Scientist Aseptic Control

Title: Principal Scientist – Aseptic ControlLocation: Boston, MA (Hybrid – 3 Days Onsite)Employment Type: Contract (6+ Months)Status: Accepting CandidatesAbout the roleJoin a Manufacturing Science and Technology team supporting aseptic control strategies for sterile drug product manufacturing. This role focuses on contamination control, microbial strategy development, and cleanroom process oversight supporting biologics and cell and gene therapy manufacturing programs.The ideal candidate will serve as a technical expert in aseptic processing, partnering with cross-functional teams and external manufacturing partners to ensure sterility assurance and regulatory compliance.Key ResponsibilitiesProvide technical expertise in aseptic processing and microbial control strategiesSupport contamination investigations and environmental monitoring deviationsDevelop and implement risk-based contamination control strategiesSupport facility monitoring programs including environmental monitoring (EM), water, and gasesEvaluate and optimize disinfectant programs and microbial control proceduresSupport manufacturing investigations and root cause analysis activitiesCollaborate with cross-functional teams including Quality, Regulatory, and Process DevelopmentSupport regulatory submissions and inspection readiness activitiesProvide technical oversight of aseptic filling operations and cleanroom programsPartner with internal teams and external manufacturing partners (CMOs/CDMOs)Design and implement sterility assurance strategiesSupport microbial testing strategies and filtration validation programsDrive continuous improvement initiatives across aseptic manufacturing operationsEnsure compliance with global regulatory requirements and cGMP standardsQualifications10+ years of experience in aseptic drug product manufacturing or process development (Required)Strong aseptic control and microbiology experience (Required)Experience supporting biologics and/or cell and gene therapy (CGT) productsStrong knowledge of cleanroom operations and microbial control programsExperience with environmental monitoring (EM) and contamination controlExperience supporting manufacturing investigations and root cause analysisStrong knowledge of cGMP manufacturing requirementsExperience supporting sterility assurance programsExperience working with CMOs/CDMOsStrong technical communication and documentation skillsAbility to work in fast-paced manufacturing environmentsPreferred QualificationsAdvanced degree (PhD or equivalent) in Microbiology, Biology, or EngineeringExperience supporting cell and gene therapy (CGT) programsExperience supporting aseptic filling operationsExperience supporting regulatory submissions and inspectionsExperience working in commercial manufacturing environmentsExperience designing facility monitoring programsExperience supporting microbial characterization and testing programsCompensationEstimated hourly range: $75–$85/hr (W-2)Final rate within this range will be based on skills, experience, and interview results.Work Schedule: Hybrid – 3 days onsite weekly