Director, Drug Substance CMC (Small Molecules)
Selby Jennings
EPM Scientific is seeking a Director of Drug Substance CMC to lead the development of innovative small molecule therapeutics in New York. In this critical leadership role, you will drive drug substance strategy and ensure compliance with regulatory expectations while collaborating with cross-functional teams. The ideal candidate will have a PhD or MS in a relevant discipline and 8+ years of experience in small molecule development. This position requires strong leadership and a solid understanding of external manufacturing processes. #J-18808-Ljbffr EPM Scientific
$175k - $215k
...Role Axsome Therapeutics is seeking an Associate Director/Director, Technical Operations - Drug Substance (Small Molecules) to provide technical leadership across the... ...candidate will serve as a key technical leader within CMC, partnering closely with external CDMOs and...SuggestedLocal areaRemote work3 days per week$175k - $215k
Axsome Therapeutics, Inc. is hiring an Associate Director/Director, Technical Operations in New York City. This role focuses on overseeing drug substance manufacturing, ensuring regulatory compliance, and providing technical leadership. Ideal candidates have advanced degrees...Suggested- The Regulatory Affairs CMC will lead global CMC regulatory strategies... ...regulatory requirements. The Director will serve as the CMC... ...Knowledge Deep understanding of small molecules development (Biologics, gene... ..., cell therapy, or antibody-drug conjugate experience is a...SuggestedContract work
$176.4k - $228.25k
...development and implementation of CMC regulatory strategy for small molecule investigational drugs in global Phase 1-3 clinical... ...team meetings, providing drug substance or drug product recommendations... ...The Team You’ll Join As Manager/Director CMC Regulatory Affairs you will...SuggestedLocal areaRemote workWork from homeWorldwide$175k - $190k
...are currently looking for an Associate Director, Drug Product Development & Manufacturing in... ...development and manufacturing operations for small molecule pharmaceutical programs in a fully... ...and manufacturing. Author and review CMC sections for regulatory submissions and...SuggestedRemote workFlexible hours$177k - $235k
...radically more efficient drug development.... ...Sr. Manager/Associate Director of Analytical Development... ...Quality Control to join our CMC team. This role will... ...ability to flex between small molecule and biologics programs... ...validation of drug substance and drug product analytical...Contract workWork at officeRelocationFlexible hours$150k - $195k
...Position Summary The Associate Director, Technical Operations QC is... ...colleagues in Analytical, CMC, Quality, and Regulatory groups... ...to commercialization of a small molecule drug product for a rare disease... ...activities in support of drug substance and drug product...Contract workTemporary workRemote work$157.2k - $256.6k
...As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and... ..., licensure, and marketing of drugs and/or biologics. • Lead and... ...Proven track record supporting small molecule drugs and/or biological...Work at officeLocal areaRemote workWorldwideRelocation package3 days per week- ...activities in North America within STA, WuXi’s CMC small molecule development and manufacturing division.... ...strategy to increase small molecule Drug Product, API and intermediate sales in... ...is remote and can be hired at the Director or Associate Director level, depending...Remote workFlexible hours
$163.47k - $214.55k
...treatment of multiple myeloma. Legend Biotech is seeking an Associate Director, CMC Project Management as part of the Technical Development team... .... Cell/Gene Therapy experience preferred Expertise in CMC drug development pertinent to cell/gene therapy manufacturing...Permanent employmentFull timeContract workTemporary workLocal areaWorldwideFlexible hoursShift work- ...Manager of Analytical Development and Quality Control. This role will lead the development and validation of analytical methods for small molecule and biologics while overseeing vendor management and stability studies. An ideal candidate will have a Master’s or Bachelor's...Work at office
$167k - $230k
Associate Director, Bioanalytical Development About Formation Bio Formation Bio is a tech... ...by radically more efficient drug development. Advancements in AI and drug... ...and delivery for assigned programs across small molecules and biologics, aligned to clinical questions...Work at officeRelocation$150k - $220k
Join to apply for the Associate Director / Director - Lab Automation role at Excelsior Sciences This range is provided by... ...00.00/yr Excelsior Sciences of New York is transforming small molecule therapeutic drug discovery with the use of modular chemistry, to make better...Local areaFlexible hours$111.2k - $126.9k
...Overview Senior Associate, Product Manager-Small Business Bank Product Management at Capital One is a booming, vibrant craft... ...applicable federal, state, and local laws. Capital One promotes a drug-free workplace. Capital One will consider for employment...Full timePart timeLocal area- Definium Therapeutics is seeking an Associate Director, Drug Product Development to lead drug product development in a remote setting. You will be instrumental in overseeing outsourced manufacturing operations, contributing your expertise in cGMP and technical oversight...Remote jobFlexible hours
$170k - $230k
...any protein, provide national resilience to drug shortages and de‑risk complex supply... ...exceptional Head of Biologics Development & CMC to lead the development of therapeutic proteins... .... This person will initially manage a small team of downstream process development and...- ...Requirements MD required More than 5 years total relevant experience in PV and/or relevant medical field or equivalent (industry experience in drug safety including significant experience with PSURs/ DSURs/ (d)RMPS; or in clinical development with demonstrated achievements in...Full time
$88.8k - $101.3k
...Associate, Process Manager – Treasury Management Implementation The Small Business Bank Senior Associate, Process Manager - Treasury... ...discrimination in compliance with applicable federal, state, and local laws. Capital One promotes a drug‑free workplace. #J-18808-Ljbffr...Local area$130k - $200k
...Join to apply for the Associate Director Regulatory Affairs role at... ...mainly to novel biologics (large molecule/infectious disease, autoimmune... ...teams to advance the drug development program. This is a... ...Gene Therapy Associate Director, CMC Regulatory Affairs United States...Full timeTemporary workWork at officeLocal areaRemote workFlexible hours$176k - $236k
General Description The Director, Global Regulatory Project Management (Director, Global... ...regulatory strategies across the global drug development lifecycle. This role combines... ...regulatory submissions, including both small molecules and biologics, with significant global exposure...Work at officeWorldwide- Senior/Executive Director, Drug Product MS&T The Senior/Executive Director, Drug Product MS&T is... ...and DoE. Experienced in authoring CMC sections for commercial regulatory filings... ...attitude to join a dynamic, team-based, small but growing biotech with a diverse range...Contract workFor contractorsRemote work
- Otsuka Pharmaceutical Co., Ltd is searching for an Associate Director, Drug Product & Process Development to lead late-stage drug product development... ...include overseeing development activities, serving as the CMC lead for regulatory filings, and mentoring junior staff. An...
- ...development assets, we are seeking an Associate Director, Program Management to provide leadership... ...Facilitate collaboration among Research, CMC, Clinical Development, Regulatory Affairs,... ...program or project management supporting drug development programs. Demonstrated success...Contract work3 days per week
- ...manufacturing of oral solid dosage pharmaceutical drugs. Discover Impactful Work Patheon, by Thermo... ...companies of all sizes. Drug substances and drug products. Development and manufacturing. Small and large molecules. Sterile, oral solid and softgel dosage forms...Work at office
- Associate Director / Director - Drug Safety Physician (Contract) We are supporting a growing biotech as they build out their Drug Safety and Pharmacovigilance function at a key stage in their development. This is a 12 month contract with strong potential to extend or...Permanent employmentContract work2 days per week
- ...University of Texas MD Anderson Cancer Center is looking for a Director of Cheminformatics to integrate data workflows in an emerging biotech... ...platforms and enhancing data management practices in drug discovery. The ideal candidate will possess a significant background...Remote job
- A biotech innovation firm in New York seeks an Associate Director / Director - Lab Automation to lead the design and implementation of automated systems in drug discovery. This position requires extensive hands-on experience with lab automation and the ability to mentor...
$68.2k - $102.3k
...State is currently seeking an Associate Director in the Office of Foundation Relations. As... ...ranked among the lowest-stress and safest small cities in the country, with excellent public... ..., such as those concerning alcohol and drug use, crime prevention, the reporting of...Full timeWork experience placementWork at officeRemote workFlexible hours- ...to drive strategic growth in small molecule API CDMO services across... ...chemistry, HPAPIs, controlled substances, and complex synthesis . Serve... ...In-depth understanding of CMC development , IND-enabling activities... ...0,000.00 3 weeks ago Senior Director, Business & Corporate...Full timeContract workRemote work
$167k - $210.3k
...a rare disease. Overview The Associate Director (AD), US Marketing, is responsible for the... ...orphan, rare disease, and/or specialized drug(s). Demonstrated success in developing and... ...and/or sales operations; experience in a small but fast‑growing, entrepreneurial...Temporary workWork at officeLocal area
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