- ThermoFisher Scientific (Cambridge, MA)
- …Flow Cytometry) with a focus on Advanced Therapies like Cell and Gene Therapies; Working in complex global, matrix environments, including managing expectations of ... multiple stakeholders across multiple business units and regions; Building and maintaining relationships with customers and key opinion leaders in Biopharma segment; Developing and delivering technical presentations and trainings for a wide variety of… more
- ThermoFisher Scientific (Boston, MA)
- …B cell or other primary immune cell culture is desirable + Experience in Gene and Cell therapy is desirable + Knowledge of relevant ICH and regulatory guidelines ... and good understanding of GMP concept + Experience with analytical support for late-stage or commercial biological products and cGMP manufacturing + Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining… more
- Insight Global (Boston, MA)
- …and developing CAPAs to ensure efficient and effective processes across the cell and gene therapy organization. A strong candidate for this role will have a strong ... background in QC Analytical risk assessments, in GMP environment, leading, writing and reviewing deviations and investigations. Th This person will need to be comfortable managing several projects simultaneously with various stakeholders, maintaining a project… more
- Danaher Corporation (Marlborough, MA)
- …biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself ... and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand… more
- Fujifilm (Boston, MA)
- …lives. Join FUJIFILM Biotechnologies and help make the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across ... the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what we call Genki. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business… more
- Danaher Corporation (Boston, MA)
- …biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself ... and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System which makes everything possible. We are… more
- Dana-Farber Cancer Institute (Boston, MA)
- …stage. This requires: 1. Screening SRC agenda for clinical trials involving human gene therapy or infectious agent that proposals require IBC review, in the event ... that the study team did not correctly answer question 11.2, which routes the trial to biosafety. Reporting errors to OHRS and Study Team. 2. Assigns scientific reviewers of clinical trials, obtains additional information from sponsors as required by reviewers,… more
- Beth Israel Lahey Health (Boston, MA)
- …of regulatory documents to NIH/OBA, local bio safety committees on oncology human gene transfer trials. + Act as a liaison between the IRB and investigator ... to resolve regulatory queries and concerns. + Assist in the preparation and implementation of regulatory office SOPs. **Required Qualifications:** + Bachelor's degree required; Master's degree preferred in Regulatory Affairs. + 1-3 years related work… more
- Prime Therapeutics (Boston, MA)
- …BCOP + Experience in specialty drug management (trends, biosimilars, gene therapies, emerging treatment modalities), value-based care, medical and pharmacy ... drug benefits, and population health strategies + Experience working with health plans, pharmaceutical manufacturers, and provider networks to optimize specialty drug services + Experience in developing innovation solutions within the PBM/healthcare industry… more
- Beth Israel Lahey Health (Boston, MA)
- …mouse genetics, Mass Spectrometry, metabolomics, and RNAseq with validation by gene overexpression and knockdown to discover new mechanisms for the regulation ... of metabolism and immune responses. Has been awarded or has completed the requirements for a doctoral degree or foreign equivalent. Is a trainee pursuing advanced studies beyond the doctoral level in preparation for an independent career in a biomedical field.… more
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