Apex Systems Inc
Apex Life Sciences is seeking a highly motivated, results-oriented, self-starter to join a new and dynamic team responsible for successful development and characterization of clinical-scale manufacturing processes. The successful candidate will contribute to the development, implementation and characterization of state-of-the-art processing technologies to deliver scalable and robust manufacturing processes, and support successful tech transfer for GMP manufacturing and release at a CMO. \r\rResponsibilities:\r\r\rActively contribute to development, implementation, characterization and successful execution of robust, state-of-the-art CART manufacturing processes.\rSupport clinical-scale non-GMP/ GMP IND-enabling manufacturing operations, including Tech Transfer to CMO and support of successful GMP manufacturing of clinical material.\rContribute to relevant and impactful innovation programs to enhance CART manufacturing technologies/ capabilities and work-processes (such as alternate transfection and cell engineering strategies, media development, disposable/ closed production systems and automation), aligned with emerging business drivers and Regulatory expectations.\rContribute to Project Technical Teams and communicate and collaborate effectively to ensure effective interactions with all stakeholder groups \rDemonstrate strong “personal leadership”/ accountability and technical and interpersonal skills, and apply scientific and technical experience to ensure safe, high-quality lab practices\rEnsure high-quality, timely documentation in electronic laboratory notebooks and Technical Reports and contribute to Regulatory Filings and responses to Regulatory questions as appropriate.\rPresent data/ strategy to scientists (and management) in internal venues (technical meetings, Project Team meetings) as appropriate.\r\r\rRequirements:\r\r\rBS or MS degree in Molecular Immunology/ Molecular Biology, Bioengineering, or related degree (with appropriate cell and gene therapy focus)\r3 years (1 for MS) of experience in biotech/biopharma industry (preferably in the development and characterization of manufacturing processes for cell- or gene-based therapies).\rProcess development for GMP manufacturing of cell- or gene-therapies\rCulture and characterization of primary T-cells, T-cell molecular biology/ engineering\rAseptic cell culture technique\rDirect experience with T-cell activation, viral transduction, and mRNA electroporation is highly desirable\rFamiliarity with cGMP and relevant Regulatory Guidance documents a plus\rFamiliarity with single-use bioprocessing such as WAVE bioreactors and CliniMACS Prodigy a plus\rExperience with process scale-up and scale-down is desired\rKnowledge with Design of Experiments a plus\r\r\r***For immediate consideration, please email your updated resume to email@example.com with 'Scientist - manufacturing processes' in the subject line.\r\r\r\r\r\r\r\r\rEEO EmployerApex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at firstname.lastname@example.org or 844-463-6178.
Apex Systems Inc
Website : https://www.apexlifesciences.com/
Apex Life Sciences is a division of the 3rd largest clinical/scientific staffing and services firm in the U.S. We match top scientific, engineering, and clinical research professionals at all career levels for contract, contract-to-hire, and direct hire opportunities.