We are seeking a Head of Process Science reporting to the CEO.
The Head of Process Sciences (PS) will be responsible for the development of manufacturing processes and analytical methods for the production or cell and gene therapy products including viral vectors. This person directs the planning, execution and reporting of all process and analytical development activities for Vibalogics in Boxborough. He/She is a scientific leader in viral process development of biologics and its application in the manufacture of Viral Vaccines and Viral Vectors. The Head of PS oversees all customer projects from initial transfer/development to approval of GMP records for execution. He/She is responsible for all aspects of developing robust, scalable and efficient manufacturing processes. The Head of PS reports to the CEO and is a member of the executive team. He/She is responsible for Process Sciences budget and partners closely with the Corporate Controller.
Your key responsibilities:
- Build, manage and lead a world-class Process Sciences team that is technically strong, client focused, innovative and adherent to the highest quality and regulatory standards without compromise to focus on the development of viral vector manufacturing process and analytical methods for cell and gene therapy applications
- Continuously optimize existing manufacturing technologies as well as survey emerging engineering and technology approaches that may offer significant advantages over current methods
- Maintain constant emphasis on safety and ensures a safe working environment for self and others
- Own the development life cycle for multiple projects in parallel, for multiple clients. Understands process development based on good manufacturing practice (GMP) design considerations and at-scale cGMP manufacturing process for clinical and commercial manufacturing
- The incumbent will be responsible for building and directing the organization that designs and develops manufacturing processes and the control strategies to ensure robust, reliable and scalable clinical and commercial viral manufacturing processes 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. Working with the Program Manager (PM), engages in supporting other functional groups and departments proactively and manages changes to scope and timeline effectively.
- Actively drives alignment with PM, QC and manufacturing on development targets to ensure appropriate process and assay fits and succeeds in manufacturing and release testing
- Create client IP in Viral vaccine technology.
- Responsible for the development schedule adhering to appropriate level of documentation, budget, schedule, and safety commitments.
- Interact as appropriate with the company’s site leaders in Cuxhaven, Germany
- Establish and optimize the department fixed cost, variable cost and capital budgets striving to have the Development activities contribute to Vibalogics profitability. Report against and justify variances.
- Support the commercial function in the assessment of new opportunities and provide appropriate Technical and programmatic input to prospective customers, including the demonstration of capability at customer visits.
- Align with global development strategies and keep the global development team updated on progress, risks and challenges and serves as a liaison between department staff and other departments
- Build, hire and develop a team of PhD & non-PhD staff that has the capability to design, plan, and execute experiments to develop and understand processes for production of therapeutic proteins
- Make decisions, based on the professional judgment, experience, budget, cGMP regulations, and the ethical guidelines of good business practices.
- Proactively develop and sustain strong relationships with current customer accounts and contractual services suppliers to the unit.
- Serve as technical SME in client meetings, regulatory audits Support proposal development for existing and prospective clients in conjunction with sales and business development
- Evaluate the functional strengths and developmental areas in the Process Sciences team and focus on continuous improvement.
- Manage a team of senior managers and professionals within Process Sciences. Hire and develop employees within the department in support of site objectives. Assign work, provide feedback and coaching, and take necessary disciplinary actions.
- Work with internal stakeholders in manufacturing, process development, project management etc. to facilitate successful customer management.
- Independently review the design, execution, data and reporting on the development work completed within the Process Sciences. Is expected to resolve (or have resolved) all technical issues.
- Must remain current with relevant technologies and forward thinking to identify new approaches
- Outstanding leadership abilities with demonstrated analytical and critical thinking skills, combined with team management abilities to establish and maintain high-functioning teams
- Executive presence with strong interpersonal and communication skills, verbal and written
- Ability to operate seamlessly in a global environment
- Excellent analytical skills with the proven ability to solve complex problems
- Visionary leadership skills and the ability to interact with all levels
- Proven leader, delegator and decision maker
- Strong financial acumen
Knowledge, skills and experience:
- Masters degree at a minimum. Prefer a Ph.D. in chemical or biochemical engineering, or related discipline with a minimum of 15 years of experience required. Experience with viral-based therapy modalities required
- Multiple years of supervisory experience with strong leadership and interpersonal skills
- Entrepreneurial experience dealing with customers in product development.
- Working knowledge of cGMPs related to the production of viral-based therapeutics.
- Ten to fifteen years of development, tech transfer and scale-up experience.
- Experience with oncolytic virus, and/or viral vector gene therapy and viral vector vaccine upstream and downstream processing are essential. Working knowledge and experience in the following platforms are a strong plus: Suspension based, Adherent based and Egg-based
- Direct experience in viral manufacturing methodologies for both drug substance and drug product.
- Previous experience directing a world-class Process Development or MSAT organization
- Ability to work by influencing peers and their reports and gain their cooperation in dealing with multiple priorities in the delivery of projects.
- Strategic leadership and conceptual thinking to ensure that a cost-effective organization is put in place and developed.
- Rational persuasion particularly in the discussions with customers.
- Strong people management and organizational skills; ability to prioritize and manage through complex processes/projects.
- Ability to interpret and manipulate data, define problems, establish facts, draw valid conclusions and make decisions.
- Ability to deal with abstract and concrete variables in situations where only limited standardization exists.
- Extremely high levels of initiative and tenacity.
- Excellent oral and written communication skills.
- Ability to function in a rapidly changing environment & handle multiple priorities.
- A flexible work schedule is required.
- Some travel may be required both domestically and internationally
- This role is based in Boxborough, MA.
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.