- 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.
- 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).
- Experience with cell therapy products
- Experience with SOP authoring, document control, training and quality systems
- Working knowledge of Quality Operations and CTD/eCTD standards
- Legally entitled to work for any employer in the US.
- Medical, dental and vision insurance
- 401k with employer match
- PTO
- Long Term Disability (LTD)
- Company paid holidays, including the year-end holiday break
-
Principal Scientist, Biology
4 weeks ago
RayzeBio San Diego, United StatesJob Title: Principal Scientist, Biology · Location: San Diego · NH: R6 · Background · RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is ...
-
Infrastructure Manager
4 weeks ago
TribolaTech Inc San Diego, United StatesManage and optimize the delivery of IT services to meet agreed-upon SLAs and KPIs · Monitor the performance of IT services, identify areas for improvement, and implement necessary changes · Develop, negotiate, and maintain service-level agreements (SLAs) with internal and externa ...
-
Pre-Award Fund Manager
2 days ago
UC San Diego San Diego, United StatesThe Pre-Award Fund Manager is responsible for providing comprehensive financial analysis and pre-award grant support/submission to the CASPO Division at SIO. The Pre-Award funding manager will directly interface with faculty, post award fund managers, HR staff and C&G officers to ...
-
Marketing Associate
1 week ago
Whalen Furniture San Diego, United StatesThe Marketing Associate is a hybrid role responsible for designing, creating, and delivering marketing assets to support the growth and expansion of the company's products. The ideal candidate would have the ability to translate data and research that informs branding and product ...
-
Event Specialist
2 weeks ago
Ultimate Staffing San Diego, United StatesEvent Specialist needed for 6+ month temporary assignment. · Monday-Friday 7:30am-4:30pm · Onsite · Long term temporary · Pay $24.00-$26.00 per hour · In this role you will assist in the design and production of planned marketing programs which may also include other conference ...
-
Accountant II-Accounts Payable
2 weeks ago
Family Health Centers of San Diego San Diego, United States Full timeImpact Lives, Impact Community · Family Health Centers of San Diego (FHCSD) is passionate about providing exceptional health care to all, especially underserved communities with limited health care options. Founded by a Latina grandmother/community advocate over 50 years ago in B ...
-
Director Medical Writing
2 weeks ago
Partnology San Diego, United StatesAn exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for a Director of Medical/Technical Writing to join the Regulatory team and lead ...
-
Senior Acquisition Specialist
14 minutes ago
Vector Planning & Services, Inc San Diego, United States Full timeSeeking a qualified Senior Program/Acquisition Specialist to support the Logistics Integrated Information Systems Marine Corps (LI2S-MC) government sponsor. LI2S-MC supports new and deployed technologies across the Marine Corps. This position will work with both government and co ...
-
Senior Clinical Project Manager
1 week ago
EPM Scientific San Diego, United StatesSenior Clinical Project Manager · San Diego, CA (Hybrid) · $145,000 - $175,000 · Job Description · EPM is partnered with a publicly traded clinical stage Biotech in sunny San Diego. Using a traditionally underused receptor attached to the Central Nervous System, they are unlockin ...
-
VP, Investment Advisory Platform
1 day ago
Realta Wealth San Diego, United StatesPosition Title: VP, Investment Advisory Platform, Realta Wealth · Overview: Realta Wealth is currently seeking a VP, Investment Advisory Platform. This is a unique opportunity to join one of the fastest growing Independent Broker Dealers and participate in designing, developing a ...
-
Director of Regulatory Strategy
3 days ago
Cypress HCM San Diego, United StatesThe role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product develo ...
-
Project Associate
1 week ago
Biocom California San Diego, United StatesPosition Summary: · The position of the Project Associate will provide high-level administrative support to the Vice President and Managing Director, Purchasing Group. Secondary responsibilities include supporting the Executive Director of Sales. · Key Duties & Responsibilities: ...
-
Chief Financial Officer
3 weeks ago
Adjoin San Diego, United StatesDo you find fun in working with numbers? Are you looking to launch your next career step as a CFO and want to work for a cause driven, people focused organization? Adjoin is seeking an individual who has strong leadership, strategic, and communications skills as related to financ ...
-
Sr. Accountant
3 weeks ago
Tentamus Fredericksburg, VA San Diego, United StatesTentamus North America is seeking a Sr. Accountant to join our team to manage the full cycle accounting and financial reporting process. · Main Responsibilities · Manage cashflow: forecasting need, planning for foreign currency needs in advance, and alerting upper management fo ...
-
Project Manager
4 weeks ago
Exponents Insta USA Inc San Diego, United StatesThis profile requires to coordinate various projects such as tradeshows, events, conferences and other customer related events. The project manager will oversee the project and coordinate with other cross functional teams and implement schedules and timelines. · Tasks / activitie ...
-
The Higgins Group, Inc. San Diego, United StatesVividion Therapeutics seeks a decisive yet collaborative leader with deep translational and early clinical development experience in immunology to drive forward its pipeline of novel small-molecule precision medicines and build a first-class team. The S/VP, Immunology will be a h ...
-
Project Engineer
11 minutes ago
Teichert San Diego, United StatesPurpose · The purpose of this role is to develop well-rounded future talent with construction expertise across multi-disciplines – ultimately creating professionals with experience in the full scope of construction management. Specifically, this role assists and supports Field O ...
-
Marketing Director
3 weeks ago
Whalen Furniture San Diego, United StatesMarketing Director will lead and oversee all of the company's marketing efforts from creative to operations. This role may include developing year-long strategic plans, creating and executing campaigns, managing budgets, and leading projects and staff. Responsible for designing, ...
-
Digital Support Technical Specialist
11 hours ago
California Coast Credit Union San Diego, United StatesUnder general direction of the AVP, Credit Union Technology Services, serves as the first level of contact for managing digital platform support for service interruptions and communications, as well as daily vendor relations with Digital Commerce service providers. Provides digit ...
-
Sales Account Manager
3 days ago
SOITEC San Diego, United StatesJob Responsibilities: · Regional sales operation: · Manage forecasts, quotations, PO's, backlogs, account receivables, logistics, external/internal reports for continuously smooth operation. · Prepare external/internal meetings and presentations, contract negotiations and agreeme ...
Sr. Manager, External QC - San Diego, United States - Tr1X
Description
Job Description
Job DescriptionTr1X ("Trix") is a biotechnology company focused on engineering cures for autoimmune and inflammatory diseases. The company develops cellular therapies with the potential to cure disease by inducing immune tolerance and restoring homeostasis.
Tr1X has a state-of-the-art technology platform that allows for the scalable generation of engineered living drugs to help patients suffering from debilitating diseases with high unmet medical need. More information can be found at
Position DescriptionThe 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
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:
Optimally you also have
You are
We offer
In addition to a competitive compensation package with stock options, Tr1X offers comprehensive benefits for our employees and their families. This includes:
At Tr1X we believe that a diverse, open, and inclusive environment and culture is key to our success. Tr1X will not be influenced in recruitment, hiring, promotion or any other employment practices by race, color, citizenship status, national origin, ancestry, sex, sexual orientation, gender identity/expression, age, religion, physical or mental disability, medical or genetic condition, marital status, veteran status, or any other characteristics protected under applicable federal, state and local laws. Tr1X will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable laws.
Note to External Recruiters: Submission of unsolicited resumes prior to an agreement set in place will not create any implied obligation.