Are you looking for a company driven by innovation and passion for saving lives that will inspire you and empower you to challenge yourself every day?
At The Discovery Labs Center for Breakthrough Medicines, we are building an unprecedented enterprise that brings together the necessary capabilities, infrastructure, and world-class leaders to facilitate the development and manufacturing of cell and gene therapies from bench to bedside.
The Discovery Labs Center for Breakthrough Medicines aims to be the leading global provider of world-class cGMP manufacturing, turnkey laboratory solutions, critical materials, and office space that support therapeutic products and services to the biotechnology and pharmaceutical industry. Our mission is to help accelerate the delivery and affordability of life-changing therapies to those who so desperately need them. Through seamless access to the development and manufacturing capabilities required to launch innovative cell and gene therapies, The Discovery Labs Center for Breakthrough Medicines can deliver the therapies needed to save countless lives. Our gene therapy resources and manufacturing technologies address the full spectrum of service needs from early-stage innovation through commercial launch.
The Discovery Labs Center for Breakthrough Medicines is looking for a Head of Viral Vector and Plasmid Process Development to lead our highly innovative team and add significant value to the organization.
Job Summary: The Head of Process Development has overall responsibility for guiding the development of pre-clinical, clinical, and commercial production processes for Viral Vector and Plasmid products. Including but not limited to raw materials related to the production of these products, process development and optimization, manufacturability assessments. As the lead of the PD asset , this includes leading a team of scientists that are implementing the latest technologies and best-in-class development approaches to increase yield, ensure scalability and quality, and meet accelerated timelines for clients. This includes oversight and management of new product introductions as well as technology transfer into manufacturing. Developing Life Cycle strategies and plans, including clinical and commercial phases, process improvements and post approval commitments. The individual will be accountable for the successful execution of the corresponding plans in collaboration with the clients, on timeline and budget, and in compliance with Agency and Industry Guidance.
Lead and oversee specified process transfers to and from internal and external business partners.
Own and execute Quality by Design (QbD) for programs in collaboration with the Quality Unit.
Leverage all of The Center for Breakthrough Medicine’s process development expertise to support programs.
Responsible for the development schedule and adhering to appropriate level of documentation, budget, schedule, and safety commitments.
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.
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 cell and gene therapies.
Make decisions, based on the professional judgment, experience, budget, future cGMP considerations, 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.
Evaluate the functional strengths and developmental areas in the Process Development team and drive a culture of continuous improvement.
Manage team of senior managers and professionals within Process Development. Hire and develop employees within the department in support of site objectives. Assigns work, provides feedback and coaching, and takes necessary disciplinary actions.
Work with internal stakeholders in manufacturing, process development & optimization, project management etc. to facilitate successful customer management.
Independently review the design, execution, data and reporting on the development work completed within the Process Development group. Is expected to resolve (or have resolved) all technical issues.
Key input into the development of manufacturing platforms and novel technologies.
Experience and Qualifications:
Ph.D. in biochemical engineering or biological sciences with 15-20 years experience required.
Solid foundation in the fundamentals of biochemical engineering and Virology.
Entrepreneurial experience dealing with customers in product development.
Working knowledge of cGMPs related to the production of biologics, specifically advanced therapeutics (cell and gene).
A combined ten to fifteen years of development and scale-up experience in upstream and downstream processes.
Experience with suspension and adherent bioreactor-based production processes and chromatography-based downstream process.
Experience with a variety of production platforms for viral vector manufacturing (i.e. baculovirus, transient, microcarriers).
Experience in the development of Plasmid production.
Experience in DoE, process characterization, and associated statistical analysis.
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.
THis is a client facing role as our ambition is to become a world renowned leading CDMO in the Cell and Gene Manufacturing Space.