Job vacancy Project Manager & CMC Senior Manager

Our firm is searching for two Biologics Business Executives, experts in their respective fields to become part of a highly qualified and experienced team within a well-known and multi-facetted biologic and biosimilar solutions services company.

Project Manager

Ideally should be based in Boston

• Experience working closely with start-ups in Gene and Cell Therapy Companies in developing Regulatory, CMC, Clinical and Commercialization Strategies.
• Business Development experience is a must
• Leads the strategy for both pre-clinical and clinical programs in support of 351K submission
• Manages start-up and commercial manufacturing initiatives for multiple Clients
• Provides regulatory and quality to support successful FDA audits
• Should bring process development expertise for new products
• Experience orchestrating the regulatory resources in accordance with established regulatory strategies to support product filing in US and EMEA
• Takes care of workplan & dashboard
• PMP certification is highly desirable
• Required industry experience: Biotechnology or Biosimilars
• Proficiency in MS Project is required.
• 7+ years of leadership management background
• Must be able to present business growth strategies to Top Tier Executives and Board Members.
• Work base location: Boston, MA / Some travel may be required and will be reimbursed

CMC Senior Manager

Ideally should be based in Boston

• We look for a CMC Senior level leader to help with the FDA Inspection readiness
• Must have experience working directly with the FDA
• A proven track record in the delivery of complex biologics RA CMC projects for FDA, EMA, and/or other Global Health Authorities.
• Experience taking a product from concept through to launch including scale-up and transfer to manufacture.
• Experience in complex biologics, vaccines, cell therapy, and/or gene therapy; combination products is a plus.
• Experience defining CMC content (data and documentation) requirements for regulatory submissions and writing/reviewing this content for conformance with established requirements, including GMP and EMA/FDA/ICH/WHO/Global regulations and guidelines.
• Plans, executes, and manages RA CMC components of IND/CTA, including vendor management and writing/review of key module 3, IMPD sections, and related CMC documentation and quality processes.
• 5+ years of direct experience in Global Drug/Biologics development in the biopharmaceutical/biotechnology industry.
• 2+ years of direct experience in Regulatory Affairs CMC position.
• BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.