Vice President of Manufacturing (GMP, Biologics)
Vyriad is an early clinical-stage company (Rochester, Minnesota) developing proprietary oncolytic virus therapies for the treatment of cancers with significant unmet needs. Revolutionizing cancer treatment is our long-term goal, requiring curiosity, perseverance, an openness to challenging convention and a commitment to excellence. We are united in our mission, and the goal to improve the quality of life of patients worldwide.
Position Overview and Requirements
The Vice President of Manufacturing is responsible for leading all aspects of Vyriad’s Chemistry Manufacturing and Controls activities, including company strategy and day-to-day operations for drug manufacturing and facility operations of our multiproduct GMP facility. The candidate should have extensive experience in GMP manufacturing of viral vectors, viral vaccines or oncolytic viruses, from early-phase to late-stage clinical or commercial manufacturing. This role will be responsible for ensuring the overall CMC operations success of our entire portfolio of programs by setting overall strategic direction, ensuring that timelines are met, and resources are effectively managed. This position requires deep knowledge of technical and regulatory aspects of viral manufacturing and superb written/verbal communication skills required to support Vyriad’s ongoing interactions with the FDA for their late-stage clinical trials and commercialization timelines.
This position requires strong organizational and leadership skills to coordinate evolving manufacturing timelines and the ability to develop risk-based approaches for the rapid manufacture and release of products. This role leads teams (manufacturing, supply chain, facilities, process development) to produce clinical oncolytic virotherapies (Phase 2 and 3) and pipeline virotherapies for pre-clinical and early-stage clinical testing. Activities will include technology transfers, process development and optimization, development and refinement of manufacturing and quality systems, routine clinical cGMP manufacturing, and eventually commercial manufacturing. The position requires strong communication and partnership with Vyriad’s quality management, scientific, process development, and regulatory teams. The successful candidate will have a demonstrated track record of technical and strategic leadership.
Position Specific Competencies – Performance Expectations:
- Develops and builds the cGMP-manufacturing and process development functions and capability to support late-stage clinical development (Phase 2 and 3) and readiness for commercialization.
- Leads the development of CMC strategies, capabilities for oncolytic virotherapies and execution of Vyriad’s oncolytic virotherapies programs:
- Direction of technical activities for upstream, downstream and formulation development activities to ensure scalable and commercially viable processes are developed.
- Responsible for all aspects of process scale up, technology transfer and GMP manufacturing.
- Ensure process development group best practices that are aligned with current GMPs.
- Responsible for facility management and future expansions.
- Builds, maintains and motivates a multi-technology operations team capable of achieving all productivity targets and output requirements to service customers with product on time.
- Collaborates cross functionally with Quality Assurance and Quality Control areas to plan and implement the execution of cGMP activities in manufacturing operations for both development processes and commercial operations.
- Develops and manages the budget requirements for each fiscal year. Organizes the purchase of appropriate capital items as required for projects.
- Develops and leads a culture of learning, respect and employee growth. Establishes the department’s strategic vision and mentor the manufacturing ops team towards goal achievement.
- Manages the manufacturing operations for drug substance and drug product.
- Oversees manufacturing incidents and investigations, corrective and preventive actions (CAPA), process variances and deviations.
- Ensures completion of manufacturing change controls, CAPAs, and deviations.
- Ensures that facilities are inspection-ready, including staff compliance with cGMP and all related elements such as documentation (standard operating procedures [SOP] and validation protocols etc.), training, reports and records. Develops and executes strategies to prepare for pre-approval inspection/commercial launch.
- Develops short- and long-term goals for the manufacturing efforts in support of regulatory submissions, clinical efforts, and program-driven milestones.
- Effectively recruits, retains, develops and leads a manufacturing team.
- Leads and directs filing activities for regulatory agencies, including assisting quality assurance in representing the site during agency inspections and in the formulation of inspection responses.
- Communicates and escalates operational status regularly.
- Collaborates across functions to drive manufacturing excellence, share best practices and lessons learned.
- Leads by creating a positive environment of open communication and staff development.
- Provides continuous and timely performance feedback to direct reports, including coaching on performance management and professional advancement.
- Provides employee recognitions for accomplishments in a thoughtful and timely manner.
- Delegates work assignments to staff as appropriate, considering employee strengths and expertise to address associated tasks.
- Mentors individuals, based on individual needs, to meet current job expectations and career goals.
- Promotes adaptation and flexibility in a rapidly changing environment. Acts as a change leader through team building and influence. Willingness to make difficult or unpopular decisions when warranted.
Ph.D. or M.S. in Biology, Medicine, Chemistry, Engineering or related field required
- Fifteen (15) years of relevant experience in GMP manufacturing of viral vaccines, gene therapies or oncolytic viruses.
- Ten (10) years of management or supervisory experience and CMC operations and facility oversight.
- Fifteen (15) years of relevant experience virotherapy drug manufacturing to support late-stage clinical testing and commercial launch.
- Experience in managing technical operations and CMC activities and projects with respect to science, technology, quality, and regulatory requirements
Compensation and Benefits
Salary is commensurate with experience and qualifications. A comprehensive benefits package, including:
- Paid Holidays
- Employer paid Short- and Long-Term Disability
- Life Insurance
- Dental Insurance
- Simple IRA with an employer match
Work visa sponsorship is not available for this position.
Exempt. Normal schedule is 8:00 – 5:00 p.m. Monday through Friday with the ability to accommodate complex manufacturing processes that require off-hour work.
How to Apply
Please send a resume and cover letter to firstname.lastname@example.org. References will be requested and background checks will be required prior to start of employment. Applications will be reviewed as received until the position is filled.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Vyriad is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.