Director, Technical Operations - Analytical Sciences

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, CA or South San Francisco, CA
Job Title: Director, Technical Operations - Analytical Sciences
Reports To: Executive Director, Technical Operations - Analytical and Product Quality Sciences
Function: Technical Operations
Job Type: Full Time Employee
Position Summary:
ACELYRIN is looking for a collaborative, positive, and motivated individual with the ability to work independently within a hybrid work environment. The successful candidate will exhibit strong technical expertise, leadership and management skills, oral and written communication skills, and a willingness to work both strategically and hands-on to achieve ACELYRIN goals. As ACELYRIN 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.
The Director, Technical Operations - Analytical Sciences will function as the Analytical Sciences lead for one or more of ACELYRIN's clinical products. This individual will be responsible for establishing analytical capabilities to support phase appropriate control strategies at contract manufacturers and testing laboratories. This individual will also lead the design and execution of the product characterization strategy, contribute to the design and justification of the product control strategy, and the development and execution of analytical comparability studies. The successful candidate will also be able to effectively communicate across ACELYRIN functions, with partner organizations, and to the relevant regulatory authorities.
The Director, Technical Operations - Analytical Sciences position is an excellent opportunity to practice existing expertise while expanding your skills in new and exciting ways. We encourage you to apply if this sounds like an attractive opportunity.
Responsibilities:

• Function as the analytical lead on the Technical Operations team for one or more clinical products
• Responsible for the implementation, qualification, validation, transfer, and remediation of analytical methods
• Directly engage and manage CDMO and contract testing laboratories to formulate plans and advance analytical aspects of projects
• Design and manage phase appropriate product characterization studies
• Contribute to the development of phase appropriate control strategies, including in-process control, lot release, and stability testing
• Participate in the development of drug substance and drug product analytical comparability strategy; support execution of comparability studies and interpretation of results
• Contribute to the qualification and maintenance of product reference standards
• Ensure the availability of analytical method critical reagents, including the selection of suppliers
• Lead or contribute to product investigations
• Participate in program risk management, including product or process risk assessments
• Support OOS, OOT, and Quality deviation investigations as well as change control activities
• Author regulatory filing sections and respond to regulatory agency requests for information
• Interact directly with regulatory authorities through site inspections, teleconferences, or face-to-face meetings
• As ACELYRIN builds out its portfolio, this position may require line management responsibilities

Qualifications and Skills Required:

• 10+ years of relevant Analytical Sciences experience in the biopharmaceutical industry
• Ph.D. in a related scientific discipline is preferred
• Proven track record of accomplishments in biologics Analytical Sciences, product quality, or process development organizations
• Past experience as primary author of relevant sections of clinical and commercial regulatory submissions, e.g. INDs and BLAs
• Experience interacting with global regulatory authorities in support of inspections and review activities (face-to-face, teleconference, written)
• Experience with clinical and commercial technology transfers as the analytical or product quality lead

• Knowledge of GMPs, FDA and ICH guidelines, as well as other regulatory requirements relevant to the pharmaceutical industry

• Ability to travel internationally to CMOs or contract laboratories as needed for face-to-face engagement and troubleshooting
• Able to work independently and complete projects with minimal oversight, escalating issues to management with discretion
• Motivated and results-oriented individual with outstanding work ethic, able to perform in a fast-paced environment
• Ability to multi-task and adjust priorities quickly while working under tight deadlines
• Strong oral and written communicator with concomitant interpersonal skills

Essential behaviors and ways of working:

• Sets and supports organizational tone in line with ACELYRIN culture
• Entrepreneurial mindset and behaviors
• High energy, but respectful and encouraging with internal 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
• Ability to work effectively with all levels of ACELYRIN, 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.