At ACELYRIN, 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.

 

Position Summary: 

Join our rapidly growing organization as the founding member of the ACELYRIN drug substance process development 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.

 

We are looking for a collaborative, positive, self-driven, individual with the ability to work seamlessly within a hybrid work environment.  The successful candidate will exhibit strong technical expertise, leadership and management skills, and a willingness to work both strategically and hands-on to achieve ACELERYIN 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:

 

·       Overall accountability for DS process lifecycle management, technology transfers, process development and implementation, as well as related timelines

·       Lead all activities related to Drug Substance and act as the DS lead on the cross-functional Technical Operations Team

·       Oversee and guide DS process development, improvements, characterization, and validation

·       Achieve DS goals by working close collaboration with internal and external peers, partners, contractors, and consultants

·       Directly engage and manage CDMO and process development contractors to formulate plans and advance DS aspects of the projects

·       As ACELYRIN builds out its portfolio, this position may require line management responsibilities

·       Engage in troubleshooting efforts to resolve DS tech. transfer and manufacturing problems

·       Help frame and contribute to DS aspects of program and process risk assessments

·       Support OOS, OOT, and Quality deviation investigations as well as change control activities

·       Work collaboratively with Regulatory Affairs colleagues to draft DS elements of clinical and commercial regulatory submissions; support responses to health authority questions or interactions requiring DS process knowledge

·       Lead DS process raw material troubleshooting and strategy development

·       Support DS aspects of supplier selections

·       Contribute as needed to DS manufacturing network strategy development

·       Support day-to-day CMO-related activities including GMP production

·       Leverage and help expand a fully externalized technology development and supply chain

·       Draft DS manufacturing history and development reports

·       Reviewing all DS-related GMP and non-GMP supporting documents related to DS development and manufacturing including protocols, master batch records, executed batch documentation, reports, etc.

·       Partner with other members of the Technical Operations Team to develop the product control strategy throughout product development and commercialization

 

Qualifications and Skills Required:

 

  • 10 years of relevant biologics DS experience in the biopharmaceutical industry
  • Ph.D. in a related scientific discipline is desirable
  • Microbial fermentation experience is desirable
  • Experience managing DS tech. transfer and cGMP production activities through CMOs
  • Familiarization with FDA and ICH guidance relevant to DS product lifecycle
  • Experience transferring biologics processes for Ph3 and commercial production
  • Ability to travel internationally to CMOs as needed for face-to-face engagement and troubleshooting
  • Proven track record of accomplishments in biologics DS process development and manufacturing
  • Proficiency in QbD and DoE
  • Past experience as primary author of relevant sections of clinical and commercial regulatory submissions, e.g.INDs, and BLA’s
  • Experience interacting with global regulatory authorities in support of inspections and review activities (face-to-face, teleconference, written)
  • Clear spoken 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 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, 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.

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