Director / Senior Director, Late-stage Process and Analytical Development
2 weeks ago
Responsibilities:
- Strategic Leadership: Provide strategic direction and leadership in late-stage process development activities, collaborating closely with cross-functional teams to align efforts with corporate goals and regulatory requirements.
- Process Optimization: Lead efforts to optimize late-stage manufacturing processes for drug substances and drug products, focusing on scalability, robustness, and efficiency to meet clinical and commercial demands.
- Technology Transfer: Oversee the successful transfer of late-stage processes to manufacturing sites, ensuring seamless integration and alignment with quality standards and regulatory expectations.
- Risk Management: Identify and mitigate potential risks associated with late-stage process development, implementing strategies to enhance process reliability and product quality while maintaining compliance with regulatory guidelines.
- Continuous Improvement: Drive continuous improvement initiatives within the late-stage process development function, leveraging data-driven insights and best practices to enhance efficiency, quality, and innovation.
- Analytical Method Development: Oversee and drive the design, optimization, and validation of analytical methods, employing state-of-the-art techniques to enable accurate and reliable assessment of product attributes.
- Analytical Testing: Coordinate analytical testing activities, including sample analysis, data interpretation, and troubleshooting to support process development, manufacturing, and regulatory submissions.
- Analytical Compliance: Ensure analytical methods comply with regulatory standards and industry best practices, maintaining alignment with current Good Manufacturing Practices (cGMP) and International Council for Harmonisation (ICH) guidelines.
- Innovation: Explore innovative approaches and technologies to enhance analytical capabilities, fostering continuous improvement and staying at the forefront of analytical sciences.
- Method Transfer: Facilitate the transfer of analytical methods to internal and external testing laboratories, ensuring method robustness, reproducibility, and accuracy.
- Collaboration: Foster strong collaborations with internal stakeholders, including Research, Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs, and Clinical Development teams, to facilitate cross-functional alignment and decision-making.
- Regulatory Compliance: Ensure adherence to regulatory requirements and industry standards throughout the late-stage process and analytical method development lifecycle, supporting the preparation and review of regulatory submissions as needed.
- Talent Development: Mentor and develop team members, providing guidance, support, and opportunities for growth to cultivate a high-performing and engaged workforce.
- Stay Current: Keep abreast of emerging trends, technologies, and regulatory requirements in process and analytical sciences, leveraging insights to drive continuous improvement and innovation.
- PhD or Master's degree in Chemical Engineering, Pharmaceutical Sciences, or related field with a minimum of 10 years of experience in late-stage process development within the biopharmaceutical industry.
- Proven track record of success in leading late-stage process development programs for biologic or cell-based therapies, from process optimization through technology transfer and commercialization.
- Deep understanding of cGMP regulations, quality systems, and regulatory requirements relevant to late-stage process development and manufacturing.
- Strong project management skills, with the ability to prioritize and manage multiple projects simultaneously in a fast-paced environment.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external partners.
- Strategic mindset with a focus on driving results, innovation, and continuous improvement to achieve organizational objectives.
- Leadership experience, with demonstrated ability to mentor, motivate, and develop a high-performing team.
Powered by JazzHR
4ngbOWoYwE
-
San Francisco, United States IDEAYA Biosciences, Inc. Full timeWe are seeking an experienced and highly motivated Director/Senior Director, Drug Product/Formulation Development who will report to the VP of CMC. This individual will drive the drug product development and strategy including pre-formulation, formulation, scale-up and manufacture for all our preclinical and clinical projects. The scope spans the development...
-
Associate Director, CMC Analytical Development
2 weeks 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...
-
San Diego, United States Kumquat Biosciences Full timeDescription: Location: San Diego, CA 92121 Position type: Full time Job Code: KB-CMC-XX Required education: Ph.D. Degree (preferred) /Master's Degree Area(s) of expertise desired: Analytical chemistry or related field Description Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments....
-
San Diego, United States Shelby American Inc Full timeDescription Location: San Diego, CA 92121 Position type: Full time Job Code: KB-CMC-XX Required education: Ph.D. Degree (preferred) /Master’s Degree Area(s) of expertise desired: Analytical chemistry or related field Description Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat...
-
South San Francisco, United States IDEAYA Biosciences Full timeWe are seeking an experienced and highly motivated Director/Senior Director, Drug Product/Formulation Development who will report to the VP of CMC. This individual will drive the drug product development and strategy including pre-formulation, formulation, scale-up and manufacture for all our preclinical and clinical projects. The scope spans the development...
-
South San Francisco, California, United States IDEAYA Biosciences Full timeWe are seeking an experienced and highly motivated Director/Senior Director, Drug Product/Formulation Development who will report to the VP of CMC. This individual will drive the drug product development and strategy including pre-formulation, formulation, scale-up and manufacture for all our preclinical and clinical projects. The scope spans the development...
-
South San Francisco, United States BioSpace Full timeJob DetailsWe are seeking an experienced and highly motivated Director/Senior Director, Drug Product/Formulation Development who will report to the VP of CMC. This individual will drive the drug product development and strategy including pre-formulation, formulation, scale-up and manufacture for all our preclinical and clinical projects. The scope spans the...
-
Associate Director, CMC Analytical Development
2 weeks 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...
-
Associate Director, CMC Analytical Development
1 month 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...
-
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...
-
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...
-
Associate Director, CMC Analytical Development
2 weeks ago
South San Francisco, United States BioSpace Full timeJob DetailsAlumis 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...
-
Associate Director, CMC Analytical Development
3 weeks 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...
-
Senior Director, DMPK
1 month ago
San Diego, California, United States Vertex Pharmaceuticals, Inc Full timeVertex San Diego Drug Metabolism and Pharmacokinetics (DMPK) team is seeking a highly motivated, experienced scientist and leader Senior Director level to help advance discovery and development of transformational therapies for serious unmet medical needs.The Senior Director of Drug Metabolism & Pharmacokinetics will be part of the global DMPK and local site...
-
Medical Director/ Senior Medical Director
7 days ago
San Diego, United States SciPro Inc. Full timeMedical Director/Senior Director of Clinical Development - San Diego I am currently searching for a Medical Director/Senior Director of Clinical Development for an exciting San Diego based Orphan Disease organization who are currently developing a product which will be first in class and is often described as ground breaking. The Medical Director/Senior...
-
Medical Director/ Senior Medical Director
1 week ago
San Diego, United States SciPro Full timeMedical Director/Senior Director of Clinical Development - San Diego I am currently searching for a Medical Director/Senior Director of Clinical Development for an exciting San Diego based Orphan Disease organization who are currently developing a product which will be first in class and is often described as ground breaking.The Medical Director/Senior...
-
Medical Director/ Senior Medical Director
1 week ago
San Diego, United States SciPro Full timeMedical Director/Senior Director of Clinical Development - San Diego I am currently searching for a Medical Director/Senior Director of Clinical Development for an exciting San Diego based Orphan Disease organization who are currently developing a product which will be first in class and is often described as ground breaking.The Medical Director/Senior...
-
Medical Director/ Senior Medical Director
2 days ago
San Diego, United States SciPro Full timeMedical Director/Senior Director of Clinical Development - San Diego I am currently searching for a Medical Director/Senior Director of Clinical Development for an exciting San Diego based Orphan Disease organization who are currently developing a product which will be first in class and is often described as ground breaking.The Medical Director/Senior...
-
San Diego, United States Discovery Senior Living Full timeJob DescriptionJob DescriptionAbout Discovery Senior LivingDiscovery Senior Living ranks prominently among the 5 largestsenior housing providers in the US, and is nationally renowned for designing,developing, marketing, and operating a multi-brand portfolio of upscale, luxurysenior-living communities. With over 250 communities in nearly 40states, and 15,000...
-
San Diego, United States Discovery Senior Living Full timeAbout Discovery Senior Living Discovery Senior Living ranks prominently among the 5 largestsenior housing providers in the US, and is nationally renowned for designing,developing, marketing, and operating a multi-brand portfolio of upscale, luxurysenior-living communities. With over 250 communities in nearly 40states, and 15,000 dedicated employees,...
