Director, Analytical Stewardship (CMC)
Celea Therapeutics, Inc.
Celea Therapeutics, Inc. is seeking an experienced, strategic, and hands-on Associate Director/Director, Analytical Steward, CMC to serve as the end-to-end technical owner for analytical activities across the product lifecycle. Based in Boston, this hybrid role drives phase-appropriate development, regulatory submissions, and lifecycle management for drug substances and products. You will lead analytical strategy, oversee CMOs/CDMOs, and ensure inspection readiness while collaborating with #J-18808-Ljbffr Celea Therapeutics, Inc.
$190k - $205k
Associate Director/Director, Analytical Steward, CMC About Celea Therapeutics Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for “sky,” our name reflects our mission to rise...SuggestedContract work- ...and execute the IT solutions roadmap for CMC digital transformation. Oversee... ...transfer of Drug Substance/Drug Product/analytical methods and data. Enable creation, transformation... .... Establish process data governance/stewardship and publish data products to support analytics...SuggestedFlexible hours
$160k - $240k
...inclusivity, so that our people are valued, seen, and heard.How you’ll make an impact:As the Associate Director, Analytical Development, you will contribute to CMC activities supporting mid and late phase clinical development of Kymera’s small-molecule protein degraders...SuggestedContract work$172k - $202k
...applicable regulatory guidelines. You will support the life cycle management of the analytical methods and region-specific specifications at the commercial stage. You will work with CMC technical SMEs, QA and Regulatory to ensure regulatory submission readiness, including...SuggestedWork at officeLocal areaRemote work1 day per week$195k - $330k
...How you’ll make an impact:Drive end-to-end CMC program management for mid to late-stage... ...spanning drug substance, drug product, analytical, quality, regulatory, and supply chain workstreams... ...15+ years (M.S.) of CMC experience; Sr. Director level requires commensurate additional...Suggested- Overview The Associate Director, Downstream, Emerging Modalities, is expected to provide technical... ...Proof Of Concept transition by leading CMC team as necessary for the assigned... ...closely with Research, Process Sciences, Analytical Development, Formulation Development, Regulatory...Full timeTemporary workLocal areaFlexible hours
$176.9k - $246.8k
...operations. About The Role We are seeking an Associate Director/Director, Development Program Management, CMC to join our team. The Associate Director/Director,... ..., and related project management tools. Strong analytical, facilitation, problem-solving, written...Temporary workWork at officeRemote work2 days per week$180k - $205k
...LinkedIn. Position Overview: Reporting to the Director, Product Development, the Associate Director, Analytical Development is responsible for leading the... ...contract laboratories and manufacturing partners. CMC Regulatory Support Author and review analytical...Contract workLocal area- Associate Director/Director, CMC (Late Stage Development, Bioprocess) 2-3 Days Per Week Onsite in Boston, MA Full-Time, Permanent We are seeking... ...breadth to integrate across drug substance, drug product, analytical, Quality, Regulatory, and Supply Chain interfaces. The...Permanent employmentFull timeShift work2 days per week3 days per week
$154.4k - $242.55k
...Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s... ...and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust...Minimum wageTemporary workLocal areaRemote workWorldwide$197.91k - $210.51k
...mediated diseases can live life fully. Job Summary The Associate Director, CMC Product Development - Small Molecule is a senior... ...Oversee drug product stability programs in collaboration with Analytical Development, including protocol design, shelf‑life determination...Contract workLocal areaImmediate startFlexible hours2 days per week$193.1k - $289.7k
Job DescriptionGENERAL SUMMARY:The CMC Statistics Director (Scientific Fellow) provides strategic and technical leadership for the application... ...the product lifecycle, including process development, analytical development, manufacturing, process validation, continued...Full timeSummer workRemote workFlexible hours2 days per week$210k - $290k
...seeking a scientifically bold, highly collaborative Senior Director to lead Protein Analytics & Biophysics within our Therapeutics division. This... ...Technology, Data Sciences, Machine Learning, Biology, and CMC/Tech Ops, and translating an ambitious scientific vision...Shift work- The Director of Analytical Development will lead and build analytical strategies to support the development, characterization, and lifecycle management... ...CDMO) resources, and serve as a key technical authority for CMC-related analytical activities. Responsibilities: Strategic &...
$180k - $195k
Associate Director, Quality Assurance - CMC Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel... ...experience managing external CMOs Strong organizational, analytical, and problem-solving skills, with the ability to manage...$136.51k - $204.77k
Job Title: Associate Director, CMC Lead Job Title: Associate Director, CMC Lead Introduction to role: Are you ready to lead early-stage... ...and data packages for IND/IMPD submissions. API/Drug Product/Analytical Integration: Coordinate API, drug product, and analytical...Hourly payTemporary work- ...commercial operations. About the Role: We are seeking an Associate Director, CMC, Drug Product, to join our team. The Associate Director, CMC,... ...packaging for clinical development in collaboration with Analytical colleagues. Evaluate, recommend, and manage qualified CROs...Contract workTemporary workWork at office2 days per week
$170k - $195k
Description Of Role Centessa’s CMC group is currently seeking an (Associate) Director of Drug Product within the CMC group to support our early stage programs... ...clinical and commercial scale. Proficiency with analytical and solid-state characterization techniques, including...Full timeContract work$173k - $285.33k
...and improving patient outcomes. What You'll Do As a Director/Senior Director, CMC Drug Substance Development, you will be an integral part... ...discovery, non-clinical development, formulation development, analytical development, Quality Assurance, and CMC Regulatory...- ...About the Role: As Associate Director, AS&T Projects & Strategy, you will play... ...Antibody-Drug Conjugates (ADCs) within the Analytics, Science & Technology (AS&T) organization... ...network within the cross-functional late-stage CMC team, helping drive development programs...Hourly pay
$145k - $240k
...people are valued, seen, and heard.How you’ll make an impact:We are seeking a highly motivated Senior Manager or Associate Director, Feasibility Analytics & Insights to serve as the analytical and technical lead within Clinical Trial Planning and Feasibility. This...$162k - $223k
About This Role The Field Analytics and Reporting Lead will be responsible for key field analytics projects, KPI and reporting design including developing key insights to drive our business strategy, specifically our brand execution strategy. Working both reactively and...Full timeTemporary workLocal area$162k - $223k
...hybrid role and will require frequent on-site presence at our Cambridge MA facilityAbout This Role:As the Associate Director, Integrated Insights, Analytics and Market Research you will be a pivotal member of the US Decision Sciences team supporting our Alzheimer's...Full timeTemporary workLocal area- ...leader to serve as Associate Director, Laboratory Informatics Platforms... ..., evolution, and operational stewardship of core laboratory... ...Early Development (ReDev) and CMC.The Associate Director will lead... ...platforms evolve to support future analytics and AI-driven use cases.Key...Full timeTemporary workLocal areaFlexible hours
$148.5k - $214.5k
Job Title: Associate Director, US Consumer AnalyticsLocation: Cambridge, MA or Morristown, NJAbout the Job: The Associate Director, US Consumer Advanced Analytics, will be responsible for applying data, analytics, and measurement capabilities to improve consumer and patient...Full time$160k - $190k
...beginning of building out our US Neurology franchise and preparing for our first launch in Neurology.Role Summary The Associate Director, Neurology Analytics will report into the Senior Director of the Strategic Business Insights for Neurology within the US Corporate Strategy,...Temporary workWork at officeFlexible hours2 days per week3 days per week$154.4k - $242.55k
...you and empower you to shine? Join us as an Associate Director, Separation Sciences, Biologics Analytical Development in our Lexington, MA office.At Takeda, we... ...questions.Author and review analytical content for CMC documents and support global filing activities in all...Minimum wageWork at officeLocal areaRemote work- ...three decades of experience helping life sciences companies optimize their commercialization through strategic insight, advanced analytics, and technology. From developing go-to-market strategies and building foundational data analytics infrastructures to leveraging artificial...Permanent employmentWork at officeRemote workFlexible hours
$163k - $225k
...Operations and Technology (PO&T) Division is looking to hire a CMC Asset Lead. This Associate Director level Asset Lead is a member of the Asset Development... ...&T Asset Team including representatives from process/analytical development, manufacturing, quality, supply chain,...Temporary workLocal area- ...to the Associate Vice President of Advancement, the Director of Donor Relations and Stewardship (“Director”) leads the development and execution of the... ...and sensitive data. Demonstrated problem solving, analytical, and strategic decision‑making skills. Customer service...Hourly payTemporary workWork at officeRemote workFlexible hoursNight shiftWeekend work
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