Product Operations Leader, Executive Director

At ACELYRIN, INC the patient is at the center of our culture and our business. We are guided by our values of courage, compassion, collaboration, innovation, and a sense of urgency. Our key value of courageous caring means putting patients first and having the courage needed to quickly solve challenging issues, we strive to redefine what is possible and quickly bring innovative therapies to bear against serious diseases.

Location: Agoura Hills, or South San Francisco, California (or remote with travel)

Job Title: Product Operations Leader

Reports To: Chief Technical Officer

Function: Tech Operations

Job Type: Full Time

Position Summary:

In this dynamic role you will be responsible for ensuring all CMC aspects of several development programs in various stages are properly planned, resources, and executed. This necessitates highly collaborative leadership as you will be accountable for the Product Operations team within Tech Ops. We are looking for an experienced biopharma leader with strong partnering skills and the ability to work seamlessly within a fast-paced product development, early-stage company. The successful candidate will be a seasoned technical professional with a clear understanding of the CMC requirements to successfully achieve regulatory approval for a new biologic or small molecule. Effective communications skills and a problem-solving mindset combined with a willingness to work both strategically and hands-on will be necessary. As ACELYRIN grows its pipeline, it's become imperative that the individuals we hire be adept at working seamlessly within cross-functional teams that combine internal staff, contractors, consultants, and contract manufacturers to deliver against aggressive development timelines.

Responsibilities:

• Develop and manage the Product Operations function to ensure that all aspects of CMC commercialization are carefully considered cross-functionally within Tech Ops and integrated with our company-wide development strategy.
• Serve as a Product Operations Leader for Tech Ops, leading and managing the Product Technical Operations Team (PTOT) for our lead program.
• Coach and develop the PTOT leaders reporting within your organization.
• Ensure a strong partnership with the Acelyrin Product Teams (PT) and the effective functioning and performance of the Product Technical Operations Team (PTOT) to ensure Commercialization deliverables are met throughout product development.
• Advance and create the tools and processes required to further this critical capability within Tech Ops. Coach and train the Tech Ops organization on these concepts and expectations. Work with Acelyrin's Program Management head and Product Leaders on execution strategies and develop integrated program plans and timelines to ensure successful commercialization milestones.
• Initiate Operations Launch planning process and capabilities in concert with the Commercial organization for our first new product launch. Create a template for early phase PTs and support of Business Development opportunities.
• Support the Operations Leadership team by ensuring all deliverables are achievable, resources, streamlined, and achieved.

Qualifications and Skills Required:

• Basic Qualifications: Doctorate degree & 15 years of Manufacturing & Operations experience OR Master's degree & 20 years of Manufacturing & Operations experience OR Bachelor's degree & 25 years of Manufacturing & Operations experience.

• Preferred Qualifications: Experience in direct leadership roles within Biologics and/or Small Molecule Manufacturing and Quality. Product Operations leadership experience, team membership on product teams, and successful licensure of more than one product.

Essential behaviors and ways of working:

• Commitment to company values and culture
• Ethical, trustworthy, and reliable
• Collaboration and communication across multiple functions
• Team player, open to the ideas of others
• Group facilitation and problem-solving capabilities

ACELYRIN, INC, does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

Candidates will be required to show proof of being fully vaccinated against COVID-19 upon commencing employment. Reasonable accommodations will be considered on a case-by-case basis for exemptions to this requirement in accordance with applicable law.