Quality Assurance Manager/Sr. Manager (GXP Operations)

Company Summary:

Founded in 2017 within Flagship Labs, Cellarity’s new approach to drug discovery is based on the computational modeling of cell behavior, leading to a more complete understanding of system and network biology to uncover cell-behavior-targeted medicines for a wide variety of diseases. Cellarity recently raised $123 million in Series B financing. The round included contributions from funds and accounts managed by BlackRock, The Baupost Group, Banque Pictet on behalf of their clients and eight other investors alongside Flagship Pioneering.

Cellarity is generating unprecedented biological insights by combining its unique expertise in network biology, high-resolution data, and machine learning. The result is a new understanding both of the cell’s trajectory from health to disease, and of how cells relate to one another in tissues. Because the cell and its network of transcripts and proteins offer a far more complete view of the complexity of human biology than simple read out of any individual molecular target, Cellarity’s approach allows for more efficient drug discovery and thus is designed to drive higher rates of clinical success. The company already has seven drug discovery programs underway in diverse therapeutic areas that range from metabolic disease to immuno-oncology.

Position Summary:

The Technology group at Cellarity Inc. is developing and operating DNA sequencing, single cell analysis and other cutting-edge data generation methodologies. We are recruiting for the position of Manager or Senior Manager (based on candidate experience level) of Quality Assurance. In this position, the individual will have a hands-on role in QA/QC activities including:  data analysis/review, samples tracking, cGXP documentation, SOPs and cGXP training as part of implementation and operation of cGCP to support testing of clinical samples on site. This position will report to the Director of cGXP.  

Key Responsibilities:

• Oversee QA requirements for cGCP processes. Be the final sign off and review of studies from a quality standpoint.  Have responsibility for leading resolution on deviations and CAPAs related to the clinical testing.
• Ensure that a QA system is in place and is compliant to allow clinical sample testing in this laboratory, suitable to support FDA filings.
• Ensure complete validation of instrumentation and assays prior to clinical sample testing.
• Ensure that a compliant samples receipt system and sample storage system is in place.
• Manage documentation for GXP processes.
• Train laboratory personnel in GLP and GCP.
• Perform laboratory and study audits on a regularly scheduled interval suitable for FDA filings.
• Perform other audits to including facility and vendor audits.
• Create, maintain and oversee an archival system for documentation.
• Operate with hands-on involvement in day-to-day activities.

Qualifications:

• Postgraduate degree or equivalent professional experience and research experience; At least 3-5 years post-degree experience preferred for manager level and 5-7 years for Sr. Manager.
• Experience in QA systems for clinical testing of samples.
• Experience with laboratory sample handling and QC.
• Demonstrated experience and proficiency with documentation/archiving, tracking and reporting in a GXP or equivalent context; Experience with materials management a plus.
• Direct experience in laboratory research or clinical testing; must have a good grasp of modern biological concepts, molecular biology and genomics.
• Experience with DNA sequencing, sequence data/analysis or other cutting-edge data biological data types preferred.
• Ability to work independently and with limited infrastructure.

Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.   Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.