Remote CMC Project Manager - Late-Stage Biologics
Eliassen Group
- Remote job
A leading biotechnology consultancy is seeking an experienced CMC Project Manager to lead drug product and device workstreams for BLA readiness. The role involves maintaining project momentum, coordinating with cross-functional teams, and providing executive updates aligned with regulatory timelines. Candidates should have at least 6 years of experience in CMC project management within the biotechnology or pharmaceutical sector, and proficiency in Smartsheet is essential. The position is remote with an initial contract through September 2027. #J-18808-Ljbffr Eliassen Group
- ...is seeking an experienced CMC Project Manager to provide execution leadership... ...BLA readiness and late‑stage commercialization activities... ...experience supporting late‑stage biologics programs Strong background... ...preferred TRAVEL & LOCATION REMOTE. START & TERM Immediate...Remote workContract workImmediate start
- ...discovery, Product Development/ CMC represents the next barrier/... .... The complexity of biological systems, the rigor of regulatory... ...cutting edge programs across early stage, late stage and commercial product... ...principles, model lifecycle management, or deployment of analytical...SuggestedFull timeLocal area
$150k - $170k
...is a clinical-stage biotechnology company... .... Led by a management team with... ...serve as a key project management leader... ...an emphasis on CMC knowledge and the... ...based, west coast remote may be... ...experience with biologics or complex modalities... ...Experience supporting late-stage...Remote workWork at officeLocal area- ...discovery, Product Development/ CMC represents the next barrier/... .... The complexity of biological systems, the rigor of regulatory... ...cutting edge programs across early stage, late stage and commercial product... ...principles, model lifecycle management, or deployment of analytical...SuggestedFull timeLocal area
$99.2k - $141.4k
...research and development, manage national laboratories,... ...fibrosis disease biology, inhalation delivery technology... ...leading technical projects, workstreams, or scientific... ....Familiarity with CMC considerations, manufacturability... ...60% in-office and 40% remote, with Monday and...Remote workWork experience placementWork at officeLocal areaFlexible hours$132k - $172k
...Position Summary:The Senior Manager, CMC Regulatory Affairs is... ...activities for biologic products, with a strong focus on late-stage development, Phase 3 programs... ...Operations, and Project Management to ensure alignment... ...is expected to be 100% remote.Total Rewards Offerings...Remote workFull timeTemporary workWorldwide$170k - $230k
...ultimately take advantage of novel biological environments to solve unmet... ...of Biologics Development & CMC to lead the development of... .... This person will initially manage a small team of downstream process... ...program through a major late‑stage regulatory milestone, such as...$150k - $195k
...analytical operations of a biologics product and serves as... ....Responsibilities:Manage and oversee method development... ..., preferably in late-stage drug development.... ...modification and changes to project plans, demonstrating... ...expected to be 100% remote.Total Rewards Offerings...Remote workFull timeTemporary work$150k - $195k
...Operations (Small Molecule CMC) will provide... ...logistics, and lifecycle management of small molecule drug... ...appropriate for advancing a late-stage development asset to... ...internal and external project teams to support CMC... ...expected to be 100% remote.Travere is an EEO/AA/Veteran...Remote workFull timeContract workTemporary work- Director, CMC Project Management (Biologics) About Our Client Our client is stealth stage biopharmaceutical company dedicated to developing next-generation antibody biotherapeutics. They are currently seeking a highly skilled and strategic Biologics CMC Project Manager...Contract work
$209k - $260k
...overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated... ...Operations, the Director Technical (CMC) Project Management will provide technical CMC... ...and leadership across all late-stage development programs...Contract work- ...partnering with a clinical-stage biotechnology company... ...Program Team meetings (Biology, Translational, Regulatory... ..., Clinical Ops, PK/PD, CMC) Shape program strategy... ...spanning preclinical through late-stage development... ...environments Location: Fully remote engagement is possible....Remote work
- ...Alnylam is seeking a highly motivated Sr. Scientist in Delivery Biology to support and advance targeted delivery strategies for... ...just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation...Full timeTemporary workLocal areaFlexible hours
$150k - $195k
...Director, Technical Operations, Biologics Drug Substance Manufacturing... ...substance manufacturing from late-stage clinical development through... ...documentation supporting CMC sections of IND, BLA, and regulatory... ...subjects.Support lifecycle management activities, including process...Contract work- ...CMC Project Manager ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical...Remote workFlexible hours
CMC Lead to drive IND-enabling and late-stage bioproduct development projects. You will coordinate cross-functional teams, manage timelines, and promote the company’s ADC/bioconjugate capabilities with clients...
Remote job- ...an Associate Director of Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing... ..., Clinical, and Supply Chain to meet program milestones for late-stage development and commercial readiness. The role requires 8+...Remote job
- ...seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight for API development and... ...on risk and milestones for small molecule drug products within late-stage development. You will lead technical reviews, ensure process validation...Remote job
- ...Business Development-Biologics, West Coast U.S.... ...science, robust data management, IP security, and quality... ...driving both early-stage (CLD/FIH) and late-stage (Tech Transfer... ...finance, legal, and project management teams to... ...position This is a remote role located within...Remote workContract workLocal area
- Nortekhvac is seeking a Project Manager III to lead project lifecycles from planning through delivery... ..., milestones, and budgets using Stage Gate processes. The role supports Rheem... ...arrangement with in-office Monday-Thursday and remote Fridays, across our sites including...Remote workWork at officeMonday to Friday
$166k - $195k
...Protect Humankind!Vaxcyte is a clinical-stage vaccine innovation company... ...to courageously make the most complex biologics ever attempted to protect humankind.*... ...and decision making.Summary:The Sr. Project Manager, Regulatory CMC will serve as a key contributor to the...3 days per week- ...Director, Technical Operations (Small Molecule CMC) to oversee API development and... ..., clinical manufacturing, and lifecycle management of small molecule drug products, partnering... .... The ideal candidate has 8+ years in late-stage development, with strong experience in process...Remote job
- ...seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and... ...and Supply Chain to ensure milestone alignment and readiness for late-stage development. The candidate will have a BS in a life sciences field...Remote job
$224k - $336k
...Process Development & CMC Lead Location... ...will have significant late-phase development... ...-Thursday, Fridays are remote.**Key Responsibilities:... ...Resource and Portfolio Management: Establish departmental... ...one product through late-stage development, regulatory...Remote workMonday to FridayShift work$176.9k - $246.8k
...channel modulator in late-stage clinical development for... ...of ion channel biology, and expertise in novel... ..., Development Program Management, CMC to join our team. The... ...strategic and operational project management leadership... ...office. We will consider remote locations for exceptional...Remote workTemporary workWork at office2 days per week- ...seeks an experienced analytical chemistry leader to guide late-stage small molecule programs through regulatory filing. The... ...expertise in analytical method development, validation, CMC documentation, and management of external CDMOs. You will serve as the primary technical...
- ...Therapeutics is seeking an Associate Director/Director of Drug Product CMC to lead external manufacturing oversight for mAbs and... ...assessment, lifecycle improvements, and regulatory submissions while managing CDMOs and vendor relationships. #J-18808-Ljbffr Dianthus...Remote job
- ...partner company, who manages all applications... ...is looking for a Project Manager 1, Medical... ...activities from early-stage development... ...across early-stage, late-stage, and post-approval... ...'s degree in Biological Sciences or a closely... ...activities. Remote work opportunity within...Remote workFull timeContract work
- Rheem Manufacturing is seeking a Project Manager III to lead all aspects of the project lifecycle... ...Introduction (NPI) projects and uses Stage Gate processes and PM tools to track milestones... ...US locations, with office Mon-Thu and remote on Fridays. #J-18808-Ljbffr Rheem...Remote workWork at office
- STA Pharmaceutical, a WuXi AppTec company, seeks a Senior Manager/Associate Director of CMC Project Management. This remote role requires EST availability and bilingual English/Mandarin proficiency. You will manage DS/DP projects from proposal to completion, interact with...Remote job
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