Senior Vice President, Global Manufacturing Operations
Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.
At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.
Our vision: Pioneering science to create transformative molecular medicines.
Our mission: Lead innovative science and drive clinical outcomes to transform people’s lives.
- Advance innovative science by pushing boundaries.
- Bring transformative therapeutics to patients in need.
- Provide an environment for employees to reach their fullest potential.
- Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
- Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
- Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
- Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
- Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.
We have an opportunity for a Senior Vice President, Global Manufacturing Operations to join the AskBio team and be part of our continued success!
The Senior Vice President, Global Manufacturing Operations, reporting to the Chief Technology Officer, will be responsible for overseeing and leading the manufacturing operations function to ensure the company is prepared to transition its programs from clinical manufacturing to commercial manufacturing. This position will be responsible for providing strategic direction and growth of the company necessary to achieve regulatory approval and commercial manufacture of many gene therapy programs in AskBio’s pipeline. The ideal candidate will be able to provide oversight for manufacturing of complex biologic and synthetic manufacturing systems and ensure that all systems and processes are validated and consistent with regulatory requirements. This role can be located in RTP, North Carolina, Philadelphia, Pennsylvania, and Boston, Massachusetts. Occasional domestic and international travel may be required.
- Develop a plan to deliver CMC components from multiple programs and preparation for a commercial launch including validation of existing Viralgen manufacturing facility, validation of the company’s manufacturing process, validation of analytical procedures and preparation of CMC documentation for BLA submission.
- Establish CMC Regulatory Strategy in partnership with the heads of Process development, Analytical development and Regulatory CMC.
- Build, lead, manage and develop a best-in-class, high-performance manufacturing operations organization.
- Provide effective leadership to the team and related support functions to ensure the development of the business and its people.
- Manage the organization to accommodate anticipated growth and to ensure bench strength across all levels and organizations.
- Responsible for building, leading and overseeing various manufacturing operations functions as well as Phase III and commercial manufacturing in collaboration with TAAV and Viralgen.
- Establish commercial supply chain plans for products including the management and oversight of external vendors.
- Provide leadership in the validation of the AskBio’s commercial manufacturing facility.
- Coordinate the late-stage process development process and manufacturing teams at both AskBio and Viralgen in order to ensure appropriate methodologies, processes and systems are in place.
- Define transfer strategies which enable process validation and commercial manufacturing.
- Lead continuous improvement initiatives throughout the product lifecycle.
- Collaborate with regulatory to define the appropriate regulatory and validation strategies to support post-approval changes.
- Responsible for leading high impact cross functional initiatives.
- Provide strategic input to the commercialization of new products.
- Set the strategic direction of the manufacturing operations group and coordinate any interactions with third-party contractors.
- Develop a strategy to minimize commercialization risks while building strong relationships with key stakeholders.
- Oversee the design and conduct of complex troubleshooting activities associated with commercial manufacturing.
- Oversee the design and execution of project planning and project management systems.
- Develop timelines, resource requirements and evaluate financials for manufacturing processes.
- Provide management and technology leadership to the manufacturing organization including, equipment requirements, technology transfer, manufacturing documentation requirements, facilities and manufacturing operations.
Required Education and Experience
- M.S. or Ph.D. in chemical engineering, microbiology, biology or other related discipline.
- 15+ years’ experience in technical operations, technology transfer, clinical manufacturing, process development, or manufacturing in a biologics or vaccines environment.
- Demonstrated track record of leading facility and process validation through approval of at least two biological products or vaccines.
- Extensive CMC regulatory experience, validation experience and experience in the preparation and submission of BLA’s for at least two biological products.
- Experience in supporting global filings and a successful track record in completing pre-approval and post licensure inspections in US, EU and Canada required. Japan, Australia and other global countries a plus.
- Experience overseeing, building out and validating a new biologic manufacturing facility
- Experience working with contract manufacturing organizations, vendors and partners as appropriate
- Experience leading the establishment of a commercial supply chain in support of a new product launch of a biological product
Preferred Experience and Skills
- Detailed knowledge of cGMP, GLP and process validation.
- Entrepreneurial and strategic builder rather than a “steady state” manager.
- Creativity in problem identification and resolution and a relentless, hands-on drive to implement and accomplish company goals and objectives in a rapid-paced, changing business environment.
- Ability to lead by example, attract and develop talent, build interdependent partnerships and create a culture of collaboration and teamwork that fosters open communication, constructive conflict resolution and organizational flexibility.
- Strong executive presence, focus and drive to succeed—confidence, passion and high energy.
- Exceptional communication and influencing skills with the ability and personal style to inspire confidence and work successfully with varied audiences including the Board of Directors, current and potential industry partners, key opinion leaders and the management team.
- Ability to plan, prioritize, and execute multiple projects; ability to multitask and work both independently and with cross-functional teams.
- Strong attention to detail and ability to collaborate and work in a team environment.
- Excellent oral and written communication skills including interpersonal skills with the ability to interact effectively with teams, internally and externally.
- Proficient ability to use Microsoft Office Suite (Word, Excel, PowerPoint).
Asklepios BioPharmaceutical, Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or emailing us at firstname.lastname@example.org.