Vice President/Head, Pharmaceutical Development

  • Location:Cambridge, MA
  • Department:Pharmaceutical Development
  • Type:Full Time
  • Min. Experience:Senior Executive

 

      Covid- 19 Mandatory Vaccination Requirement

      Throughout the pandemic, we’ve done all that we can to keep our employees safe, and the employees coming in have been careful to take precautions to reduce the risk of bringing Covid into our work environment. As we reopen our office, we’re mindful that the pandemic is not yet over, and young children are not yet vaccinated. We are committed to continuing to protect our team and keep our office safe.  Vaccination has proven to be the best thing you can do to protect yourself, your family, your colleagues and your community. Since we are striving for a 100% vaccinated workplace (including employees, contractors, vendors and guests), all NEW HIRES will be required to be fully vaccinated, and to present proof of their Covid-19 vaccination to our HR team as part of our on-boarding process.

       

      SUMMARY

      We are currently seeking a Vice President of Pharmaceutical Development to lead the CMC/Pharmaceutical Development group. This individual will work closely and collaboratively with all internal functions and externally with Contract Manufacturing Organizations (CMO’s) to lead Drug substance (DS) and Drug Product (DP) biologics manufacturing, bioanalysis, and formulations for our clinical and pre-clinical programs. This position is critical for overseeing optimized DS and DP processes for our late-phase clinical assets as well as provide essential oversight for existing and future pre-clinical programs. The candidate will have excellent management skills, work co-operatively with others in a dynamic fast-paced environment, and have a genuine desire to be a part of a team that contributes at a high level to organizational and project team goals.

       

      RESPONSIBILITIES:

      • Direction and oversight of all aspects of CMC including development and implementation of strategy for all programs in various stages of development
      • Oversees outsourced CMC functions including cell culture, scale-up manufacturing, protein purification and chromatography, analytical method development and qualifications, formulation development, cell line development, DS and DP comparability strategies, global shipping trade compliance and logistics, and stability testing
      • Reviews CMC project plans and execution, timelines, and budgets; assist in execution to ensure all projects are appropriately prioritized and key goals are met on time
      • Identify, selects, and manages CMO and CRO vendors, including assistance or oversight on due diligence efforts, audits, site visits, and person in plant for critical manufacturing campaigns
      • Responsible for recruiting, developing, training, and retaining the Pharmaceutical Development team.  Ensures prioritization of activities and resourcing is in line with corporate objectives. Fosters a collaborative, highly integrated culture.
      • Effectively works within the Product Development Teams with cross-functional team leaders to achieve corporate and program goals
      • Works closely with Research, Project Teams, Clinical Supply Operations, Finance, Regulatory Affairs and Quality
      • Leads and oversees SOPs, Protocols/Reports for Pharmaceutical Development and Manufacturing activities, CMC Global Shipping and Logistics Activities, CMC regulatory documents and appropriate quality and risk management 
      • Understands and efficiently communicates project status and risks, presents data and strategies
      • Establishes and applies phase appropriate DS, DP and Analytical CMC development concepts and standards in a resource responsible manner
      • Identifies and promotes opportunities to further streamline CMC development activities across relevant interfaces
      • Drives the incorporation of knowledge of current regulations, guidance and competitive environment into decisions and strategy 
      • Collaborates and builds strong internal network with DMPK, discovery and clinical teams to enable knowledge and data integration to guide selection of drug candidates

      REQUIREMENTS/QUALIFICATIONS:

      • A PhD in pertinent life sciences or equivalent is required
      • 20+ years relevant industry experience, preferably with both biotechnology and pharmaceutical companies
      • Understands quality control cGMP production aspects
      • Proven experience with leading, developing and optimizing manufacturing processes and oversight of manufacturing campaigns for supplies ranging from GLP toxicology supplies to cGMP Phase 3 clinical trial material
      • Ability to work in a matrix environment on interdisciplinary teams
      • Experience in a cross-functional, global environment, where interactions with other, equally talented individuals requires technical expertise, negotiating skills and diplomacy
      • Excellent understanding of both scientific and regulatory requirements related to pharmaceutical development, manufacturing and specifications is required
      • Contribute to maintaining an environment that fosters curiosity and taking risks, openness to new approaches, creativity, and opportunistic thinking.
      • Efficient time management, excellent management, organizational, writing, communication and problem-solving skills, and a high degree of flexibility