendments and supplements.
  • Demonstrated experience having primary responsibility for major regulatory submission including successful FDA interface/negotiations.
  • Demonstrated ability to participate in presentations for FDA auditors, investors, funding sources, and other internal and external business contacts.
  • Extensive knowledge and understanding of laws, regulations, and guidelines pertaining to new drug development/vaccine therapy and registration.
  • Knowledge of US and International regulatory practices and procedures.
  • Demonstrated ability to lead managers and others from product discovery and research through approval and product introduction.

  
  
  
• QC Analyst
  OVERVIEW:
  The Quality Control analyst is responsible for performing a variety of test procedures for raw materials, in process, and finished product, according to SOPs. These activities include stability studies for information testing of manufacturing process samples and compliance issues (calibration, maintenance and documentation of equipment). Test methods include working with cells using sterile technique.
  
  RESPONSIBILITIES:
  

  • Conducts routine and non-routine analysis of raw materials, in process, and finished formulations according to standard operating procedures.
  • Performs long-term stability testing on products, following stability protocols.
  • Reviews QC test results to ensure that specifications are met and that testing has been performed according to cGMP and GLP requirements.
  • Ensures that the laboratories are in cGMP and GLP compliance.
  • Compiles data for documentation of test procedures and prepares any required reports.
  • Calibrates and maintains lab equipment.
  • Performs special projects on analytical and instrument problem-solving, under supervision.
  • Involved with development, improvement, and qualification/validation of assays.
  • May assist with writing SOP’s as needed.
  • Performs other duties as required.

  
  QUALIFICATIONS:
  

  • BS in biological science or equivalent.
  • 3+ year's laboratory experience.
  • Assay Qualification / Validation experience.
  • Experience working in quality control or regulated environment a plus.
  • Familiarity with cGMP and cGLP requirements a plus.
  • Must be detail oriented and have good organizational and interpersonal skills.

  
  
  
• Senior Development Associate Scientist
  OVERVIEW:
  As a Sr. Development Associate Scientist, you will perform cell culture process development activities as part of a project team with a focus on developing methods and processes for the production of viral vaccines.
  
  RESPONSIBILITIES:
  

  • Perform vaccine production process development activities using roller bottles and stirred tank and disposable bioreactors up to 250L scale.
  • Optimize process conditions to improve product yield.
  • Advance scale up strategy for vaccine production.
  • Assist in developing large scale virus harvest procedures.
  • Implement new methods and technologies to enhance operations.
  • Support the design, installation and transfer of upstream process equipment and procedures into a cGMP facility.
  • Insure all materials are available and inventoried.
  • Develop and review SOPs, batch records, technical documents and reports.

  
  QUALIFICATIONS:
  A combination of education and industry experience:-
  

  • BS/MS with a broad background in small-scale bioreactor operation (stirred tank and disposable)/optimization, and GMP process development and tech transfer, ideally with practical knowledge of viral propagation.
  • 5+ year’s mammalian cell culture and process development experience.
  • Experience with anchorage dependent cell lines is a plus.
  • Experience with design of experiments and statistical analysis is desired.
  • Strong written and verbal communication skills as well as the ability to work in a cross functional team environment are required.
    
    

  
  
  
• QC Analyst - Lenoir
  OVERVIEW:
  The Quality Control analyst is responsible for performing a variety of test procedures for raw materials, in process, and finished product, according to SOPs. These activities include environmental monitoring withing the manufacturing facility and compliance issues (calibration, maintenance and documentation of equipment). Test methods include working with cells using sterile technique.
  
  RESPONSIBILITIES:
  

  • Conducts routine and non-routine analysis of raw materials, in process, and finished formulations according to standard operating procedures.
  • Performs environmental monitoring (total particulate counts, airborne vaibles, and surface viables) within the manufacturing suites.
  • Reviews QC test results to ensure that specifications are met and that testing has been performed according to cGMP and GLP requirements.
  • Ensures that the laboratories are in cGMP and GLP compliance.
  • Compiles data for documentation of test procedures and prepares any required reports.
  • Calibrates and maintains lab equipment.
  • Performs special projects on analytical and instrument problem-solving, under supervision.
  • May assist with writing SOP’s as needed.
  • Performs other duties as required.

  
  QUALIFICATIONS:
  

  • BS in biological science or equivalent.
  • 0-2 year's laboratory experience.
  • Experience working in quality control or regulated environment a plus.
  • Familiarity with cGMP and cGLP requirements a plus.
  • Must be detail oriented and have good organizational and interpersonal skills.

  
  
  

Please Note: Candidates who apply should describe specific related experience.

Contact Information:

If you are seeking an opportunity to contribute in a challenging, small-company environment, please mail your resume and salary history to:

AlphaVax, Inc.
Human Resources Department
P.O. Box 110307
Research Triangle Park, NC 27709-0307

If you prefer, you may email your resume and salary history to:

humanresources@alphavax.com

We offer competitive compensation, an attractive benefits package, the opportunity for professional advancement, and career growth. We are an Equal Opportunity Employer.