We are seeking a Head of Process Development who will report directly to the Head of Process Science.
The Head of Process Development will be responsible for the development of manufacturing processes and analytical methods for the production of cell and gene therapy products including viral vectors. The ideal candidate will have extensive managerial and leadership experience with supervising and providing guidance to a large group of highly technical and scientific group of subject matter experts. The successful candidate should have a good understanding of technical challenges and potential solutions for development of clinical and commercial viral vector manufacturing processes for cell and gene therapy applications.
In this newly created role, you’ll be called upon to offer both scientific and management guidance in the design and execution of new or unique cell and gene therapy projects. You’ll bring experience in managing team resources to assist in establishing systems and departmental guidelines, ensuring close collaboration between process development and assay/analytical method development teams, supporting cross -training and seamless delivery of department goals. You’ll be seen as a role model to support strong positive collaboration and relationships with Manufacturing (MFG), Quality Control (QC), Material Science and Technology (MSAT), Project Management (PM) and other departments as well as externally in the biotech network. You will be a valued resource as the technical subject matter expert (SME) in client meetings and regulatory audits, supporting proposal development for existing and prospective clients in conjunction with the Sales and Business Development teams.
- Builds and leads a team of managers, scientists and research associates focused on the development of viral vector manufacturing processes and analytical methods for cell and gene therapy applications
- Hires top talent and provides coaching, mentoring and development to each member of the Process development team both in execution of their group responsibilities and in their own personal development
- Owns the development life cycle for multiple projects in parallel. Understands process development based on good manufacturing practice (GMP) design considerations and at-scale cGMP manufacturing process for clinical and commercial manufacturing
- Provides technical direction and manages technical risks throughout the development and technology transfer process ensuring successful program management and delivery
- Drives scope definition and experimental design of process development and analytical methods activities through respective project leaders; aligns goals of the projects with overall project plans including process development, tech transfer to QC and manufacturing; obtains buy-in from client and removes obstacles to successful completion
- Establishes and executes the detailed development project plan including process and assay transfer, development or optimization, process characterization, assay qualification, assay validation and tech transfer of process to MSAT and assays to QC. By working with the Program manager (PM), engages in supporting other functional groups and departments proactively, and effectively manages changes to scope and timeline. Actively drives alignment with PM, QC, and MFG on development targets to ensure appropriate process and assay fits, and succeeds in manufacturing and release testing
- Aligns with global development strategies and keeps the global development department management updated on progress, risks and challenges, and serves as liaison between development staff and other departments
- Manages department resources using established systems and ensures close collaboration between PD and bio-assay managers and supervisors to support cross-training, dynamic resource management and seamless delivery of department goals
- Serves as technical SME in client meetings, regulatory audits; supports proposal development for existing and prospective clients in conjunction with sales and business development colleagues
- Develops and mentors direct reports through challenging assignments and by providing constructive feedback. Sets and cascades realistic goals and monitors performance on an on-going basis (via formal and informal channels), to ensure that overall project goals are on track
- Continually seeks opportunities to improve client satisfaction while keeping Vibalogics’ interests in clear focus
- Supervises development labs directly or through team to ensure that they are fully capable, operationally efficient and safe. Pays specific attention to cleaning, safety, 5S and EPS compliance.
- Proactively and independently works with other managers and department heads to resolve conflicts or gain alignment prior to escalation
- Maintains constant emphasis on safety and ensures a safe working environment for self and others
- Owns and drives the implementation and harmonization of standard development activities of global PD and bio-assay initiatives
- Identifies and escalates development risks to executive management
- Prepares project progress summaries appropriate for management/client review. Prepares and/or reviews development team presentations, bio-assay protocols and reports and provides constructive feedback to address the gaps and risks
- Develops and implements departmental SOPs, DMRs, labels, PQA documents, written materials
- Develops strong connections within the Vibalogics network, contributes proactively to global projects and is known as an industry expert in area of specialty
Key skills and experience:
- Master’s degree or PhD in a life science discipline with extensive experience with analytical method development for cell and gene therapy related topics.
- Multiple years of previous supervisory experience with strong leadership and interpersonal skills
- Extensive research experience with development of viral vector manufacturing process including upstream, downstream and analytical methods implementation
- Solid knowledge and understanding of current cell and gene therapy applications, challenges, and strong desire and expertise in developing new innovative technologies to address those challenges
- Substantial interest in preparing service proposals for potential customers and managing a service portfolio
- Experience in working with clients and managing customer projects
- Strong track record of translating new product ideas into project plans and executing them by assigning resources as well as tracking project progress toward milestones and deadlines
- Displays a clear willingness to listen to others
- Has good interpersonal skills and works collaboratively in an effective manner to achieve objectives
- Proven ability to inspire and motivate a large team in the achievement of specific objectives
- Able to effectively work cross culturally
- Occasional travel domestically and internationally may be required
Vibalogics US, Inc. offers a very competitive benefits package including medical, dental, vision, prescription drug coverage, life and disability insurance, 401(k), and generous vacation and time off policies among other attractive benefits. We operate in a world class facility to attract the best and brightest talent to work collaboratively in our mission to bring novel therapies to the patients who need them most.
To apply: please forward a resume to: Linda.firstname.lastname@example.org
Vibalogics, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age status as a qualified individual with a disability, protected veteran status, or any other characteristic protected by law.