Our values are the critical foundation upon which we have built Angiocrine Bioscience.

Esprit de Corps • Commitment • Excellence • Laser Focus

Our team challenges conventional wisdom and pushes the boundaries of scientific discovery and innovation. Our values are reflected in how we think about the patients we aspire to help, the science we do, how we operate as a company, and who we hire.

We look for energetic, creative, self-motivated people who enjoy the breadth and depth of activities one finds in a small, entrepreneurial company. In joining Angiocrine Bioscience, employees are part of a vibrant multi-disciplinary team, committed to developing innovative engineered cellular therapies for treating numerous medical conditions.

Angiocrine Bioscience is committed to the principles of equal employment opportunity. Applicants are considered for all positions without regard to race, sex, sexual orientation, color, religion, national origin, age and disability or any other status protected by applicable law.

Current Openings
Manufacturing Supervisor – Cell Therapy

The Manufacturing Supervisor – Cell Therapy, is part of the Angiocrine manufacturing team that supports clinical production of cell therapies at a Contract Manufacturer. The Supervisor is responsible for managing all cell related tasks to produce clinical products. The Supervisor will ensure execution of production plans at the CMC while managing internal manufacturing cell therapy staff performance to meet operational goals.

Position Role & Responsibilities:

  • Manage personnel to execute cell isolation and cell expansion functions at a CMC.
  • Provide leadership, guidance, training and direction to staff in alignment with cGMP requirements.
  • Collaborates with area managers to ensure accuracy and adherence to production schedules.
  • Set daily work activities and roles for staff in collaboration with CMC to meet production demands.
  • Coordinate internal product testing and sample submission to contract laboratories.
  • Assist area manager with Environmental Monitoring monthly projections and changes.
  • Proactively identifies and assesses operational risks, communicates issues to senior management and cross-functional support teams.
  • Assists area manager in the design of a Cell Therapy Cell Expansion training plan and execution.
  • Perform additional job-related duties as required.

Position Requirements:

  • Extensive experience in adherent cell thawing, expansion, feeding, and harvesting; including cell counting, cryopreservation, sample processing, and intermediate formulations.
  • Proficiency in ISO-7 clean room manufacturing and comprehensive knowledge of Good Manufacturing Practices (GMP).
  • Experience with generating large tubing assemblies, autoclaving, identifying and use of tubing connectors (MPC, Luers, etc.).
  • Experience with 50 L to 100 L bioreactor systems including media supplementation, large bore tubing welding, and making aseptic connections from various vessels to a bioreactor.
  • Ability to lead manufacturing teams to adhere to demanding production schedules.
  • Authoring, revising, and reviewing of Batch Records, SOPs, and on the job-training documents.
  • Experienced in troubleshooting, investigation, and root cause analysis in a cGMP environment.
  • Must be able to lift 50 lbs.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must work with living human cells and various chemicals.
  • Due to the nature of production work, overtime and weekend work is a requirement of employment and is variable based on company needs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Preferred Education and Experience

  • Related Bachelor’s degree (Biology or Biotechnology)
  • 7 + Bio-industry experience with a minimum 5 years cGMP cell culture and/or bioreactors
  • Minimum of 2 years’ experience in a leadership role in a cGMP setting.
  • Professional experience working for a contract manufacturing organization is preferred.

Additional Desired Skills and Knowledge:

  • Strong computer skills with Word and Excel and other electronic manufacturing systems.
  • Detail oriented team player with effective planning, organization and execution skills.
  • Good organization and time management skills.
  • Ability to work in a high paced team environment.
  • Strong written and verbal skills.

Additional Information:

This position is based in San Diego, CA.
Angiocrine is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now
Director of Quality, Cell Therapy

This position is responsible for leading the quality operations and support compliance activities of clinical development and commercialization of Angiocrine’s engineered cell therapy products.

  • Primary role is to serve as quality leader of Angiocrine’s cellular therapeutic programs.
  • Develop and maintain essential quality systems for both clinical development and commercial environments, including document control (including SOPs), change control, CAPA, training, validation, and auditing.
  • Provide QA oversight and day-to-day management of in-house QC lab.
  • Provide QA oversight of CMOs. Negotiate quality agreements, and conduct CMO qualification.
  • Manage implementation of required changes with CMO to meet cGMP requirements and internal standards.
  • Work closely with the company’s CMC team, assuring accurate and timely flow of information including, but not limited to: specifications, batch records, and product release for cellular drug products, all in compliance with company standards and cGMP procedures.
  • Review and approval of development, transfer, master and study specific validation protocols and reports.
  • Verification of process data and approval of technical protocols, reports, and chemistry, manufacturing and control sections of regulatory submissions.
  • Approval of production related activities via approval of: specifications, master batch records, change controls, sampling and testing plans, stability study protocols and reports in compliance with cGMP regulations.
  • Lead deviation and out of specification investigations.
  • Lead internal quality audits to assess Angiocrine’s compliance to regulations. Facilitate and assist with the preparation, coordination, and management of regulatory inspections of Angiocrine and contract manufacturers.

Position Requirements:

  • BS in biology or related field with an advanced degree desirable
  • Minimum of 10 years’ progressive quality assurance experience in clinical or commercial pharmaceutical/biotech operations and development; experience in both development and commercial operations required
  • Advanced knowledge of quality assurance principles, concepts, industry practices and standards
  • Strong proven hands-on experiences with GLP, GMP, GCP compliance matters and contractor management in the bio/pharma industry
  • Experience working with contract manufacturers
  • Experience with the regulatory submission and approval process
  • Previous experience with building quality systems and company-wide SOP systems for all phases of clinical development and commercialization
  • Independent and self-directed working style
  • Excellent communication and organization skills
  • Ability to work in a high paced team environment.
  • Must embrace positive, pro-active and “no-excuses” style of execution—must emanate ‘can-do’ attitude.

Additional Desired Skills and Knowledge.

  • Direct experience with FDA regulations in cell therapy manufacturing
  • Strong computer skills with Word and Excel and other electronic manufacturing systems.
  • Proficiency with eCTD software, document management systems, review management/version control software, Microsoft Office and Adobe Acrobat
  • Detail oriented team player with effective planning, organization and execution skills.
  • Good organization and time management skills.

Additional Information:

This position is based in San Diego, CA.
Angiocrine is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now