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.  Remote work arrangement is possible.

Job Title:             Associate Director, Operations & External Manufacturing Project Lead

Reports To:        Senior Director- Project Management CMC

Function:            Technical Operations

Job Type:            Full Time Employee

 

 

Position Summary:

Join and help build our rapidly growing organization!  This is an opportunity to help broaden ACELYRIN, INC. Technical Operations and External Manufacturing organization by leveraging successful strategies from past experiences within a nimble and supportive organization that is open to flexible approaches to solving complex challenges.

 

We are looking for a collaborative, positive, self-driven individual with the ability to work successfully within a hybrid work environment.  The successful candidate will be able to coordinate with technical and business stakeholders, exhibit both leadership and management skills, and have a willingness to work hands-on to achieve ACELYRIN, INC goals.  As ACELYRIN, INC grows, we require individuals who can work seamlessly within cross-functional teams that combine internal staff, contractors, consultants, CDMOs, and other external resources to deliver against aggressive development timelines.

 

If this sounds like an attractive opportunity, we encourage you to apply so we can discuss this further.

 

Responsibilities:

 

·       Manage collaboration and project execution with external contract manufacturing organizations

·       Responsible for contract oversight and budget management of CMOs or other specialty vendors, including purchase orders and invoice setup and tracking

·       Leverages decision analysis tools and develops business cases to support decision making of strategic importance to Technical Operations

·       Key contributor and coordinator of organizational budget development and tracking

·       As a key interface between different groups, ensures timely communication of changes or updates on timelines and deliverables

·       Engage stakeholders, ensures cross-functional alignment, and facilitate internal and external communication

·       Leads cross-functional initiatives that advance ACELYRIN, INC’s Technical Operations and manufacturing capabilities

·       Lead project team members (internal and external) to successful execute on project goals and milestones; facilitates meetings and presentations; generates minutes, etc.

·       Work cross-functionally to develop project timelines to identify key interdependencies and critical path to deliver integrated plans

·       Coordinates and oversees execution of product CMC commercialization strategy throughout the product lifecycle

·       Develops tracking dashboards to communicate project updates and identify any critical issues that can play or impact project

·       Responsible for timely identification of critical path risks and for escalating issues to line leaders and project team representative for resolution

·       Ensures all team members understand project goals and objectives, current project plan and schedule, critical path activities and risks

·       Exercises good judgement within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results

 

Qualifications and Skills Required:

 

·       BS minimum in pharmaceutical science or related field from an accredited college or university, MBA preferred.

·       8+ years of related pharmaceutical, biopharmaceutical industry. (Equivalent combination of experience and education may be considered.)

·       Proven success in project management in the pharmaceutical or biopharmaceutical industry.

·       Advanced MS Project and MS Excel skills required

·       Solid experience in facilitation and project team management with demonstrated excellence in presentation, analytical thinking, problem solving, and organizational improvement

·       Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced and demanding environment

·       Proven success influencing stakeholders and teams in a matrix management environment

·       Strong understanding of pharmaceutical and/or biopharmaceutical manufacturing and development

·       Knowledge of GMP’s, FDA and ICH guidelines, as well as other regulatory requirements relevant to the pharmaceutical industry

·       Experience in a smaller entrepreneurial environment is an asset

·       Good decision-making skills exhibiting strong judgment and effective collaboration across diverse points of view

·       Strong communication skills (e.g., clear and concise), team player, and proven negotiation skills.

·       Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines

 

Essential behaviors and ways of working:

 

• Sets and supports organizational tone in line with ACELYRIN, INC’s culture
• Entrepreneurial mindset and behaviors
• High energy, but respectful and encouraging with internal and external and external peers and staff
• Leadership, respect, encouragement, and motivation in virtual and face-to-face engagements:  effective in-person and remote-work capability
• Collaborative, cross-functional team leader and member while also being an independent, hands-on contributor
• Flexibility to work effectively with all levels of ACELYRIN, INC, our partners, and external collaborators

 

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.