We have other current jobs related to this field that you can find below
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San Diego, United States Kumquat Biosciences Inc Full timeJob DescriptionJob DescriptionDescription:Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founder to translate innovative research to novel therapeutics. Our team has a proven track record of drug...
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San Diego, United States Kumquat Biosciences Inc Full timeJob DescriptionJob DescriptionDescription:Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founder to translate innovative research to novel therapeutics. Our team has a proven track record of drug...
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Associate Director, CMC Analytical Development
3 months ago
South San Francisco, United States Alumis Inc. Full timeAlumis is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. The small molecule CMC team is seeking a highly...
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Associate Director, CMC Analytical Development
2 months ago
South San Francisco, California, United States Alumis Inc. Full timeAlumis is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.The small molecule CMC team is seeking a highly...
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Associate Director, CMC Analytical Development
3 months ago
South San Francisco, United States Alumis Full timeJob DescriptionJob DescriptionSalary: Alumis is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.The small...
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Associate Director, CMC Analytical Development
3 months ago
South San Francisco, United States Alumis Full timeJob DescriptionJob DescriptionSalary: Alumis is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.The small...
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San Diego, United States Kumquat Biosciences Inc Full timeJob DescriptionJob DescriptionDescription:Location: San Diego, CA 92121Position type: Full timeJob Code: KB-CMC-XXRequired education: Ph.D. Degree (preferred) /Master’s DegreeArea(s) of expertise desired: Analytical chemistry or related fieldDescriptionKumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer...
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San Diego, United States Kumquat Biosciences Inc Full timeJob DescriptionJob DescriptionDescription:Location: San Diego, CA 92121Position type: Full timeJob Code: KB-CMC-XXRequired education: Ph.D. Degree (preferred) /Master’s DegreeArea(s) of expertise desired: Analytical chemistry or related fieldDescriptionKumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer...
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Director/Senior Director, CMC Analytical
2 months ago
South San Francisco, California, United States Annexon, Inc. Full timeWork LocationCorporate Headquarters (South San Francisco, CA) Onsite – HybridPosition SummaryThe Director/Senior Director – CMC Analytical incumbent is responsible for working closely with the SVP, CMC Research in leading and maintaining QA Manufacturing Operations. The Director/Senior Director – CMC Analytical will Lead preclinical to clinical...
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San Diego, United States Kumquat Biosciences Inc Full timeJob DescriptionJob DescriptionDescription:Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founders to translate innovative research to novel therapeutics. Our team has a proven track record of drug...
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Director of Regulatory Affairs CMC
1 month ago
San Francisco, United States SciPro Full timeDirector Regulatory Affairs CMCSan Francisco, CA (Hybrid)6 month initial contract (likely extension and conversion to FTE)This client is a clinical-stage precision oncology biotech focused on creating cutting-edge therapies to target cancer treatments. Responsibilities:Develop and implement CMC regulatory strategies to facilitate the clinical development and...
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San Francisco, California, United States Nurix Therapeutics Full timeCompanyNurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix's extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries,...
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Associate Director, Quality Assurance
5 days ago
San Diego, United States Janux Therapeutics Full timeJOB SUMMARY The Associate Director of QA, in conjunction with the Director, QA, will be responsible for the performance of the Quality Management System including training, compliance, audit planning and management, process improvement, and effective communications related to quality initiatives with the leadership team. The person who joins our team in this...
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Business Development Manager
6 days ago
San Diego, United States Vets Hired Full timeAbout the job Business Development Manager / Director Roles and Responsibilities Identify, research, and develop future business development opportunities Arrange business meetings with prospective clients; Promote the company's services addressing or predicting clients'objectives Develop new proposals and secure new business with technical team support...
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Business Development Manager
2 weeks ago
San Diego, United States Pharmaron Full time $150,000 - $200,000Job DescriptionJob DescriptionCome Join Our Growing Team!We are seeking a Business Development Manager/Director DP&C (Discovery, Pre-Clinical & CMC). Location: The candidate must be located in the San Diego area. The Business Development Manager/Director will generate and maintain profitable business relations with partners, promote Pharmaron as the CRO of...
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South San Francisco, United States Abdera Therapeutics Full timeJob DescriptionJob DescriptionWho we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively...
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South San Francisco, United States Abdera Therapeutics Full timeJob DescriptionJob DescriptionWho we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively...
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Associate Director, Business Development
3 months ago
San Diego, United States TANVEX BIOPHARMA USA INC Full timeJob DescriptionJob DescriptionDescription:SUMMARY The Associate Director, Business Development will assist in identifying prospective partners and develop outbound sales tactics to engage them. Manages key client relationships and works to build new ones.JOB RESPONSIBILITIES· The role of the Associate Director is to drive sales in a given territory to...
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Construction Laborer
4 weeks ago
San Antonio, United States CMC Development & Construction Full timeJob DescriptionJob DescriptionSalary: At CMC Development & Construction, working together on Developing Tomorrow is our motto. Founded in 2016, CMC is a full-service General Contractor firm which provides services such as construction management, design-build, and project management and manages projects with industry-leading innovation. Ranked in the Top 25...
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Construction Laborer
3 months ago
San Antonio, United States CMC Development & Construction Full timeJob DescriptionJob DescriptionSalary: At CMC Development & Construction, working together on Developing Tomorrow is our motto. Founded in 2016, CMC is a full-service General Contractor firm which provides services such as construction management, design-build, and project management and manages projects with industry-leading innovation. Ranked in the Top 25...
Associate Director/ Director, CMC Formulation Development
2 months ago
Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founder to translate innovative research to novel therapeutics. Our team has a proven track record of drug discovery and development, having played pivotal roles in the discovery of multiple clinical-stage compounds as well as an approved drug for the treatment of cancers and immune-mediated inflammatory diseases.
We are currently seeking a highly motivated, creative CMC formulation professional at associate director or director level to join our CMC team in San Diego. This candidate will report to the Senior Director and Head of CMC. This candidate is expected to work closely with Kumquat internal discovery and development teams as well as external CRO/CDMO companies to drive programs into early and late clinical development. This is a position with responsibility for formulation strategy design, process development and manufacturing. The ideal candidate will have an in-depth understanding in all aspects of oral solid dosage formulations and injectable formulations. A strong team player who is detail-oriented and has the desire to learn and understand life-cycle product management concepts and practice is essential. The candidate will have the opportunity to work on multiple programs within the company’s pipeline which comprises potentially first-in-class approaches & novel-novel targets.
Role responsibilities
- Understand the development candidate’s physicochemical properties and target product profile to evaluate formulation options and design phase appropriate formulations at different development stages.
- Select external CRO/CDMO partners based on project needs and the external parties’ technical capabilities, quality system, and track records.
- Prepare RFPs and evaluate proposals based on the targeted product quality, project timeline, and budget.
- Plan and oversee drug product process optimization, GMP manufacturing, packaging, labeling, stability testing activities.
- Track process development/validation history and manage CMC drug product related documents in support of life cycle of quality improvement and regulatory filing/updates.
- Work closely with a cross-functional team within and outside of the CMC department to align with key stakeholders (CMC, Clinical, Quality Assurance and Regulatory).
- Author and review CMC drug product related sections for regulatory filing and annual updates.
- Stay current on industry trends and regulatory requirements to ensure delivery of quality products under cGMP environment.
- Prepare and communicate research results in both oral and written format.
- Contribute to a fast-paced, dynamic, data-driven scientific culture that embraces innovation and excellence.
- Ph.D. or M.S. in chemistry, chemical engineering, pharmaceutical science, or related discipline with at least 10 years of industry experience (title for this position will be commensurate with the candidate’s experience and qualifications).
- Highly familiar with current formulation principles and industry practices.
- Extensive process development/ optimization, scale-up and process validation expertise, with emphasis on solid oral dosage forms.
- Experience with injectable formulations and modern enabling technologies is a plus.
- Track record of accomplishment in managing CMC drug product projects at early and late development stages.
- Ability to enable external CRO/CDMO to achieve project goals on time and under budget.
- Strong written and communication skills, good problem-solving abilities, and an ability to work effectively with a diverse team of co-workers in a dynamic environment.
Kumquat Biosciences offers an attractive salary and benefits package, including equity incentives.
