Position Description

The Senior Manager, External Quality Control (QC) will report to the Senior Director of Quality and contribute to the successful achievement of Tr1X’s product development objectives through monitoring compliance with all applicable regulations (local, State, FDA, and other applicable agencies). The External QC Senior Manager will provide hands-on leadership for the Quality Control function. This role is currently an individual contributor, but responsibilities will include building, management, and mentoring the QC team as future headcount is needed. The selected candidate will be responsible for all aspects of Quality Control oversight, including external (CDMO) release and in-process assays, raw data review, method qualification and validation, stability, trending and GMP investigations for any analytical deviation, OOT or OOS. The ideal candidate must have experience with cell therapy analytical techniques, including flow cytometry, PCR (qPCR, QF-PCR, ddPCR, and/or dPCR), ELISA, safety-based assays (sterility, mycoplasma, endotoxin, etc.) and cell-based assays including potency and cytokine production. This role will also provide support for managing the Tr1X internal quality systems. The successful candidate will work with both internal and external stakeholders to meet timelines and internal deliverables.

Key Duties and Responsibilities

• Oversee – all aspects of external (CMDO) quality control operations including specifications, stability, data review, investigations, batch disposition, and analytical method qualification and validation.
• Assist – in the development of documentation and implementation of systems and SOPs.
• Review – internal and external records for compliance with applicable regulations and procedures, including batch records, SOPs and reports
• Follow – applicable regulations, including FDA, ISO, ICH, and company policies and procedures.
• Support – all Quality department needs as identified by management.
• Keep – abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.

The Team – Yes You Belong!

We are building a diverse, bold, agile, and collaborative organization where each team member works closely and communicates respectfully with each other. Tr1X leadership has high expectations for themselves and for you (and so should you!): we expect the company and all its employees to be deeply focused on bringing Tr1X’s therapies to patients at an accelerated pace.

Key attributes to this role include a “can do” attitude, enthusiasm for science, integrity, attention to details, problem solving, collaborative spirit.

You have:

• Bachelor’s or Master’s degree in scientific discipline
• A minimum of 7 (MS/MA) or 9 (BS/BA) years of related experience with a minimum of four (4) years of experience with QC management in the pharmaceutical, or biotech industry.
• Experience and knowledge in oversight of external CDMO quality control, and cell therapy analytical techniques, including flow cytometry, PCR (qPCR, ddPCR, and/or dPCR), ELISA, safety-based assays (sterility, mycoplasma, endotoxin, etc.) and cell-based assays including potency and cytokine production.
• Working knowledge of FDA and ICH regulatory guidance and regulations.
  Equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.
• Superior organization skills.
• Highly proficient in MS Office 365 (with an emphasis on MS Word).

Optimally you also have

• Experience with cell therapy products
• Experience with SOP authoring, document control, training and quality systems
• Working knowledge of Quality Operations and CTD/eCTD standards

You are

• Legally entitled to work for any employer in the US.

We offer

In addition to a competitive compensation package with stock options, Tr1X offers comprehensive benefits for our employees and their families. This includes:

• Medical, dental and vision insurance
• 401k with employer match
• PTO
• Long Term Disability (LTD)
• Company paid holidays, including the year-end holiday break