Sr Manager, Biologics Drug Substance

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 or Agoura Hills, California. Remote work arrangement is possible but not preferred

Job Title:            Senior Manager, Biologics Drug Substance

Reports To:        Director, Biologics Drug Substance

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’s Biologics Drug Substance 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 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:

• Supports DS process lifecycle management, technology transfers, process development and implementation, as well as related timelines
  • Provides expertise and contributes to the Drug Substance sub-team and cross-functional Technical Operations Team
  • Technical support of DS process development, improvements, characterization, and validation in collaboration with internal and external peers, partners, contractors, and consultants
  • Management of CDMOs to formulate plans and advance DS aspects of projects
  • Responsible for troubleshooting and resolution of DS process development, tech. transfer and manufacturing problems
  • Participates in DS aspects of program and process risk assessments
  • Support of OOS, OOT, and Quality deviation investigations as well as change control activities
  • Collaborate with Regulatory Affairs colleagues to assist with drafting of DS elements of regulatory submissions; support responses to health authority questions or interactions requiring DS process knowledge
  • Contributes to DS process raw material troubleshooting and strategy development
  • Support of DS aspects of supplier selections
  • Support of day-to-day CMO-related activities necessary for process development and GMP production
  • Drafting of DS manufacturing history and development reports
  • Responsible for review of all DS-related GMP and non-GMP supporting documents related to DS development and manufacturing including protocols, master batch records, executed batch documentation, reports, change controls, etc.
  • Partnering with other members of the Technical Operations Team to develop the product control strategy throughout product development and commercialization

Qualifications and Skills Required:

• 4-6 years of relevant biologics DS experience in the biopharmaceutical industry
• Ph.D. in a related scientific discipline is desirable
• Experience with Mammalian and Bacterial Upstream processes is preferred
• Experience with Mammalian and Bacterial Downstream processes 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 early and late phase production to CMOs
• Ability to travel domestically and 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 with authoring of relevant sections of clinical and commercial regulatory submissions, e.g. INDs, and BLA’s
• 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.