Associate Director, Device and Packaging Engineering

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:             South San Francisco, CA, or Agoura Hills, CA or Remote

Job Title:             Associate Director, Device and Packaging Engineering

Reports To:         Director - Device and Packaging Engineering

Function:            Technical Operations

Job Type:            Full Time

Position Summary:

Join our rapidly growing organization as an early member of the ACELYRIN Device & Packaging Engineering organization!  This is an opportunity to help build this critical capability for ACELYRIN by leveraging successful strategies from past experiences within a nimble and supportive organization that is open to flexible approaches to solving complex challenges.

Seeking a highly motivated, collaborative, self-driven, and experienced individual with the ability to work seamlessly within a hybrid work environment with extensive experience in device and combination product development and commercialization to provide technical leadership to ACELYRIN’s device and combination product development project and commercial manufacturing activities.  The ideal candidate will also have experience in systems engineering strategies for developing combination products as well as packaging engineering background since the incumbent’s remit will include technical activities related to device design development for the device, secondary packaging, shippers, palletizing, etc.  This position plays an integral role working with cross functional team members and contract organizations to define and execute the device and packaging strategies for all programs.  This individual will also be responsible for ensuring all Design Control elements are satisfied and fully compliant with applicable regulations.

The successful candidate will exhibit strong technical expertise, leadership and management 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.

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

Responsibilities:

• Program lead for all technical activities related to device design and relevant packaging, acting as the Device and Packaging Engineer on cross-functional Technical Operations project teams

• Successfully implement across manufacturing, assemblers, label and pack sites, and suppliers including product transfer/design transfer activities for clinical and commercial products
  • Note:  ACELYRIN operates an external manufacturing network
• Ensure Design Control elements are satisfied for your programs:

• • Design History File support
  • Design Inputs
  • Design Outputs
  • Design Verification plans, protocols, and reports
  • Design Validation, including human factor/usability engineering
  • Design Reviews

• Guide risk management activities (Risk Management Plan, Risk Analysis, Risk Management Reports including post-production monitoring) in accordance with ISO 14971 and TIR 105
• Responsible for program strategies on simulated transport studies and contributing to the transportation validation strategy and respective plans
• Responsible for working with CMO/contractors to develop primary, secondary labels and leaflets (instructions for use)

• Directly engage and manage external vendors and contractors to formulate plans and advance technical aspects of the projects
• Engage in troubleshooting efforts to resolve development, transfer, or manufacturing problems

• Review and approve new and modified design / process specifications including product performance specifications, test methods, human factors, etc.
• Consistent application of technical principles, theories, concepts, and quality sciences / tools
• Accountable for quality conduct of projects, including design, data summary and interpretation and report generation for self

• Partner with other members of the Device organization and the Technical Operations Team to develop the product control strategy throughout product development and commercialization
• Support relevant aspects of supplier selections, contribute to device and packaging network strategy development
• Support day-to-day CMO/vendor-related activities including GMP production
• Work collaboratively with Regulatory Affairs colleagues to draft relevant elements of clinical and commercial regulatory submissions; support responses to health authority questions or interactions requiring device and packaging process knowledge

• Contribute to the authoring of regulatory submissions and request for information for clinical, commercial, and post-approval supplements (CTA, IND and MAA)
• Participate, communicate, and provide relevant information during Health Authority interactions, audits, and inspections
• Assist/conduct Failure Investigations and problem-solving sessions for non-conforming product

• Support change control activities as well as OOS, OOT, and Quality deviation investigations
• Lead components troubleshooting and strategy development for your responsible programs
• Achieve goals by working close collaboration with internal and external peers, partners, contractors, and consultants

• Ability to communicate ideas and knowledge effectively and clearly to other individuals, teams and customers
• Acts as a thought leader who collaboratively develops compliant solutions to challenging problems

• Provide guidance and work direction to external team members
  • As ACELYRIN builds out its portfolio, this position may require line management responsibilities

• Performs with the ability to work independently within defined parameters with minimal supervision, while learning from cross functional technical operations team and leadership

Qualifications and Skills Required:

• BS/BA Degree in Scientific Discipline (Biomedical/Mechanical engineering preferred); Advanced degree in pertinent areas preferred
• 8+ years in Device/Combination Products industry experience (Healthcare/ Pharmaceutical
• Thorough understanding of industry regulations: QSR/cGMP and ISO/ICH standards (21CFR820, ISO 13485, ISO 14971, ICH Q9, ISO 10993, ISO 11608, 21CFR Part 4)
• Highly experienced with design control principles and risk management (FMEA and Hazard Analyses)
• Experience in supplier, vendor, CMO management and relations, including contract and quality agreement management; contract negotiation experience is a plus

• Past experience as primary author of relevant sections of clinical and commercial regulatory submissions, e.g. IND’s, and BLA’s
• Experience interacting with global regulatory authorities in support of inspections and review activities (face-to-face, teleconference, written)
• Proven track record of accomplishments in biologics development and manufacturing
• Demonstrated trouble-shooting skills
• Ability to travel internationally to CMOs and vendors as needed for face-to-face engagement and troubleshooting

• Excellent problem solving and analytical skills

• Clear spoken and written communicator with concomitant interpersonal skills

• Ability to handle multiple projects simultaneously and independently

Essential behaviors and ways of working:

• Commitment to company values and culture
• Ethical, trustworthy, and reliable
• Team player and open to the ideas of the team

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