- Together with SVP Product Development:
- develop and implement comprehensive plans to meet CMC needs that include drug substance, drug product and analytics
- plan and execute drug product manufacturing activities for the company to ensure regulatory compliance, quality and timelines are met
- plan, develop and employ project-specific CMC resource and budget plan to ensure agreed goals and spending targets are met
- participate in formulation research and product development of company pipeline product opportunities
- Work with senior management and other project team members to select and qualify CMOs/CROs
- Communicate effectively and transparently with functional heads within pharmaceutical development and other company stakeholders (Quality, Toxicology/DMPK, Clinical/Regulatory, Operations, Project, etc.)
- Provide oversight during manufacture of drug products at CMOs
- Liaise with analytical contract laboratories to oversee shipping and release clinical trial supplies and to monitor drug product stability as required for clinical studies and product registration
- Work with packaging/labeling CMO to maintain adequate clinical supply inventory to support ongoing clinical studies
- Provide technical expertise to contribute to new project selection for the company
- Contribute significantly to lead selection/optimization, formulation development/process and clinical development of pipeline asset(s) selected for program advancement
- Provide support to CMC writing for regulatory submissions, board update, due diligence, etc.
- A PhD or advanced degree in Pharmaceutics, Chemical Engineering or equivalent with 10+ years of industrial experience
- Direct experience in formulation development and manufacturing of sterile solution-based drug products (experience in inhalation devices is a plus)
- Direct experience in managing clinical labeling and packaging of clinical supplies with CMOs
- Experience in managing CMC/analytical activities at different stages of drug development programs
- Have authored relevant pre-IND, IND and NDA CMC/analytical sections
- Preference will be given to candidates with direct CMC/analytical experience in approved inhalation drug products
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Food Product Developer
2 days ago
Actalent Seattle, United States Full timeDescription: · As a product developer on the Product & Innovation Bakery & Prepared team, you will work closely with our experienced team of developers in the Starbucks R&D Kitchen. With a passion for creating distinct and memorable food experiences for our customers you will dev ...
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Product Development Assistant
1 week ago
Actalent Seattle, United States Full timeDescription: · This is an opportunity to help in the creation and development of new beverages for our large food and beverage client in Seattle. This posting is for a role in beverage R&D, for the creation and optimization of beverages for our cafés and/or alternate business cha ...
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Food Product Developer Assistant
2 days ago
Actalent Seattle, United States Full timeDescription: · This is an opportunity to help in the creation and development of new beverages for our large food and beverage client in Seattle. This posting is for a role in beverage R&D, for the creation and optimization of beverages for our cafés and/or alternate business cha ...
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Product Development
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PwC Seattle, United StatesSpecialty/Competency: · Operations · Industry/Sector: · Not Applicable · Time Type: · Full time · Travel Requirements: · Up to 80% · A career in Product Development and Manufacturing, within Operations Consulting, will provide you with the opportunity to help organizations un ...
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Developer -Products
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Product Development Assistant
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Product Development Chemist
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Product Development Assistant
1 week ago
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Product Development Chemist
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Product Development Engineer
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Morgan Stanley Seattle, United StatesThis service is set to disconnect automatically after {0} minutes of inactivity. Your session will end in {1} minutes. · Click OK to reset the timer to {0} minutes. · You have been signed out. · This service is set to sign out after {0} minutes of inactivity. · 3D Systems provi ...
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Product Developer/Engineer
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Filson Seattle, United StatesJob Description · Job DescriptionIn 1897 C.C. Filson began outfitting prospectors headed for the Gold Rush with tools and apparel strong enough for the toughest spots on earth. More than 100 years later, Filson remains committed to providing pioneers of all fields around the worl ...
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Engineering Manager, Developer Productivity
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DocuSign Seattle, WA, United StatesWith intelligent agreement management, Docusign unleashes business-critical data that is trapped inside of documents. Using Docusign's Intelligent Agreement Management platform, companies can create, commit, and manage agreements with solutions created by the #1 company in e-sign ...
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Global Product Development and Supply
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Omni Inclusive Seattle, United States*Job Title: Project Manager · *Location: Seattle-Dexter, WA **Hybrid** · *Top Skills: · - 8+years of project management experience in supply chain or manufacturing environment (pharmaceutical/regulated industrypreferred). Aerospace, Food & Drug. Microsoft Office Suite, Smartsh ...
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Money Fit by DRS Seattle, United States3+ years of non-internship professional software development experience · 2+ years of non-internship design or architecture (design patterns, reliability and scaling) of new and existing systems experience · Experience programming with at least one software programming language · ...
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TiNDLE Foods Seattle, United StatesAbout the Company · At TiNDLE, we believe a new era of food is coming. An era where we can enjoy delicious foods, without giving up any part of the memorable and delightful experience of dining on our favorite foods. We don't want anyone to have to change what they eat; we just w ...
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American Advertising Federation Seattle, United StatesProduct Marketing Manager, Developer Marketing, Google Cloud · XNote: By applying to this position you will have an opportunity to share your preferred working location from the following: Seattle, WA, USA; New York, NY, USA; San Francisco, CA, USA; Sunnyvale, CA, USA.Minimum qu ...
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Amazon Web Services (AWS) Seattle, WA, United StatesAmazon Web Services (AWS) is the world's most comprehensive and broadly adopted cloud platform, offering over 200 fully featured services from data centers globally. Millions of customers—including the fastest-growing startups, largest enterprises, and leading government agencies ...
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Amazon Web Services (AWS) Seattle, WA, United StatesDescription · Amazon Web Services (AWS) is the world's most comprehensive and broadly adopted cloud platform, offering over 200 fully featured services from data centers globally. Millions of customers—including the fastest-growing startups, largest enterprises, and leading gove ...
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Join Our Talent Community Seattle, United StatesYour Impact · As a senior engineer on the team, you will be intimately involved in the architecture decisions that will shape this product. You live and breathe cloud services that require high availability and fast, consistent performance. You love working with the latest open s ...
Associate Director/Director, Product Development - Seattle, United States - NWRPros
Description
Our Client is seeking a highly motivated individual at the Associate Director/Director level to join its Product Development team. This individual will play a key role in advancing the Companys lead AP01 program and expanding the Company product pipeline to treat rare lung diseases. This is a remote position and will be reporting to the Senior Vice President, Product Development.
Key Responsibilities:
Associate Director/Director, Product Development professionals in Seattle
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Saad Siddiqui
PRODUCT MANAGEMENT LEADER
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Lisa Nicon
Director of Events/Production Manager
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Jean-Yves Piton
B2B/B2C Sales Leader
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Troy Sturdevant
Banking & Business Professional
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warren lubow
Business sales executive leader
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Jay Yoo
Director of Information Technology