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

Position Role and Responsibilities:

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 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!

Position Role and Responsibilities:

This position is responsible for maximizing the value of Angiocrine’s therapeutic assets and programs through best- in-class clinical project and program management. This experienced program management leader will have a demonstrated track record of leading program management for global drug development programs across the product lifecycle.

  • Lead and run the Clinical Development Team(s) by providing multidisciplinary program and project management support to drive execution and development of therapeutic assets.
  • Provide program management and matrixed leadership to project teams, and partner with leadership and key influencers to align product strategy with disease area program strategy and corporate strategy.
  • Develop and continuously improve Angiocrine’s product development and commercial processes.
  • Provide operational insight into feasibility, timeline and cost estimates during clinical study development
  • Manage clinical study timelines for the various clinical projects
  • Oversight of clinical study budgets and manage the budget through the lifecycle of the project
  • Ensure timely delivery of operational deliverables
  • Drive decision making and integrate all operational considerations for studies to ensure goals are attainable prior to implementation
  • Review key metrics and key performance indicators across various studies to track study progress
  • Provide proactive creation and implementation of risk mitigation strategies
  • Provides innovative and flexible operational solutions and options to the teams; assists in preparing scenarios for creative solutions to operational challenges
  • Responsible for clinical trial resource forecasting and resource allocation for clinical studies across one or more clinical projects

Position Requirements:

  • BA or BS degree and minimum 7 years of relevant (including program/project management) experience.
  • Direct people leadership experience with demonstrated success of leading high-performing teams to functional objectives Knowledge of clinical trials and drug development process with demonstrated record in R&D program management in biotechnology.Prior experience in cellular therapy preferred.
  • Broad understanding of the multidisciplinary functions contributing to effective and efficient drug development.
  • Appreciation of CMC, pharmacology, toxicology, PK and clinical requirements to support major regulatory filings and the interdependencies between various subject areas (e.g., CMC, Pharm/Tox, PK, Clinical, Regulatory, Marketing, Finance) from a planning and risk management perspective.
  • Independent and self-directed working style
  • Excellent communication and organization skills
  • Detail oriented team player with effective planning, organization and execution 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.

  • Proficiency with Project Management software

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!