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Manager/Senior Manager, Quality Operations

Employer
Capstan Therapeutics
Location
San Diego, CA
Start date
Jul 27, 2022

View more

Discipline
Manufacturing & Production, Operations, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach
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Job Details

About Capstan Therapeutics

Capstan Therapeutics is developing a targeted delivery platform and therapeutics to reprogram immune cells in vivo in a scalable and controlled format, for a broad range of disease categories. The core technology originating from University of Pennsylvania comprises Targeted Lipid Nanoparticles (tLNPs) to enable off-the-shelf immunotherapies, with tight control of dosage and of activity of engineered cells. The objective is to advance transformative first-in-class and best-in-class products for oncology, fibrosis and inflammation-related diseases and blood monogenic disorders. Our dynamic start-up is founded by pioneers in the field of immunotherapy, regenerative medicine and drug delivery including experienced industry leaders and academic faculty members from U Penn.

In summary, Capstan Therapeutics aspires to become the leader of a new revolution in medicine, opening the avenue of in vivo reprogramming of the immune system and bringing this treatment modality to a broad range of medical needs. With locations in Philadelphia and San Diego, we are looking for talented individuals to join us.

The Opportunity

Capstan Therapeutics is seeking an enthusiastic Manager/Senior Manager to help build the Quality organization from a quality control and quality assurance perspective.

Responsibilities & Duties:

  • Provide day to day support for the governance, management, and coordination of activities related to the data integrity
  • Develop and utilize metrics and KPIs to assure program success and data integrity remediation progress
  • Support the various audit program across and within departments around data integrity concepts and training
  • Support the development of standardized tools and training
  • Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met.
  • Design and maintain a quality management system (QMS) across the GxP's Ensure the qualification, selection and management of vendors and contractors through a defined qualified process
  • Develop company SOPs, work instructions, and other processes and ensure appropriate training and adherence
  • Ensure that company and departmental SOPs, job descriptions, and training documentation are current, relevant, and appropriately maintained

Requirements/Qualifications:

  • Bachelor’s degree in Chemistry, Biology, Engineering, related field or equivalent required
  • Minimum three (3) years of related Quality experience in pharmaceutical cGMP environment
  • Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations 
  • Ability to build and maintain effective internal and external relationships, including with cross-functional teams, individual contractors, contract research organizations, and other vendors to effectively manage all quality related activities
  • Demonstrated and extensive hands-on experience in the preparation, review, and finalization of GxP policies, procedures, SOPs, trainings, and corrective actions for both early and late development programs
  • Excellent written and oral communication skills and the ability to effectively communicate with internal and external team members on project activities

If you are interested in hearing more, reach out to us. We believe that each team member will impact and improve the lives of those we work with, and those we work for—our patients.

Capstan is an equal opportunity employer. We value diversity and do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment.

Unsolicited resumes sent to Capstan from recruiters do not constitute any type of relationship between the recruiter and Capstan and do not obligate Capstan to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring managers or employees.

Company

Capstan Therapeutics is developing a targeted delivery platform and therapeutics to reprogram immune cells in vivo in a scalable and controlled format, for a broad range of disease categories. The core technology originating from University of Pennsylvania comprises Targeted Lipid Nanoparticles (tLNPs) to enable off-the-shelf immunotherapies, with tight control of dosage and of activity of engineered cells. The objective is to advance transformative first-in-class and best-in-class products for oncology, fibrosis and inflammation-related diseases and blood monogenic disorders. Our dynamic start-up is founded by pioneers in the field of immunotherapy, regenerative medicine and drug delivery including experienced industry leaders and academic faculty members from U Penn.

In summary, Capstan Therapeutics aspires to become the leader of a new revolution in medicine, opening the avenue of in vivo reprogramming of the immune system and bringing this treatment modality to a broad range of medical needs. With locations in Philadelphia and San Diego, we are looking for talented individuals to join us.

Find Us
Website
Location
9880 Campus Point Drive STE 220
San Diego
CA
92121
United States
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