(Sr)Director, Analytical Development & Stability ESSENTIAL JOB FUNCTIONS: * Responsible for all ... Author and review CMC sections for all regulatory filings (INDs, IMPDs, NDAs, MAAs). * Provide ...
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(Sr)Director, Analytical Development & Stability ESSENTIAL JOB FUNCTIONS: * Responsible for all ... Author and review CMC sections for all regulatory filings (INDs, IMPDs, NDAs, MAAs). * Provide ...
New
Scientist, Biologics CMC Analytical Development
Foster City, CA · On-site
$146K - $189K/yr
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled ... Scientist, Biologics CMC Analytical Development Gilead Sciences (Foster City, CA) is seeking a ...
Scientist, Biologics CMC Analytical Development
Foster City, CA · On-site
$146K - $189K/yr
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled ... Scientist, Biologics CMC Analytical Development Gilead Sciences (Foster City, CA) is seeking a ...
You bring strong technical expertise in analytical method development, troubleshooting, transfer ... Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for ...
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You bring strong technical expertise in analytical method development, troubleshooting, transfer ... Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for ...
New
Scientific Director, Pharmaceutical Development Analytics
San Diego, CA · On-site
$150 - $200/hr
... Analytical Development, Quality, Regulatory CMC, and Commercial Manufacturing & Supply Chain to ... all stages of development * Demonstrated expertise in Design of Experiments (DoE), multivariate ...
Scientific Director, Pharmaceutical Development Analytics
San Diego, CA · On-site
$150 - $200/hr
... Analytical Development, Quality, Regulatory CMC, and Commercial Manufacturing & Supply Chain to ... all stages of development * Demonstrated expertise in Design of Experiments (DoE), multivariate ...
You bring strong technical expertise in analytical method development, troubleshooting, transfer, and validation, along with a solid understanding of phase-appropriate CMC, GMP, and regulatory ...
New
You bring strong technical expertise in analytical method development, troubleshooting, transfer, and validation, along with a solid understanding of phase-appropriate CMC, GMP, and regulatory ...
New
... Analytical Development, Quality, Regulatory CMC, and Commercial Manufacturing & Supply Chain to ... all stages of development * Demonstrated expertise in:Design of Experiments (DoE), multivariate ...
... Analytical Development, Quality, Regulatory CMC, and Commercial Manufacturing & Supply Chain to ... all stages of development * Demonstrated expertise in:Design of Experiments (DoE), multivariate ...
Scientist, Biologics CMC Analytical Development
Foster City, CA · On-site
$146K - $189K/yr
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled ... Scientist, Biologics CMC Analytical Development Gilead Sciences (Foster City, CA) isseekinga ...
Scientist, Biologics CMC Analytical Development
Foster City, CA · On-site
$146K - $189K/yr
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled ... Scientist, Biologics CMC Analytical Development Gilead Sciences (Foster City, CA) isseekinga ...
... CMC analytical strategy. * Lead and oversee analytical development execution across internal and external teams to support the development, characterization, and manufacturing of API and drug product ...
... CMC analytical strategy. * Lead and oversee analytical development execution across internal and external teams to support the development, characterization, and manufacturing of API and drug product ...
This role provides phase-appropriate analytical development, validation, and analytical CMC regulatory support to ensure successful advancement of development candidates through clinical and ...
This role provides phase-appropriate analytical development, validation, and analytical CMC regulatory support to ensure successful advancement of development candidates through clinical and ...
This role provides phase-appropriate analytical development, validation, and analytical CMC ... All qualified applicants will receive consideration for employment without regard to race, color ...
This role provides phase-appropriate analytical development, validation, and analytical CMC ... All qualified applicants will receive consideration for employment without regard to race, color ...
This role provides phase-appropriate analytical development, validation, and analytical CMC regulatory support to ensure successful advancement of development candidates through clinical and ...
This role provides phase-appropriate analytical development, validation, and analytical CMC regulatory support to ensure successful advancement of development candidates through clinical and ...
Deep understanding of CMC strategies and analytical enablement for small molecule development ... All legitimate communication from Revolution Medicines will come from an official @revmed.com email ...
Deep understanding of CMC strategies and analytical enablement for small molecule development ... All legitimate communication from Revolution Medicines will come from an official @revmed.com email ...
Senior Scientist I Analytical Development
South San Francisco, CA · On-site
$112K - $135K/yr
The small molecule CMC team is seeking highly motivated Sr. Scientist I of Analytical Development to help build our dynamic small molecule CMC group at Alumis. The successful candidate will help to ...
Senior Scientist I Analytical Development
South San Francisco, CA · On-site
$112K - $135K/yr
The small molecule CMC team is seeking highly motivated Sr. Scientist I of Analytical Development to help build our dynamic small molecule CMC group at Alumis. The successful candidate will help to ...
Director, Analytical Development
Aliso Viejo, CA · On-site
$225K - $250K/yr
... and CMC strategy to support NDA submission, future commercial manufacturing, and lifecycle ... all stages of the development lifecycle through commercialization. * Oversee the design and ...
Director, Analytical Development
Aliso Viejo, CA · On-site
$225K - $250K/yr
... and CMC strategy to support NDA submission, future commercial manufacturing, and lifecycle ... all stages of the development lifecycle through commercialization. * Oversee the design and ...
Senior Scientist I Analytical Development
South San Francisco, CA · On-site
$112K - $135K/yr
The small molecule CMC team is seeking highly motivated Sr. Scientist I of Analytical Development ... Alumis compensation packages include generous stock option grants for all employees as well as an ...
Senior Scientist I Analytical Development
South San Francisco, CA · On-site
$112K - $135K/yr
The small molecule CMC team is seeking highly motivated Sr. Scientist I of Analytical Development ... Alumis compensation packages include generous stock option grants for all employees as well as an ...
... and CMC strategy to support NDA submission, future commercial manufacturing, and lifecycle ... all stages of the development lifecycle through commercialization. * Oversee the design and ...
Quick apply
... and CMC strategy to support NDA submission, future commercial manufacturing, and lifecycle ... all stages of the development lifecycle through commercialization. * Oversee the design and ...
Senior Scientist I Analytical Development
$112K - $135K/yr
The small molecule CMC team is seeking highly motivated Sr. Scientist I of Analytical Development ... Alumis compensation packages include generous stock option grants for all employees as well as an ...
Quick apply
Senior Scientist I Analytical Development
$112K - $135K/yr
The small molecule CMC team is seeking highly motivated Sr. Scientist I of Analytical Development ... Alumis compensation packages include generous stock option grants for all employees as well as an ...
Develop and implement analytical strategies appropriate for each stage of CMC development and ... TO ALL RECRUITMENT AGENCIES: Xaira Therapeutics does not accept agency resumes. Please do not ...
Develop and implement analytical strategies appropriate for each stage of CMC development and ... TO ALL RECRUITMENT AGENCIES: Xaira Therapeutics does not accept agency resumes. Please do not ...
Representing CMC (DS, DP, Analytical) in applicable governance forums serving as spokesperson and ... Effective verbal communication at all levels throughout the organization. * Strong working ...
Representing CMC (DS, DP, Analytical) in applicable governance forums serving as spokesperson and ... Effective verbal communication at all levels throughout the organization. * Strong working ...
Representing CMC (DS, DP, Analytical) in applicable governance forums serving as spokesperson and ... Effective verbal communication at all levels throughout the organization. * Strong working ...
Representing CMC (DS, DP, Analytical) in applicable governance forums serving as spokesperson and ... Effective verbal communication at all levels throughout the organization. * Strong working ...
All Analytical Development Cmc information
What is the difference between All Analytical Development Cmc vs Analytical Scientist?
| Aspect | All Analytical Development Cmc | Analytical Scientist |
|---|---|---|
| Credentials | Bachelor's or Master's in Chemistry, Pharmaceutical Sciences, or related fields; relevant certifications | Bachelor's or Master's in Chemistry, Pharmaceutical Sciences, or related fields; relevant certifications |
| Work Environment | Pharmaceutical or biotech R&D labs, manufacturing support | Research labs, quality control, or manufacturing settings |
| Industry Usage | Used in CMC (Chemistry, Manufacturing, and Controls) documentation and development | Commonly used in analytical testing, method development, and validation |
All Analytical Development Cmc professionals focus on developing and validating analytical methods specifically for CMC documentation and regulatory submissions. Analytical Scientists often work on analytical testing and method development across various stages of product development. While both roles require similar educational backgrounds and work environments, All Analytical Development Cmc roles are more specialized in CMC processes, whereas Analytical Scientists may have broader analytical responsibilities.
What are popular job titles related to All Analytical Development Cmc jobs in California? For All Analytical Development Cmc jobs in California, the most frequently searched job titles are:
What job categories do people searching All Analytical Development Cmc jobs in California look for? The top searched job categories for All Analytical Development Cmc jobs in California are:
What cities in California are hiring for All Analytical Development Cmc jobs? Cities in California with the most All Analytical Development Cmc job openings:
(Sr)Director, Analytical Development & Stability (San Diego)
San Diego, CA • On-site
Full-time
Posted yesterday
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Job description
(Sr)Director, Analytical Development & Stability ESSENTIAL JOB FUNCTIONS:
#J-18808-Ljbffr- Responsible for all management aspects of Analytical R&D and Stability from lead optimization into clinical development through validation for commercialization.
- Will serve as the subject matter expert and lead the analytical research and development/stability study/QC functions with internal and external CRO/CDMOs.
- Provided direction, leadership, and oversight for all analytical methods development and validation, stability and quality control elements at contract research laboratories and manufacturing organizations.
- Guide external third parties to perform analytical activities in support of technology transfer, process development, optimization, qualification, and validation related to Drug Substance and Drug Product manufacturing operations.
- Provide oversight for the transfer of preclinical analytical methods from Research through all clinical phases of development and into QC at commercial manufacturing sites.
- Author and review CMC sections for all regulatory filings (INDs, IMPDs, NDAs, MAAs).
- Provide strategic support and technical documentation for answering regulatory questions during submission reviews and throughout clinical development.
- Responsible for Analytical Development and Stability budget recommendations and management of associated expenses.
- Provide direction and leadership for Analytical Research & Development and Stability staff.
- BS with 15 + yrs., MS with 12+ yrs., or Ph.D. with 10+ yrs. in analytical sciences or related field.
- 8+ years of relevant industry experience in analytical development and stability.
- Demonstrated experience in QC/QA regulations.
- Familiar with cGMP compliance and ICH guidelines.
- Experience and management of outsourced projects with contractors.
- Strong leadership, teamwork, and collaboration skills.
- Ability to thrive in a highly entrepreneurial, fast paced, and capital efficient environment.
- Strong written and communication skills; and an ability to work effectively with a diverse team of co-workers in a dynamic environment.