OSD Drug Product Development Lead (NDA & Process)
Otsuka America Pharmaceutical Inc.
Otsuka America Pharmaceutical Inc. is seeking a Director for Drug Product Development in Boston, MA. The successful candidate will lead late-stage development for oral solid dosage forms, ensuring compliance and robust drug product design. The role also includes oversight of NDA submissions and collaboration with external manufacturing partners. This position requires a PhD or MS in relevant fields and 10-12 years of related experience. Benefits include comprehensive health coverage and retirement plans. #J-18808-Ljbffr Otsuka America Pharmaceutical Inc.
$186.49k - $278.88k
The Director, Drug Product Development will lead late‑stage development and NDA‑enabling activities for oral solid dosage form (OSD) drug products. This role is responsible for execution of formulation, process development, scale‑up, validation, and regulatory deliverables...SuggestedTemporary workLocal areaFlexible hours- Otsuka America Pharmaceutical Inc. is seeking an Associate Director for Drug Product & Process Development. This role involves leading late-stage drug product development, regulatory filings, and lifecycle management, ensuring compliance and robust process establishment...Suggested
$169.22k - $253k
The Associate Director, Drug Product & Process Development, will provide technical and strategic leadership for... ...regulatory filings (IND amendments, NDA/MAA), and post‑approval lifecycle... ...Drug Product & Process Development Lead late‑stage drug product development activities...SuggestedTemporary workLocal areaFlexible hours- ...Therapeutics is seeking an experienced professional to join their drug product development team in Cambridge, Massachusetts. The role involves overseeing the design and development of drug formulation processes, ensuring product quality, and managing regulatory submissions...Suggested
- ...transforming your career. Senior Director, Bioprocess / Process Development - Pivotal Drug Substance What you will do In this leadership role, you will... ...in Cambridge, MA and/or Thousand Oaks, CA, you will lead and develop a multi‑site organization of 30+ scientists and...SuggestedFlexible hours
- ...a candidate to oversee experiments for lipid nanoparticle drug product processes. The successful applicant will develop innovative processes... ...have a relevant degree, proven experience in drug product development, and excellent communication skills. The position offers...
$190k - $210k
...revolutionize small‑molecule therapy development. Our lead program, RAP‑219, first... ...Associate Director of Drug Product Development to join our CMC... ...on late‑stage development, NDA submission, and anticipated... ..., and inspection‑ready processes. Responsibilities Lead drug...Work at officeLocal area- ...an integral part of Relay’s drug product development team supporting Relay's... ...formulation and manufacturing processes that ensure product quality... ...submission documents (IND, IMPD, NDA, briefing packages, etc.),... ...of drug product batches by leading technical reviews of batch...Immediate start
$182k - $275k
...Opportunity Overview As Director, Drug Product - Formulation, you will lead the global strategy and... ...of oral drug product development across all phases, from... ...plans. Direct process development, scale-up, and... ...regulatory submissions (IND, CTA, NDA, MAA), including...Work at office- ...Requirements At least 10 years of drug development experience spanning... ...to the Global Program Lead (GPL), to shape and deliver the Target Product Profile (TPP) and... ...Supports GPT annual objective processes and budget planning... ...(IND/CTA through NDA/BLA/MAA/JNDA/ NDA China...
- ...Manufacturing Science & Technology (MS&T) - Drug Product. You will provide technical leadership for sterile drug product processes, ensuring compliance and operational efficiency... ...and offers a hybrid work model. You will lead cross-functional teams, manage technology transfers...
$138.7k - $208.1k
...Science & Technology (MS&T) - Drug Product Sterile Manufacturing... ...drug product manufacturing processes across clinical and commercial... ...Serve as the MS&T technical lead for sterile drug product manufacturing... ..., Quality, Process Development, Regulatory, and Supply Chain...Remote work$170k - $195k
...career in science, clinical development, commercial strategy, and... ...Responsibilities Combination Product Development: Lead development of combination... ...systems, and fill‑finish processes. DHF Ownership & Compliance... ...and inspection readiness. Drug Product Considerations: Apply...Work at officeWorldwideFlexible hours- Associate Director, Sterility Assurance, Drug Product Company: EFOR Group Industry: Life... ...profile About EFOR Group EFOR Group is a leading life sciences consulting and... ...leader with strong expertise in aseptic processing, contamination control, environmental monitoring...Full timeContract work
$138.7k - $208.1k
...Senior Manager for Manufacturing Science & Technology in Boston, MA. This role provides technical leadership for sterile drug product manufacturing processes in both clinical and commercial settings. The manager will oversee process transfers, validations, and continual...- Zealand Pharma U.S., Inc. is seeking a Global Head of Drug Substance - Senior Director in Cambridge, MA. The ideal candidate will establish and lead a Peptide Process Development lab and provide strategic direction for Drug Substance functions, focusing on peptide drug...
$197.1k - $266.7k
...PeptideOligonucleotide Conjugate (POC) Process Development will provide technical leadership for the... ...located in Cambridge, MA. Responsibilities Lead process development, optimization, scale... ...and process characterization of peptide‑drug conjugates and/or oligonucleotide...Full timeTemporary workLocal areaFlexible hours- A leading biopharmaceutical organization is seeking an Associate Director of Downstream Process Development to oversee purification processes for biologic drug substances. The ideal candidate will have significant experience in downstream process development and lead a...Full time
- ...MA (and Thousand Oaks, CA) seeks a Senior Director to lead drug-substance bioprocess development, scale-up, and characterization, enabling programs from... ..., and other biologics, with responsibility for process transfer, lifecycle management, and regulatory filings...
- ...conditions where growth factor-targeted drugs can play a transformational role.... ...technically strong Senior Director of Drug Product Development to lead formulation and drug product... ...experience in formulation development, process development, tech transfer, and commercial...
- ## Head of Drug Substance & Analytical DevelopmentApplylocations... ...deep expertise in peptide process chemistry and leading high-performing teams? If... ...of peptide drug substance development at a fast-growing biotech,... ...from development to production**Your profile** The ideal...Local areaImmediate start
$214k - $249.8k
Ironwood Pharmaceuticals is a leading global gastrointestinal (GI)... .... We are pioneers in the development of LINZESS® (linaclotide), the... .... The Director, Head of Drug Product Analytical Operations leads... ...development, technical transfers, process validation, regulatory...- Essential Functions Lead and develop the Analytical Drug Product team. Oversee outsourced analytical development at CROs/CDMOs (phase-appropriate strategy, quality, governance,... ...injectable support; packaging; lifecycle; Phase 3; process validation; launch readiness; commercial...
- A leading biotechnology firm is seeking an experienced Senior Program Manager to oversee drug development processes. The role requires at least 10 years of experience in drug development project management, ideally with a background in various therapy areas. Candidates...
- Associate Director, CMC Product Development - Small Molecule About Beeline... ...developing and delivering category‑leading precision therapies to... ...formulation development, drug product process development, and... ...regulatory submissions (IND, IMPD, NDA) including formulation descriptions...Contract workLocal areaImmediate start2 days per week
- Rhythm Pharmaceuticals Inc. is seeking a Director, Drug Product - Formulation to lead the global strategy and execution of oral drug product development. This role requires overseeing the development of scalable formulations and ensuring high-quality regulatory submissions...Work at officeRemote work
$122k - $179.3k
...in the future. The Autodesk Product Design and Manufacturing Solutions... ...each phase of a product's development lifecycle — from design and... ...Cloud platform and market‑leading specialist products.... ...CAM machine simulation, post processing, manufacturing content libraries...Temporary workWork at office- Associate Director, Downstream Process Development We are proud to be partnering with a leading biopharmaceutical organization on an exciting search for an Associate... ...on developing purification processes for biologic drug substances while playing a key role in guiding strategic...Full timeWork at office
- Beeline Medicines in Durham is seeking a Director of CMC Product Development - Biologics to lead the end-to-end development strategy for biologics drug product candidates. This role involves close collaboration with various teams and external partners to drive successful...2 days per week
- Beeline Medicines in North Carolina is seeking an Associate Director for CMC Product Development in small molecules. You will oversee formulation and drug product process development, collaborating with external partners to ensure successful manufacturing. The role demands...
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