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Director, Quality Control Operations

Employer
Senti Biosciences
Location
Alameda, CA
Start date
Mar 21, 2023

View more

Discipline
Manufacturing & Production, Operations, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay
Thank you for your interest in a career at Senti Biosciences. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases in ways previously inconceivable. We are passionate about designing gene circuits to improve the “intelligence” of cell and gene therapies in order to enhance their therapeutic effectiveness against a broad range of diseases that conventional medicines are unable to address.
 
At Senti, we find purpose and meaning knowing that our efforts have the potential to improve the lives of patients and their families with more effective and safer treatment options. With science as our foundation and empathy as our key guiding principle, colleagues become friends, managers become mentors, and with time, cancer becomes history.

Summary:
Senti Bio is seeking a Director of Quality Control Operations, reporting to the Senior Director, Quality, to lead the Quality Control Operations team.  This key role will lead the implementation and maintenance of sample management, testing, and CoT/CoA generation in accordance with GMP requirements.  The QC Ops Director will establish and manage QC programs including Raw Material Management, Stability, data management/trending, and oversight of contract test labs for our novel cell therapy candidates.  Strong leadership skills, technical background and training are required. 
 
A successful applicant will be a seasoned  leader with experience bringing novel therapeutics to IND, a proven track record of establishing, leading, and continuous improvement of phase-appropriate QC programs, running QC operations within in-house and outsourced settings, extensive Data Integrity and compliance knowledge, and be comfortable in a fast moving and nimble culture supporting the clinical development and commercialization of investigational cell therapies.  
Responsibilities:
  • Responsible for strategic planning, capacity analysis, resource allocation, management and oversight of day to day operations of the Alameda-based QC Ops Laboratory for investigational novel cell therapy products
  • Assess and Drive the Development of the required right-sized QC framework processes and standards, laboratory data collection, and training of personnel to ensure GMP compliance
  • Oversee QC data analytics, monitoring, and trending for release and stability programs
  • Establish, oversee, and drive Raw Materials testing, Stability program, reference standard program, retain program, end-to-end sample management, OOS program, data management, trending
  • Oversees the receiving and method transfer from Analytical Development team, and drives the support of ongoing/lifecycle method qualification activities
  • Manages and leads Out Of Trend (OOT) and Out Of Specification (OOS) laboratory investigations, change controls, deviations, and CAPAs for relevant QC operations
  • Manages ongoing partnership with IT to continually strengthen data integrity across QC laboratories
  • Provides QC technical direction for external testing sites and inspections
  • Oversees outsourced vendor testing, manage data generated by contract test labs
  • Leads QC team in generating and managing data for Annual Product Quality Review (APQR) activities and regulatory filings.
  • Provides technical direction for specification and method development and troubleshooting
  • Leads the recruitment and management of a team of laboratory professionals including performance management, mentoring, and career development


Qualifications:
  • Bachelor's degree in life science or related discipline
  • At least 12 years or more of Quality Control experience in FDA regulated industry, preferably, biologic therapeutics including products in early-phase clinical development, with at least 5 years in a leadership/management role in Quality Control
  • Deep expertise in the area of data integrity regulatory expectations
  • Excellent verbal and written communication skills; ability to lead a Quality Control team as part of several multi-faceted projects
  • Strong interpersonal leadership skills; able to connect and work effectively with a variety of new and existing internal and external personnel and partners. Experience with change management in a fast paced environment
  • Experience with early clinical stage cell/gene therapy programs preferred


Salary and Benefits:
  • Compensation for this role includes base salary, annual target bonus and equity
  • The base salary range for this role is $200,000. Starting pay is determined by multiple job-related factors including a candidate’s skills, education and experience level, benchmark, and internal parity
  • Significant growth opportunity as the company expands
  • Empathetic, supportive and collaborative colleagues and work environments

Senti Bio is a publicly traded (Nasdaq: SNTI) gene circuit company headquartered in South San Francisco. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases using novel and unprecedented approaches.

We are committed to an inclusive and diverse Senti Bio. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse Senti Team. We welcome people of different backgrounds, experiences, abilities and perspectives and are an equal opportunity employer.

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