At SGS Consulting, we go beyond resume-job matches, creating meaningful connections and pathways for individuals to thrive in defining careers.
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SGS_JOB_3719
Contract - 06 Months + (highest possibilities of contract extension)
This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submission/documentation for specific projects working as or working with the Regulatory CMC Lead and key stakeholders, primary contact for affiliates on Regulatory CMC activities in the assigned regions and managing of routine and non-routine Health Authority interactions as delegated. Depending on the stage of development and complexity of the program, this role can be a Regulatory CMC Lead for early stage development programs or working with the Regulatory CMC Lead for late stage development or commercial programs. The Regulatory CMC Lead is the primary global contact for Regulatory CMC activities, as delegated. This candidate must have proven leadership and abilities to work cross-functionally and across cultures. Strong communication, Regulatory CMC knowledge and interpersonal skills are required. 100% Remote or hybrid (Cambridge, MA or RTP)
Location (mandatory): Vacaville CA The Manufacturing Associate is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.
Location (mandatory): Vacaville CA We are seeking a highly motivated and experienced Quality Systems Support Specialist to join our team in Vacaville, CA. In this role, you will provide essential support to the Quality System Management process with document control and PQS integration, ensuring compliance with cGMP and global requirements.
Small Description: The Quality Control Biochemistry Associate II is responsible for contributing to key functional, tactical, strategic and operational aspects of the large molecule testing for Biochemistry group. This includes performing in-process, release testing, method transfer, validation testing and related activities associated with this testing.
Location : Cambridge, MA 02142 (Onsite) The Analytical Development team is seeking a highly creative and self-motivated candidate to join for a 6-month contract. This role will support the development of small molecule drug substances and drug products by developing innovative analytical technologies and establishing control strategies. The position will be responsible for chromatographic method development using supercritical fluid chromatography (SFC) and requires knowledge of organic chemistry, analytical chemistry, and experience working in a laboratory environment. Experience with analytical techniques such as UV, HPLC/UPLC, and LCMS is required.
Location: Research Triangle Park, NC 27709 (Onsite) Responsible for performing testing and sampling of bulk gases, monitoring utility parameters, inspecting raw materials, and collaborating with cross-functional teams including Microbiology and Manufacturing to ensure quality and compliance in research and production activities.
Location : Portsmouth NH 03801. The Dispensing Technician Level 1 supports the manufacturing of therapeutic proteins (API) by dispensing raw materials, including liquids, powders, acids, and bases, under cGMP conditions. This night-shift role requires attention to detail, adherence to cGMP and SOPs, and active participation in safety and quality processes within a controlled Class C environment.
Location (mandatory): Portsmouth NH The Quality Microbial Control Analyst V will be part of the Quality Microbial Control team, supporting the production of in-process and final product drug lots for customers. The role involves quality testing for customer stability studies, providing timely, high-quality results to meet Manufacturing demands. The Analyst will apply job skills, follow company policies, and contribute to projects and tasks of increasing scope. The role also provides technical support within the department and across the facility, potentially acting as a subject matter expert (SME) and supporting the supervisor in their absence.
At SGS Consulting, we go beyond resume-job matches, creating meaningful connections and pathways for individuals to thrive in defining careers.