- Developing synthetic routes for target molecules, conducting Process Research and Development, and overseeing API process research and development projects to create efficient, scalable, and reliable drug substance manufacturing processes.
- Creating manufacturing routes and strategies for drug substance development, including raw materials and intermediates.
- Offering strategic planning, technical support, and managing contract manufacturing organizations (CDMO's) for the preparation of manufacturing batches and development reports.
- Assisting external parties with technology transfer, process optimization, and validation related to DS manufacturing operations, potentially being present on-site when required.
- Working collaboratively with various departments to ensure compliance with GMP and global regulatory standards.
- Writing and reviewing CMC sections for regulatory submissions (INDs, IMPDs, NDAs, MAAs).
- Providing technical support and documentation for regulatory submission reviews.
- Supervising and leading a team of CMC chemists and supporting staff.
- A Ph.D. in organic chemistry or a related field.
- At least 12 years of experience in process research and development and CDMO management.
- Deep understanding of cGMP requirements pertaining to drug substances.
- Knowledge of drug substance process development for early-stage development, with experience in late-stage development as a bonus.
- Strong organizational and planning abilities.
- Flexibility for domestic and international travel.
- Thorough knowledge of cGMP compliance and ICH guidelines.
- Experience in managing outsourced projects with contractors.
- Excellent leadership, teamwork, and collaboration skills.
- The capability to excel in a fast-paced, entrepreneurial environment while communicating effectively with a diverse team.
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Intern - Media Research & Development
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Adeia California, United StatesCompany Overview: · Adeia (NASDAQ: ADEA) is a publicly traded Intellectual Property Licensing company headquartered in San Jose, CA with approximately 135 employees primarily in North America. Adeia invents, develops, and licenses fundamental innovations that shape the way millio ...
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Research and Development Project Manager
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Kinetica California, United StatesProject Lifecycle Manager - R&D (Food Contract Manufacturing) · Based: Los Angeles, California · Onsite / Full Time · $90,000 - $120,000 · Bonus · 401K · Healthcare Benefits · Kinetica are partnered with a rapidly growing Food Contract Manufacturer and Distributor in Los Angeles, ...
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Director of Research Development
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HealthCare Recruiters International California, United StatesHealthcare Recruiters International is seeking a Senior Director of R&D to join a rapidly growing medical device company in the Silicon Valley region of California. This is a critical role reporting to the CEO as they continue their work to achieve 510k FDA clearance to market th ...
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Research Development Specialist
3 weeks ago
Oxford Instruments Plc California, United StatesAt Oxford Instruments, we enable the world's leading industrial companies and scientific research communities to image, analyse and manipulate materials down to the atomic and molecular level. With a sixty-year history, and fourteen Queen's Awards for Enterprise, our world-class ...
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Senior Research Development Scientist
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Delve Search - Global Search Consultants California, United StatesSenior Scientist-Molecular Assay Development, SF Bay Area · Are you a skilled Senior Scientist with passion for developing and validating NGS/qPCR based molecular diagnostics assays for implementation in CLIA lab and/or for FDA approval? Delve search are working with a high growt ...
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FusionTech Superior, United StatesThe Fraunhofer Society currently operates 76 institutes and research facilities in Germany and is the world's leading organization for applied research. Around employees work on an annual research volume of 3.0 billion euros. · The Fraunhofer Institute for Energy Infrastructure a ...
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Online marketing manager
1 week ago
Aurora Ventures Golden, United StatesOur client, one of the most innovative franchise systems in the Home & Living sector, has big plans for the future and wants to drive digitalization forward. For this, 30 employees at the Hamburg location give their best every day. Do you want to continue the success story as an ...
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JIRA Consultant
2 weeks ago
Sun Life California, United States Temps pleinDescription · de poste: What will you do? · Consult with Agile teams on usage and adoption of Jira, plugins, APIs, workflows · Configure and manage user permissions, groups, and roles in Jira Cloud. · Setup and configure projects, boards, workflows, and issue types. Customize ...
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School Psychologist
4 days ago
Tilly , CA, United StatesTilly Therapy is seeking skilled and empathetic School Psychologists throughout California. We work with a variety of partners. Our goal is to pair you with a position that *aligns with your location, expertise, and career aspirations.* · Apply with us today to connect with a mem ...
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Epidemiologist Associate Director
4 weeks ago
Ivory Systems California, United States**Must be located in PST** · Duties: · Implement observational research studies in-line with a product's Integrated Evidence Plan under the guidance of a Real World Evidence Product Lead. Specific activities include: · Protocol and statistical analysis plan development and repor ...
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Artificial Intelligence Researcher
1 week ago
Stott and May California, United StatesOur client is at the forefront of developing highly intelligent GenAI assistants, revolutionizing the way enterprises harness data solutions. Their mission is to create cutting-edge AI agents that empower businesses to make smarter decisions and drive innovation. As they continue ...
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Deep Learning Scientist
1 week ago
Acceler8 Talent California, United StatesDeep Learning Researcher - Helping Mold the Financial World · Join our innovative research lab dedicated to reshaping financial markets through cutting-edge AI-driven investment systems. We're seeking a talented Deep Learning Researcher to drive advanced research and implement no ...
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Innovative business development manager
1 week ago
vivo California, United StatesJob Responsibilities: · 1. Responsible for trend research in the consumer electronics industry. Output trend insights and analysis of the consumer electronics industry, consumer behavior, user scenarios, and technology development; · 2. Responsible for information insight and ana ...
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Postdoctoral Scientist
1 week ago
Cedars-Sinai California, United StatesJoin Dr. Dmitriy Sheyn and his research group as a Postdoctoral Scientist in the Cedars-Sinai Regenerative Medicine Institute · The Sheyn Laboratory focuses on the development of stem cell therapies for multiple musculoskeletal disorders caused by acute injuries and aging. The p ...
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Senior Manager Pharma Insights
1 week ago
Smith Hanley Associates California, United StatesTitle: Senior Manager Pharma Insights · Location: Greater Los Angeles Area (on-site) · Compensation: $160-180k + bonus, relo, LTI · Contact: Daniel Wilberschied- · On the hunt for a Senior Manager level position leading insights and analytics for a Global Biopharmaceutical compa ...
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Sr Medical Director/Medical Director
4 weeks ago
Meet California, United StatesMeet has partnered with a biotech that is at the forefront of research and development in cortisol modulation, pioneering molecules that regulate cortisol activity at the glucocorticoid receptor (GR). They are seeking a Sr Medical Director/Medical Director to play a pivotal role ...
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DocDelta California, United StatesCompany Description · DocDelta is a global market research and data platform focused on healthcare providers. Our primary market research and data collection solutions provide valuable insights and analytics to researchers, consultants and investors to make informed decisions and ...
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Manager, Strategic Analysis
3 weeks ago
California Energy Commission California, United StatesManager, Strategic Analysis & Engagement Section – Energy Research & Development Division · (Energy Resources Specialist III (Managerial) state classification) · (Telework option available, but hired candidate must reside in California before starting) · Are you an experienced l ...
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Marketing Intern
3 weeks ago
Liner California, United StatesAbout the Role · Liner is an AI research assistant for students and researchers. We are helping millions of academics find reliable information faster on the web. From writing research papers to researching for a capstone project, Liner helps students find and understand relevant ...
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Scientist
2 weeks ago
Bentham Science California, United StatesSeeking Contributors for a Scholarly Thematic Issue in the Journal, "Current Medicinal Chemistry" · Guest Editor: Dr. Joslyn Mangal · Summary · We are looking for researchers (scholarly authors) to contribute papers to the thematic issue titled, "Understanding the Impact of Lifes ...
Senior/Executive Director Process Research and Development - California, United States - STEMSourcing
3 weeks ago
Description
Our client, a successful biotech company based in California, is in search of a skilled and talented individual to join their team. In this dynamic and fully remote position, you will be responsible for:
The ideal candidate will have:
