- Accountable for the design, development, and characterization of phase appropriate solid oral dose drug product formulations, packaging, and manufacturing processes to successfully support clinical studies.
- Leading the cGMP drug product manufacturing and packaging activities at CMOs and oversight in close partnership with quality.
- Lead late-stage drug product development activities including scale-up, design of experiments (DOEs), risk assessments, and development of the integrated control strategy in partnership with other CMC functional areas, Quality, Regulatory Affairs, and Manufacturing.
- Leading the developability assessment of new candidates, preclinical formulation, preformulation, and discovery pharmaceutics studies including API form selection and characterization to nominate a suitable form for development, troubleshooting, and 'defining the path' for new drug candidates.
- Authoring CMC sections of regulatory filings and participating in regulatory agency interactions.
- Ph.D. or M.S. in Chemical Engineering or relevant scientific discipline with at least 10 years of experience in formulation and drug product development and track record of progressing assets from INDs to MAAs.
- Strong understanding and extensive hands‐on experience in early- and late-stage drug product process development. In-depth understanding of formulation development best practices & trends.
- Proven experience in the generation of relevant regulatory sections of IND filings.
- Excellent problem-solving and decision-making skills with the ability to quickly adapt to changing program needs
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Associate Director, Formulation and Drug Delivery
Found in: Lensa US 4 C2 - 2 days ago
Astrix Inc South San Francisco, United StatesOur client is a clinical stage biopharmaceutical company dedicated to improving patients' lives. They develop multiple precision medicines targeting hallmark cancer resistance mechanisms. · Title: Associate Director, Formulation and Drug Delivery · Location: South San Francisco, ...
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Associate Director, Formulation and Drug Delivery
Found in: Lensa US 4 C2 - 1 day ago
ORIC Pharmaceuticals Inc South San Francisco, United States· ORIC is a research-driven company dedicated to discovering and developing novel therapies that can Overcome Resistance In Cancer. Our collaborative, empowering culture gives scientists the authority, responsibility, and support to do cutting-edge work on therapies for treatmen ...
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associate director, formulation and drug delivery
Found in: Careerbuilder One Red US C2 - 19 hours ago
Oric Pharmaceuticals, Inc. San Francisco, CA , USA, United StatesORIC is a research-driven company dedicated to discovering and developing novel therapies that can Overcome Resistance In Cancer. Our collaborative, empowering culture gives scientists the authority, responsibility, and support to do cutting-edge work on therapies for treatment-r ...
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Associate Director, Formulation and Drug Delivery
Found in: Jooble US O C2 - 4 days ago
Oric Pharmaceuticals, Inc. San Francisco, CA, United StatesORIC is a research-driven company dedicated to discovering and developing novel therapies that can Overcome Resistance In Cancer. Our collaborative, empowering culture gives scientists the authority, responsibility, and support to do cutting-edge work on therapies for treatment-r ...
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CRNA - Oakland - 32 hour
Found in: SonicJobs Direct Apply US - 3 days ago
Kaiser Oakland, United StatesJob Summary: · Selects and administers intravenous, spinal and other anesthetics prior to and during surgical or medical procedures, as a member of the anesthesia care team and in accordance with Kaiser Permanente policies and procedures. Monitors patient reactions and vital sig ...
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Associate Director, Clinical Supply Chain
Found in: Appcast US C2 - 22 hours ago
DSJ Global South San Francisco, United States2-3 days onsite in SF REQUIRED · About: · We are currently looking for an Associate Director of Supply Chain to oversee the supply chain operations for our innovative clinical programs. This role entails establishing and managing supply and demand planning processes, coordinatin ...
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Associate Director, Clinical Supply Chain
Found in: Appcast US C2 - 6 days ago
DSJ Global South San Francisco, United StatesAbout: · We are currently looking for an Associate Director of Supply Chain to oversee the supply chain operations for our innovative clinical programs. This role entails establishing and managing supply and demand planning processes, coordinating clinical orders, and ensuring s ...
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Device Engineer III
Found in: Appcast US C2 - 22 hours ago
The Fountain Group South San Francisco, United StatesPay: $ · Length – 1 year contract (available for extension/conversion as well) · Job Description: · The Device Engineer II will be responsible for providing design, development and implementation support to project teams developing combination drug delivery devices for parenter ...
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associate director, chemical development/drug substance manufacturing
Found in: Careerbuilder One Red US C2 - 19 hours ago
Cytokinetics, Incorporated South San Francisco, CA , USA, United StatesCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle p ...
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senior director, peptide therapeutics
Found in: Careerbuilder One Red US C2 - 18 hours ago
Genentech South San Francisco, CA , USA, United StatesThe Position · Senior Director, Peptide Therapeutics · Who We Are · The Department of Peptide Therapeutics oversees two technology platforms, disulfide-constrained peptides (DCPs) and macrocyclic peptides (MCPs), which are key drug-discovery modalities for gRED's research pipelin ...
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Associate Director, Chemical Development
Found in: Lensa US 4 C2 - 4 days ago
Enigma Search South San Francisco, United StatesThe Associate Director of CMC, reporting to the Sr. VP of Chemistry, is primarily responsible for the development and manufacture of small-molecule drug substances in support of clinical development of the company's pipeline compounds. The candidate will provide technical and org ...
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Associate Director, Chemical Development
Found in: Lensa US 4 C2 - 14 hours ago
Enigma Search South San Francisco, United StatesThe Associate Director of CMC, reporting to the Sr. VP of Chemistry, is primarily responsible for the development and manufacture of small-molecule drug substances in support of clinical development of the companys pipeline compounds. The candidate will provide technical and orga ...
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Associate Director, Chemical Development/Drug Substance Manufacturing
Found in: Lensa US 4 C2 - 6 days ago
Cytokinetics South San Francisco, United StatesCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle p ...
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Associate Director, Chemical Development
Found in: Lensa US 4 C2 - 5 days ago
Enigma Search South San Francisco, United StatesThe Associate Director of CMC, reporting to the Sr. VP of Chemistry, is primarily responsible for the development and manufacture of small-molecule drug substances in support of clinical development of the companys pipeline compounds. The candidate will provide technical and orga ...
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Associate Director, Chemical Development/Drug Substance Manufacturing
Found in: Lensa US 4 C2 - 14 hours ago
Cytokinetics, Incorporated South San Francisco, United StatesCytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or ...
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Head/Director of Chemistry
Found in: Appcast Linkedin GBL C2 - 2 hours ago
Life Science People South San Francisco, United StatesLife Science People has partnered with a groundbreaking client currently moving through stealth mode. Leveraging a significant Series A, this venture is spearheading a committed to transforming high-confidence, genetically validated targets into tangible therapeutic solutions. Wi ...
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Medical Device Engineer
Found in: Appcast Linkedin GBL C2 - 6 hours ago
MindSource South San Francisco, United States:The Device Engineer II will be responsible for providing design, development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics. · The candidate has technical expertise in the development and commer ...
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Associate Director, Clinical Supply Chain
Found in: Lensa US 4 C2 - 2 days ago
DSJ Global South San Francisco, United StatesAbout: · We are currently looking for an Associate Director of Supply Chain to oversee the supply chain operations for our innovative clinical programs. This role entails establishing and managing supply and demand planning processes, coordinating clinical orders, and ensuring ...
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Device Engineer II
Found in: Appcast Linkedin GBL C2 - 6 hours ago
TalentBurst, an Inc 5000 company South San Francisco, United StatesIndustry: Pharma Devices · Position: Device Engineer II · Location: South San Francisco, CA (High Possibility of hybrid schedule) · Duration: 12 months contract (+Possibility of extension) · Executive Summary · The Device Engineer II will be responsible for providing design, deve ...
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Senior Device Engineer
Found in: Appcast Linkedin GBL C2 - 6 hours ago
TalentBurst, an Inc 5000 company South San Francisco, United StatesTitle: Device Engineer II, Req#: ROCGJP · Location: South San Francisco, CA (100% onsite) · Duration: 12 months Contract · Job Description: · The Device Engineer II will be responsible for providing design, development, and implementation support to project teams developing comb ...
Associate Director, Formulation and Drug Delivery - South San Francisco, United States - Astrix
Description
Our client is a clinical stage biopharmaceutical company dedicated to improving patients' lives. They develop multiple precision medicines targeting hallmark cancer resistance mechanisms.
Title: Associate Director, Formulation and Drug Delivery
Location: South San Francisco, California
Salary: $175k - 215k
Position Summary:
We are seeking an experienced and highly motivated small molecule formulation scientist with a proven record of sustained laboratory achievement and innovation to join our growing Department of Pharmaceutical Sciences (PharmSci/CMC). The successful candidate will report to the Director of Formulation and Drug Delivery and will be responsible for:
Requirements
