Director of Developability & Early CMC
Pinetree Therapeutics, Inc
PineTree Therapeutics in Cambridge, MA, seeks a Director of Developability and Early CMC Development to lead analytical method development, developability assessment, and cell line development for monoclonal and multispecific antibodies. You will oversee CRO/CDMO collaborations, guide candidate selection, and drive IND readiness in a fast-growing biotech environment. The role requires senior scientific leadership, experience with analytical and purification technologies, and a track record of #J-18808-Ljbffr Pinetree Therapeutics, Inc
$172.2k - $233k
...experienced leader to serve as Associate Director, CMC Technology Delivery to lead the digital... ...Chain Technology within the Research & Early Development (ReDev) and Technical Operations... ...Qualifications (PPQs)Partner to develop data assets, AI/digital capabilities for...SuggestedFull timeContract workTemporary workLocal areaFlexible hours3 days per week$170.9k - $231.3k
OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for development-stage... ...molecules, biologics, and complex modalities across early- and late-stage development.Plan, review, and...SuggestedFull timeTemporary workWork at officeLocal areaFlexible hours$195k - $330k
...of targeted protein degradation (TPD) to develop medicines that address critical health problems... ...you’ll make an impact:Drive end-to-end CMC program management for mid to late-stage... ...with 10+ years of CMC experience; Sr. Director level requires commensurate additional experience...Suggested$143k - $233k
...regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs. Your Role: With minimal supervision, accountable for developing and leading the execution of regulatory CMC investigational, registration and/or post-approval...Suggested$161.5k - $218.5k
OverviewThe Associate Director, Downstream, Emerging Modalities, is expected to provide technical... ...Proof Of Concept transition by leading CMC team as necessary for the assigned... ...development tradeoffs, and guide programs from early development through Phase I with limited...SuggestedFull timeTemporary workLocal areaFlexible hours$166.4k - $249.6k
...DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across... ...submissions for biologics (INDs/CTAs, NDAs/BLAs/MAAs)Develops and drives global CMC regulatory strategies for assigned programsServes...Full timeSummer workRemote workFlexible hours2 days per week$147.5k - $221.3k
Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness... ...functions, fostering collaboration and knowledge sharing. Develop trusted partnerships with external sites.Drive optimization,...Full timeSummer workRemote workFlexible hours2 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... ...delivery of critical functions as follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational,...Minimum wageLocal areaRemote workWorldwide- ...Relay Therapeutics seeks an experienced CMC regulatory professional to lead chemistry, manufacturing, and control strategy development... ...coordination with minimal supervision. Responsibilities Develop and execute CMC regulatory strategies and global submission plans...
- ...Job Description Description Under the direction of the Early Education Director, the Associate Director of Early Education position is responsible... ...; staff development, supervision and accountability # Develop a weekly schedule for presence in designated classrooms to...Part time
$166.4k - $249.6k
...Associate Director of Regulatory CMC for biologics who will lead global regulatory strategy, author and review CMC submissions for investigational... ...of CMC sections in global regulatory submissions Develop and execute global CMC regulatory strategies for assigned...$136.51k - $204.77k
...Associate Director leading chemistry, manufacturing, and controls strategy for early-stage alpha-emitting radioconjugate programs. Will develop IND-enabling plans, coordinate API and drug product development... ...first-in-human readiness Lead CMC regulatory strategy and author...$136.51k - $204.77k
...Job Title: Associate Director, CMC Lead Introduction to role: Are you ready to lead early-stage CMC strategy that turns precision radioconjugate science into... ...targets and modalities for CMC feasibility and developability to guide investment decisions. Transition...Hourly payTemporary work$154.4k - $242.55k
...innovative and dynamic AI/ML Associate Director with a passion for leveraging... ...and generative protein design.Develop, implement, and deploy... ...portfolio, engaging program teams early to scope computational... ...including Discovery Biology, CMC, and Program Leadership, contributing...Minimum wageLocal areaWorldwide$163k - $225k
...Biogen seeks an Associate Director CMC Asset Lead to oversee end-to-end chemistry, manufacturing, and controls strategy for clinical immunology... ...Operations & Technology role manages cross-functional teams, develops 5-year asset strategies, and ensures efficient supply chain...$161k - $186k
The Associate Director, Market Research and Competitive Intelligence (MRCI), Pipeline and Early Assets will be responsible for recommending, designing, and executing qualitative... ...decades of deep neuroscience expertise to develop medicines designed to help people living with...Work at officeLocal areaFlexible hours3 days per week$228k - $313.5k
...D capability focused on conceiving and developing life-changing treatments for patients by... ...Summary : We are seeking an Executive Director, CMC (Chemistry, Manufacturing & Controls)... ...portfolio from research interface through early and late clinical development. This...Contract work- ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations: South Boston... ...biopharmaceutical company focused on developing transformative gene-based medicines for... ...therapies to patients. As the Regulatory CMC lead for these programs, you will have the...Contract workRemote work
$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 &... ...OPEX) and collaborate with the PO&T Line Functions to develop tactics to improve them. Develop business cases for key...Full timeTemporary workLocal area$141.7k - $173.19k
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living... ...scalable project management, and digital transformation within CMC.The Manager, the CMC Program Operations will serve as the operations...Full time$135.46k - $203.19k
Job Title: Associate Director, External QualityLocation: Boston, MA Hybrid... ...oncology company focused on developing next generation radio... ...multiple pipeline programs entering early FIH trials. In addition, Fusion... ...to regulatory submissions (CMC quality sections) and post-approval...Full timeContract workTemporary work$159k - $219k
...various modalities. This Associate Director of Engineering position provides experiences in early phase to late phase drug... ...medicines to patients. We focus on developing safe, economical, sustainable, cost... ..., including engagement in CMC activities including authoring CMC...Full timeContract workTemporary workLocal area$142.5k - $256.5k
The RoleModerna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and... ...transformative medicines to patients.Here’s What You’ll Do Developing and implementing effective CMC regulatory strategies...Permanent employmentFull timeWork at officeWork from home$142.5k - $256.5k
The Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products,... ...lifecycle. The Associate Director will be responsible for developing global regulatory CMC strategies and collaborating with...Permanent employmentFull timeWork at officeWork from home- Relay Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule programs, develop global submission plans, and coordinate cross-functional teams to ensure regulatory success...
$142.5k - $256.5k
...Moderna is seeking an Associate Director of Clinical Operations to... ...study and/or program objectives Develop operational strategy and clinical... ...required. Experience in early clinical development and immuno... ...functions such as Regulatory, CMC, Biostatistics, Data Management...Permanent employmentWork at officeLocal areaWork from home$170k - $210k
...pathway that has eluded drug developers for decades. Zolucatetide is being... ...and driven Associate Director, Toxicology to lead nonclinical... ...embedded in the discovery and early development organization, with... ...-custody in coordination with CMC and Pharmaceutical Sciences....Contract workInterim roleLocal areaShift work- ...Kymera Therapeutics seeks a Director or Senior Director to manage chemistry, manufacturing, and controls programs for mid-to-late-stage... ...cross-functional coordination, regulatory submission support, and CMC strategy for programs advancing through clinical and commercial...
$167k - $300.7k
The RoleCMC is seeking a dynamic and experienced Director, CMC Stability to lead an end-to-end stability function spanning non-clinical-enabling... ...oriented leader who can establish effective operating models, develop talent, and influence across Analytical Development, Quality,...Permanent employmentFull timeWork from home$210k - $290k
...highly collaborative Senior Director to lead Protein Analytics & Biophysics... ...protein analytics, developability, and protein-protein interaction... ...Learning, Biology, and CMC/Tech Ops, and translating an... ...Discovery, Candidate Selection, and early Development, including...Shift work
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