Quality Assurance Manager (GXP Operations)

About Cellarity:

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 of the cell’s trajectory from health to disease, and how cells relate to one another in tissues. Because the cell and its network of transcripts and proteins offer a more complete view of the complexity of human biology than any individual molecular target, Cellarity’s approach allows for more efficient drug discovery and is designed to drive higher rates of clinical success. Already, the company has seven drug discovery programs underway in diverse therapeutic areas that range from metabolic disease to immuno-oncology.

The successful Series B financing round validates the strength of Cellarity’s science and its potential to redefine drug discovery through its cell-centric approach.

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 of Quality Assurance, seeking a candidate with early-mid career experience in both QA/QC and genomics/DNA sequencing who is looking for a growth opportunity. Some experience in both areas is key to the role; one need not be expert in both on day 1 as we will mentor for this hybrid position. In this position, the individual will work largely on site, and 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 with 3-5 years working in an industry setting
• Experience with DNA sequencing, and/or standard genomics methods and technologies.
• 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.
• 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.