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Senior Scientist/Associate Director, Biologics Analytical and Drug Product Sciences

Invetx

Invetx

Product
Boston, MA, USA · Boston, MA, USA
Posted on Thursday, March 14, 2024

Position Summary
Invetx Inc. is a veterinary biotechnology company based in Boston, MA that is engaged in the discovery and development of novel biotherapeutics for veterinary medicine. Using a proprietary platform that combines industry-leading technologies from global partners, several fully species-specific monoclonal antibodies and antibody-based products for veterinary use are being developed for the Animal Health market.

Invetx operates in a combined model of conducting its own laboratory studies primarily in Discovery/Research in the greater Boston area, and outsourcing manufacturing and other activities with global partner organizations. Invetx’s Chemistry, Manufacturing and Controls (CMC) Development and Manufacturing group is responsible for all aspects of product development, including production of clinical trial materials and commercial manufacturing in collaboration with our global partner CDMOs. As our product candidates advance in clinical studies, the company is looking to expand our CMC team to support development and manufacturing efforts, including CMC development activities at our lab.

The Senior Scientist/Associate Director will play a key role in the progression of Invetx’s pipeline candidates and will be responsible for leading CMC development activities in the internal lab, mainly focused on analytical and drug product aspects, contract CMC process, formulation, and analytical method development activities, and building a CRO network for supporting CMC development activities. Working in collaboration with Invetx team members including the CMC Operations team lead as well as our external partners in the planning and oversight of CMC development activities is a key aspect of the role.

This position offers an opportunity to apply your experience and skills across all aspects of process, formulation and analytical method development, and project management of CMC development activities. The Senior Scientist/Associate Director will be a key member of the CMC leadership team of Invetx and will help build the CMC systems and network for development necessary to support the growth of the company toward pivotal phase clinical studies and commercial product launch.

Key Objectives

  • Oversee laboratory studies to perform technical evaluation of antibody-based product formulations, drug product development and analytical characterization.
  • Support review of CMC technical development documents focused on bioprocess, drug product and analytical method development and qualification reports.
  • Work in close collaboration with Discovery group members in developability and selection of molecule candidates.
  • Support the systematic progression of CMC development projects from the proposal stage through project completion collaborating with internal team and CDMOs.
  • Monitor and troubleshoot key outsourced development activities. Provide technical support during site visits and support quality audits as required.
  • Support implementation of reliable strategy for process and product development for FDA/EMA and USDA-regulated products using external CROs and CDMOs.
  • Support negotiation of product development and characterization agreements with CDMOs/CROs for the Invetx product portfolio.
  • Collaborate with other CMC members and cross-functional groups to ensure successful execution of various CMC projects, and delivery of results on time and within budget.
  • Assist with CMC development alliance management and product development strategy. Serve as a liaison and streamline current interactions with external partners.
  • Coordinate with legal, technical and development teams to establish nondisclosure agreements, service terms and conditions, and quality agreements. Review and facilitate approval of proposals, work orders, and changes.
  • Represent Invetx in a consistent highly professional manner with integrity, respect, determination and in an ethical manner. Foster a team culture of collaboration, communication, ownership, and accountability.

Position Requirements:

Education and Experience

  • Bachelor, Master, or PhD in Life Sciences, Pharmaceutical Sciences, Bioprocess or Chemical Engineering, or related science.
  • Ideal candidate will have 9+ years of experience in the biotechnology industry with significant experience in bioprocess, formulation and/or analytical control strategy development and some exposure to GMP manufacturing of biologics, and experience with global contract manufacturing networks and 3rd party relationships for process and product development.
  • Good working knowledge of biopharmaceutical process development including biologics (mAB) Drug Substance and Drug Product process development, and analytical development/quality control.
  • Candidate should possess strong and effective project management, problem solving and interpersonal skills and have a proven track record working cross-functionally across a wide variety of technical, business, and operational areas.
  • Working knowledge and understanding of current regulations and industry trends for large molecule product development, analytical characterization and testing is preferred.
  • Knowledge of the animal health industry regulatory guidelines for CMC under FDA, EMA and USDA and other regulatory agencies would be an advantage.
  • Experience in negotiating and executing process and product development activities as well as supply contracts and quality agreements will be an advantage.

Skills and Personal Attributes

  • The ideal candidate is preferably based in the Boston area to lead lab-based CMC activities and comfortable working in a virtual project team environment.
  • Excellent cross-functional collaboration skills with proven ability to build and maintain strong and sustainable relationships with cross-functional, cross-cultural project teams, internal and external customers, and business partners.
  • Self-motivated, able to work with limited guidance, both alone and as a member of a team.
  • High level of proficiency in verbal and written communication, use of digital tools(videoconferencing, MS Office and other software, project management tools, databases).
  • Passionate about animal-health and getting innovative veterinary medicines to market.
  • Ability to travel (domestic/international) approximately 10-15%.
  • Excellent people management skills with the ability to develop effective relationships, motivate others and influence in a cross-functional environment.
  • Requires flexible work schedule to some extent to accommodate international activities.
  • Able to influence and work well with others in a proactive and constructive manner.
  • An independent self-starter with the ability to resolve supplier performance challenges and implement process and/or system improvements.

Position summary

Position Senior Scientist/Associate Director, CMC Development
Reports to position Senior VP of CMC Development and Manufacturing
Group CMC Development & Manufacturing
Location Boston (Hybrid model)
Employment type Full time
Travel requirement
  • Travel to manufacturing sites likely in the US, EU and/or China, regulatory agencies, partner CROs/CDMOs, Invetx office (Boston, MA), meetings and events, and other locations as required. Travel will be domestic (US) but international travel may also be required
  • Varies but approximately 10-15% of time
Managerial responsibility
  • Support CMC development activities
  • Potential for the group to grow as the portfolio develops
Key relationships Internal
  • CMC Operations lead.
  • Senior VP, CMC development and manufacturing
  • CEO
  • Chief Development Officer
  • Clinical and Regulatory Group team members
  • Invetx staff and partners in Discovery, Program Management, Quality and in business-support areas

External

  • CDMOs and CROs
  • Consultants supporting internal functions e.g. Regulatory CMC, QA
  • Academic experts and KOLs in areas of interest.