Sr MTO: Deviations & CAPA Investigator - GMP Cell Therapy
$50 - $56 per hourJMD Technologies Inc.
JMD Technologies Inc. is looking for a Sr. Staff MTO to join their team in Boston, Massachusetts. This role involves owning quality events and managing manufacturing investigations, ensuring compliance with GMP requirements and internal standards. The ideal candidate will have a Bachelor’s degree and over 6 years of experience in pharmaceutical manufacturing. Responsibilities include managing deviations, CAPAs, and leading investigations in real time on the manufacturing floor. Estimated hourly pay is in the range of $50–$56/hr based on skills and experience. #J-18808-Ljbffr JMD Technologies Inc.
$65 - $69 per hour
...member responsible for ownership of quality records at their Boston site. This role involves triaging manufacturer issues, leading investigations on quality events, and managing corrective and preventive actions. The ideal candidate will have over 6 years of experience in...SeniorTemporary work$122k - $150k
...to our mission of developing therapies that give people the power to... ...and approve Service Provider GMP documentation Review and approve... ...Quality Events, change controls, CAPA’s, and other GMP documentation... .../Executed Batch Records, Deviations, Change Controls, etc.) associated...SeniorLocal areaFlexible hours3 days per week$145k - $195k
...pursuing curative gene therapies to give patients... ...including R&D, GMP and treatment centers... ...collection centers and cell therapy labs) by... ...outsourced audits Manage Investigator Site Audit Plans... ...investigations, deviations, change controls, and CAPAs, especially those...SeniorFull timeWork at officeFlexible hours3 days per week$160k - $175k
...beyond one indication — a therapy that has already shown... ...be remote Position : Sr. Manager/Associate Director GMP Quality Reporting to :... ...: Provide oversight on investigations related to deviations and product quality... ...root cause analysis and CAPA implementation. Point of...SeniorContract workRemote workWorldwideFlexible hours$148.3k - $241.9k
...evaluation and selection Leads investigator meeting preparation and... ...monitoring visits and acts on deviations from plan Leads the development... ...or external audits and CAPA development as required Manages... ...in clinical trials within cell therapy is highly preferred Does this...SeniorContract work$127k - $190.4k
...Senior Manager, GMP Inspection Readiness The Senior Manager, GMP Inspection Readiness... ...modalities, including Small Molecule, Cell & Gene Therapies, Biologics, and Medical Devices.... ...response-related support (draft review, CAPA tracking, etc.). Maintain inspection...SeniorContract workWork experience placementSummer workRemote workFlexible hours2 days per week$150k - $215k
...company focused on developing precision therapies for solid tumors that aim to preserve... ..., including change controls, deviation investigations, CAPAs, OOS investigations, and method improvements... ...Support Author and review GMP documentation, including: Method transfer...SeniorContract workTemporary work$123.2k - $184.8k
...in Boston, MA, focusing on media development for stem cell culture used in cell and gene therapies. Candidates with a PhD and relevant experience in cell... ...internal stakeholders, while ensuring compliance with GMP standards. The role offers a salary range of $123,200-$...Senior- ...sciences company is seeking a Senior Field Application Specialist - Cell Therapy & Regulatory Markets to act as a strategic scientific partner.... ...Cell Biology or Immunology, with over 8 years' experience in GMP/GxP environments. You will deliver technical guidance, drive...Senior
- Sr Associate Scientist - Contract - Cambridge, MA Play a key role in advancing and optimizing autologous cell‑based therapy processes from bench to manufacturing. Proclinical is seeking a Senior Associate Scientist to join our client's Cellular Process Development team...SeniorContract work
$75 - $90 per hour
...Description Are you ready to revolutionize Cell & Gene Therapy? Join us in shaping the future of... ...cam‑follower design. Aseptic and GMP design. Design for compatibility... ...and Quality System policies. Support Deviation Management, CAPA, and Change Control activities, as required...SeniorContract workMonday to FridayShift work3 days per week$250k - $300k
Senior Director, Late Stage Cell Therapy Process Development Sana Biotechnology is growing, and we are hiring new team members who believe... ...expansion and differentiation, including raw material selection for GMP manufacturing. In depth knowledge and experience with...SeniorTemporary workImmediate start- ...Group is seeking a Senior Associate Scientist in Cambridge, MA, to play a crucial role in advancing and optimizing autologous cell-based therapy processes. The ideal candidate will have a Bachelor's degree in a science-related field and experience with aseptic cell...Senior
- ...biopharmaceutical company is looking for a Senior Scientist, Process Development to join their Watertown, MA team. This role involves executing cell culture experiments and downstream processing, along with data analysis and project contributions. The ideal candidate will have a...Senior
- ...clinical trial operations. Applicants should possess a Bachelor's degree and have at least 8 years of relevant experience, preferably in cell therapy. The position offers competitive salary and benefits in an inclusive culture. #J-18808-Ljbffr Regeneron Pharmaceuticals, IncSenior
$160k - $190k
...who believe in the potential of engineered cells as medicines, who want to challenge the... ...related fields with 3-5 years of direct cell therapy industry experience Significantly... ...reproducibility across platforms Passion for GMP transition, automation, and continuous process...SeniorTemporary workImmediate start- ...Senior Director of Manufacturing Technical Sciences Quality Assurance. This hybrid role involves overseeing quality for cell and genetic therapies, ensuring regulatory compliance, and leading a team across all stages of product life cycle management. The ideal candidate...SeniorFlexible hours
- AstraZeneca GmbH is seeking an Associate Director - Territory Operations Manager in Boston, MA to lead the cell therapy division. The role involves establishing service lines, overseeing clinical operations, and ensuring compliance with regulatory standards. The candidate...Senior
$35 - $37 per hour
Vertex Pharmaceuticals in Boston is seeking a Quality Control (QC) Specialist to perform testing for Cell Therapy. The role involves conducting various test methods, tracking QC data, and ensuring compliance with cGMP principles. Applicants should have a Bachelor's degree...Senior- ...Engineering Senior Scientist to join the Process Development - Technical Sciences group. This role involves leading activities for cell therapy products in Type 1 Diabetes programs, managing deliverables, and ensuring regulatory compliance. The successful candidate will...SeniorContract work
$123.2k - $184.8k
...Development, specifically in Media Development based in Boston, MA. This role requires expertise in media optimization for cell and gene therapy applications and collaboration with cross-functional teams. The ideal candidate will have a relevant PhD and significant experience...SeniorFlexible hours$160k - $200k
...Senior Field Application Specialist – Cell Therapy & Regulatory Markets BOSTON - NORTHEAST Cell Signaling Technology (CST... ...manufacturing. Leveraging deep expertise in CAR-T workflows and GMP/GxP requirements, the Sr. FAS provides the technical bridge between high-...SeniorTemporary workWork at officeLocal areaFlexible hoursShift work$71.25k - $161.7k
...company in Boston is seeking a Senior Associate in Quality Control. This position involves performing potency testing in compliance with GMP standards. The ideal candidate will have a Bachelor’s degree and at least 3 years of experience in the pharmaceutical industry....Senior$138k - $190k
...Description Job Description We are seeking a Senior Manager, GMP Quality Assurance to support and continuously improve... ...with global regulations (FDA, EMA, ICH) Manage investigations, deviations, CAPA, and change controls Support audits, inspections, and annual...Senior- ...advancing next‑generation radioligand therapies for cancer patients. In this role,... ...method development to support GMP readiness, technology transfer, and... ...data integrity. Support OOS/OOT investigations, root‑cause analysis, and CAPA implementation. Maintain compliance...SeniorWork at office
$147.2k - $220.8k
General Summary: The Principal Scientist, Stem Cell Research provides scientific leadership and ownership of stem cell differentiation... ..., and assay strategies supporting Vertex stem cell therapy programs. This is a hands‑on, lab‑based role with responsibility...Summer workCasual workFlexible hours$145.5k - $218.3k
...Manufacturing Science and Technology (MSAT) - Biologics & Cell Therapy is a key technical role within the Commercial... ...reports and process data summaries to support deviations, investigations, change controls, CAPAs, and continuous improvement initiatives. Support technology...Contract workRemote workFlexible hours2 days per week3 days per week- ...support for the manufacturing of cell and gene therapy (C>), small molecule, and... ...significant manufacturing investigations involving aseptic and/or... ...process monitoring program deviations and contamination events to... ...aseptic filling operations in a GMP environment. Establish...Contract workMonday to FridayShift work
$55 - $65 per hour
...GMP Operational Quality Senior Specialist Contractor The GMP... .... The GMP Operational Sr. Quality Specialist Contractor... ...closure Supports quality investigations/deviations and reviews corrective action... ...investigations ensuring appropriate CAPA actions are identified....SeniorContract workTemporary workFor contractors$65 - $69 per hour
...level staff member on the MTO is responsible for complete... ..., but not limited to Deviations, CAPAs, Change Controls, Risk Assessments... ...and Quality Control Investigations supporting cell manufacturing at our Boston... ...event investigations in a GMP‑compliant environment. Experience...SeniorContract workTemporary workImmediate startShift work
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