SGS_JOB_3105
Contract - 12 Months (possible extension)
M-F, 8am - 5pm. Full time, No OT... 100% Remote, Needed for at least one year, high possibility to extend for the full two years, No specific area/degree but must have a Bachelors Degree minimum... Candidate must be willing to participate/lead meetings and team calls occasionally. Manager values a candidate that is highly driven to learn to skills and take on new projects voluntarily. Manager likes candidates that are inquisitive. Need someone who is HIGHLY analytical. They'll be searching various systems, if they see something wrong they'll need to "go down the rabbit hole" to find out "why?" Need strong critical thinking skills to know when to search system to system for various bits of info. Must have experience working with multiple large data management systems, contracts and pricing, and/or contract development and analytics. Must have very strong writing/grammar and communication skills. Needs to have high attention to detail and accuracy. Interviews will be one with manager and then a panel interview. Must be able to perform high level Excel functions, formulas, vlook-ups. BONUS - manager would like to see Excel test scores. Resolve membership affiliation and inquiries from account management teams. Monitor Revenue Manager platform and boundary systems to confirm data accuracy. Responsibility for managing daily business tasks and processes with internal/external key stakeholders. Access and process data within reporting tools, including Revenue Manager, MicroStrategy, and boundary systems. Communicate and resolve membership discrepancies with internal and external customers; resolve inquires, maintain synchronization and integrity of membership. Create, maintain, and support a collaborative environment with external customers and internal business partners. Responsible and accountable for data compliance activities within membership and the oversight and execution of applicable processes and business decisions to achieve compliance. Ensure accurate and up-
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.
Location- Westborough, MA 01581. The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. Preferred: • Experience in a Biotech/Pharmaceutical company with a high growth, fast-paced environment. • Experience in qualification of analytical equipment, including those with computerized systems. • Experience in method validation/qualification/verification/transfer. Working Conditions: • This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs. • This is an on-site role working in a cGMP regulated manufacturing facility.
Location: Cambridge, MA 02139 Description: The primary role of the Media Prep Technician is to prepare pharmaceutical buffers, agar plates, and tissue culture media for Client’s lab operations in Cambridge, MA. Formulating buffers, plates and media for the PRD community allows our scientists to focus their time and skills on developing Breakthroughs That Change Patients’ Lives
A QA Specialist II (Quality Operations) ensures that manufacturing and related processes comply with regulatory and quality standards such as GMP and ISO. The role involves supporting production activities, reviewing documentation, overseeing compliance, and contributing to continuous improvement in a biopharmaceutical or life sciences environment.
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)
This position for employment is in the Andover Quality Control Microbiology Laboratory working first shift supporting Laboratory operations Monday through Friday with occasional weekend and holiday coverage. The candidate should be flexible to support both assays performed in the Laboratory, as well as office-based work as needed to support the business. Non-Standard Work Schedule, Travel Or Environment Requirements Some rotational weekend and Holiday coverage is required to support the commercial manufacturing schedule. Adhere to safe work practices and procedures, including aseptic gowning procedures
Location: - Westborough, MA 01581 (On-site) The primary purpose of the Analyst I position is to Support Quality Control Microbiological testing of drug substances, raw materials and process intermediates in support of clinical development and commercial programs under cGMP and GLP guidelines, address excursions and conduct investigations.