Sr. Scientist

OVERVIEW We are currently searching for a skilled professional to join a well-known client’s team as a Senior Operations Scientist in Scarborough, Maine. The Senior Operations Scientist will serve as an individual contributor with deep expertise in reagent manufacturing processes, leading complex validation and experimental initiatives to support process optimization and product quality. Their work will have a direct impact on manufacturing efficiency, product performance, and innovation within the organization, making this an exciting career opportunity. RESPONSIBILITIES • Draft, execute, and report on validation activities for reagent manufacturing processes, including Operational Qualification (OQ), Test Method Validation (TMV), Performance Qualification (PQ), and Process Validation (PV) • Design and lead Design of Experiments (DOE) to evaluate reagent combinations, concentrations, and operating conditions • Coordinate experimental execution, analyze results, and present findings to cross-functional stakeholders • Develop and maintain data tracking tools for experimental results, critical process parameters (CPPs), and critical quality attributes (CQAs) • Utilize Quality Management Systems (QMS) to document study results in compliance with design control and validation procedures • Author and revise manufacturing documentation, including SOPs, specifications, safety instructions, and risk assessments • Apply Design for Manufacturability (DFM) principles to recommend process and product design improvements • Collaborate cross-functionally with R&D, Quality Assurance, and Operations teams to develop study plans and drive continuous improvement initiatives • Ensure all activities are conducted in compliance with applicable regulatory and internal quality standards EXPERIENCE Minimum of 6+ years of experience in a scientific or technical role within Operations, Manufacturing, or R&D required Hands-on experience with process validation, DOE, and data analysis required Experience with statistical analysis software such as Minitab or JMP required Experience in diagnostics or immunoassay technologies preferred Experience with data science or data visualization tools highly preferred Familiarity with project management tools (e.g., Smartsheet, Microsoft Project) preferred EDUCATION Minimum of a Bachelor’s Degree in Biology, Chemistry, Engineering, or a related scientific/technical discipline required Master’s Degree preferred To be a best-fit your strengths must include: • Strong expertise in reagent manufacturing and process validation methodologies • Advanced analytical and statistical analysis skills • Ability to design and execute complex experiments with a high degree of independence • Strong technical writing skills for protocols, reports, and SOPs • High attention to detail and commitment to data integrity and compliance • Ability to collaborate effectively across cross-functional teams • Strong problem-solving skills and ability to drive process improvements • Excellent communication and presentation skills • Ability to manage multiple complex projects in a fast-paced environment Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits. At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law. Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com. #msptalent