Senior Director, Viral Vaccine Process Development

The Opportunity

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.

Reporting to the Executive Director of Bioprocess Development, you will be a primary member of the Biopharmaceutical product development team and is accountable for scientific and technical leadership of a team of scientists and engineers responsible for process development including cell culture, purification, virology and drug product. The scope includes improving existing processes and developing next-generation processes. The Sr. Director, Vaccine Process and Product Development will also be an important contributor to define and lead process development strategy, oversee functional laboratory activities, and develop a technical team.

Process and Product Development:

• Lead multifunction team and collaborate with partner functions (i.e. Research, Analytical Development, Manufacturing Science & Technology, Engineering, Manufacturing, Quality, Validation, Regulatory) to support viral vaccine process, product development strategy and implementation in manufacturing
• Develop and implement the process development strategy as the leader and technical expert for cell culture-based viral vaccine processes with a focus on productivity (i.e. yield), process capability (i.e. robust impurity control), scalability and economic viability
• Design processes in collaboration with academic and biotech partners; partner with them in the successful project execution
• Direct and integrate development projects across departments (cell culture, purification, virology, drug product) to deliver program goals
• Contribute to CMC sections of regulatory license documents (e.g. IND, BLA)
• Identify innovation opportunities in cell culture, purification, virology, and drug product formulation to enhance bioprocess development projects
• Identify collaboration opportunities and provide technical oversight of product and process development activities sub-contracted to 3rd party development and manufacturing organizations
• Represent TD on R&D and Operations leadership teams to provide program oversight, define strategy, and adherence to project plans
• Promote the reputation of the organization as a leader in the vaccine development field through publication and contributions to larger industry consortia

People Management:

• Lead technical staff for vaccine process development
• Foster a customer-focused culture of innovation and learning, empowerment, diversity, inclusion and trust.
• Identify talent, recruit and manage an experienced team of scientists, managers and process engineers in cell culture, purification, virology, drug product development
• Responsible for program level leadership within the CSL Bioprocess Development (BPD) organization as part of CSL R&D, and in project teams by partnering with R&D functions including CMC, technical transfer and project management
• Promote culture of safety with focus on biosafety, ensures team follows requirements, and implements improvements
• Develop multifunction team strategy and structure, recruit personnel, and build capability to meet process and product development program goals
• Develop multifunction laboratory infrastructure strategy including facilities and equipment, and implements new technology to meet process and product development program goals
• Maintain a state of compliance for team and self through regular review of training and implementing training curricula improvements
• Provide ongoing performance feedback, technical guidance and mentorship to FCC process development team

Operations/Quality Support:

• Partner with Operations to transfer processes into manufacturing, and provides technical support during tech transfer and validation (i.e. process performance qualification) activities
• Use experience in bioprocess development to provide technical support for production of drug substance and drug product in GMP manufacturing
• Use scientific and statistical knowledge to support product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require TD support
• Produce high quality technical presentations for internal audiences including senior leadership to update on program technical progress

• Postgraduate degree (preferably PhD) and experience in relevant industry or academic environment – scientific and people leadership
• Minimum 10 years' experience in biological drug discovery or development
• Broad technical expertise in bioprocess design and development including cell culture and protein purification unit operations, ideally for production of viral vaccines
• Experience managing teams of individual technical contributors (i.e. scientists, engineers) and direct reporting personnel in leadership roles (i.e. manager of managers) across multiple disciplines to deliver complex projects
• Lead and motivate a team of direct reports, build on strengths, and address areas for improvement.
• Record of building mutually-respectful relationships across global regions and companies to foster communication and achieve strategic goals
• Influence at all levels of the organization and manage projects across businesses and the globe.
• Demonstrated people and program management skills
• Present complex technical topics to different audiences with varying technical depth
• Experience demonstrating collaboration and influencing skills across the organization at all levels
• Demonstrated experience establishing and building a team through recruiting and personnel development
• Experience preparing operational budgets

Benefits: Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.