Lead Analytical Scientist, Biologics & Vaccines (Regulatory)
Moderna
Scorpion Therapeutics is seeking an Analytical Program Lead (APL) to oversee analytical activities for biologics or vaccines, supporting regulatory filings (IND, BLA/MAA) and lifecycle management. The role requires a PhD with 5+ years in the field or an MS/BS with 8+ years of industry experience, focusing on biologics or vaccine analysis, method validation, and tech transfer. 100% onsite in Norwood, MA with collaboration across QC, Regulatory CMC, MS&T, and Manufacturing to ensure regulatory #J-18808-Ljbffr Moderna
$36 - $41 per hour
...Eurofins seeks a molecular biology scientist to support analytical development of oligonucleotide and mRNA-LNP products in Boston. The role involves... ...methods, and collaborating across teams while maintaining regulatory compliance and scientific documentation standards....RegulatoryHourly pay$36 - $41 per hour
...providing a unique range of analytical testing services to clients... ...design and execute molecular biology and cell-based assays, analyze... ..., detail-oriented scientist who can work with increasing... ..., method documentation, and regulatory submission content, as appropriate...RegulatoryHourly payFull timeMonday to Friday$109.2k - $174.6k
...You’ll Do Serve as the Analytical Sciences technical transfer lead for assigned analytical... ...with method-development scientists before formal handoff... ...QC, Quality, ATO, and Regulatory to align method qualification... ...platforms relevant to biologics, vaccines, nucleic acids, or...RegulatoryPermanent employmentLocal areaWork from home- ...Job Description Job Description Scientist/Senior Scientist, Biology Lead – Kidney Experience About the Role We are seeking a highly motivated... ...closely with chemistry, delivery, translational, regulatory, and external teams · Help define scientific strategy...Regulatory
- Moderna seeks a Principal Scientist to lead quantitative science across the CMC lifecycle in Norwood... ...advanced statistical solutions, guide regulatory submissions, and deploy data-driven... ...with Process Development, Analytical Development, Quality, Manufacturing, and...Regulatory
$109.2k - $174.6k
...and execution support for analytical method lifecycle management... ...Control, Quality Assurance, Regulatory Affairs, Manufacturing Sciences... .... Here's What You’ll Do Lead and support chemistry-... ...pharmaceutical, biotechnology, biologics, or vaccine environment. Experience authoring...RegulatoryPermanent employmentFull timeContract workWork from home- Moderna in Norwood, MA seeks an analytical CMC professional to provide executional support for method validation, transfer, and lifecycle... ...-functional teams, prepare documentation, and help ensure regulatory readiness while operating in a GMP-regulated biopharma environment...Regulatory
$138.4k - $207.6k
...Vertex Pharmaceuticals seeks a Principal Scientist in Microbiology to lead analytical science and technology efforts for biologics, cell therapy, and gene therapy programs.... ...microbiology method lifecycle management, regulatory compliance, external laboratory oversight,...RegulatoryContract work- Senior Scientist, Analytical Development (Project Management) Job Description... ...,CRISPR Therapeuticsis a leading biopharmaceutical company focused... ...also author sections of regulatory briefing packages or... ...Minimum Qualifications Ph.D. in Biology, Chemistry, Chemical Engineering...RegulatoryContract work
$109.2k - $174.6k
## Scientist, Process Development (Formulation... ...development and analytical development to... ...enzyme formulation, biologics stability,... ...oligonucleotide, vaccine, or other nucleic... ...troubleshooting, regulatory-supporting documentation... ...to build the leading mRNA technology platform...RegulatoryPermanent employmentWork at officeWork from home$138.4k - $207.6k
...Principal Scientist position leading analytical separation methods expertise for late-stage and commercial biologic programs at a pharmaceutical company. Responsibilities include method... ..., validation protocols, reports, and regulatory submissions for biologics programs...Regulatory- FM in Norwood, MA seeks a Lead Research Scientist in Analytical Chemistry to shape research on material behavior, contamination, degradation mechanisms, chemical hazards, and practical loss prevention. You will develop innovative analytical methods and lead research, engineering...Relocation
- Moderna is seeking a scientific lead in Analytical Development to transfer and implement analytical methods into Analytical Testing Operations... ...ensure methods are reproducible and compliant with GMP and regulatory expectations. This role requires substantial hands-on method...Regulatory
$104.2k - $156.2k
...is seeking a talented Research Scientist to join a collaborative research team focused on Biologics discovery and optimization in... ...strongly experienced in LC-MS based analytical method development and... ...also include inclusive market-leading benefits to meet our employees...Full timeSummer workFlexible hours- ...in Watertown, MA, seeks an experienced scientist to lead bioanalytical LC-MS/MS method... ...assays for protein/peptide biomarkers in biological matrices, overseeing method transfer to... ...mentoring junior scientists while ensuring regulatory compliance and high data quality. #J-...Regulatory
- ...Job Description Seeking a Lead Medical Technologist (blood bank) / Clinical Laboratory... ...bench testing, ensuring quality and regulatory compliance, accurate performance of all... ...deviations to FDA through Centers for Biologics Evaluation and Research (CBER). May be required...RegulatoryFull timeBank staff
- ...Biotech in Massachusetts seeks a leader to build and guide the Cellular Biology function, driving strategy, experimental capabilities, and high standards for cellular and mechanistic biology. You will lead hand-on development of bone marrow-focused translational models and...
$39 - $48.02 per hour
...Available About the Opportunity A leading healthcare organization is seeking an experienced... ...with established procedures and regulatory requirements. Evaluate specimen... ...Laboratory Science, Medical Technology, Biology, Chemistry, or a related life science field...RegulatoryHourly payPermanent employmentTemporary workBank staffLocal areaRelocation packageMonday to FridayShift work- Integra LifeSciences is seeking a Supervisor, QC Analytical Laboratory to lead the analytical laboratory operations and ensure compliant testing... ...The role focuses on data integrity, method validation, and regulatory readiness. You will oversee lab activities, manage...Regulatory
$93.8k - $174.2k
Reporting Senior Scientist I, CMC Analytical Development Reporting Senior Scientist I, CMC Analytical Development Description We are seeking an... ...to ensuring the quality, safety, efficacy, and regulatory compliance of radiopharmaceutical products. This role will...Regulatory- ...seeking an accomplished, creative, and highly collaborative scientist to lead the Cellular Biology function. The ideal candidate will bring deep... ...candidate selection, and assay development. Contribute to regulatory filings, data interpretation, and scientific publications...Regulatory
$100k - $120k
...is seeking an experienced and hands-on Analytical Chemist to join the R&D Research team. Responsibilities... ..., actionable technical reports. • Lead QA/QC activities related to production... ...environment, and knowledge of relevant regulatory guidelines (FDA, ICH, ISO, REACH, etc.)....RegulatoryFull timeContract work$142.5k - $256.5k
...is seeking an Individual to lead host strain, vector, and expression... ..., plasmids, and related biological materials supporting Moderna’... ...Partner with process development, analytical development, downstream... ...supporting documentation, and regulatory responses as needed.Serve as...RegulatoryPermanent employmentFull timeWork at officeWork from home$128k - $146k
...Position Summary The Scientist II, Analytical Development will be a key member of the Analytical... ...neuromuscular disease. The candidate will lead method development, impurity... ...to summarize analytical activities for regulatory filing. Perform/guide routine maintenance...RegulatoryFull time$120k - $130k
...Field Application Scientist Boston, MA... ...everywhere deliver novel vaccines, therapeutics,... ...production and biologics safety testing to... ...many of the world's leading biopharma,... ...custom manufacturing, analytical testing, and... ...development, CMC, GMP, and regulatory requirements...RegulatoryFor contractorsLocal areaWork from home- Integra LifeSciences in Massachusetts seeks a Supervisor, QC Analytical Laboratory to provide technical and operational leadership for... ...finished products and stability samples, with data integrity and regulatory readiness. You will supervise daily lab operations, oversee...RegulatoryContract work
- Integra LifeSciences Corporation seeks a Supervisor to lead the Quality Control Analytical Laboratory, directing analytical testing across raw materials... ..., and finished products to ensure timely release and regulatory compliance. You will drive method validation,...Regulatory
- ...Therapeutics, Inc. is seeking an Associate Director, Pharmacovigilance Scientist to advance safety evaluation across clinical development and... ...teams. The role requires extensive PV experience, strong regulatory knowledge, and ability to produce safety documents. This...RegulatoryRemote job
- ...Area, MA seeks a QC Associate - Bioassays & Molecular Biology (cGMP) on a 6+ month contract. You will support cGMP... ...of materials and finished products, execute critical analytical methods, and help ensure regulatory compliance. The role involves mammalian cell-based potency...RegulatoryContract work
- ..., a Lilly subsidiary in Watertown, MA, seeks an experienced scientist to lead LC-MS/MS bioanalytical method development and validation supporting... ...with CROs and discovery teams to ensure data quality and regulatory compliance. A PhD with 3+ years in industry is required. #J...Regulatory
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