Associate Director QC will be responsible for oversight of the Quality Control testing at contract labs for drug substance, drug product, and stability programs across commercial and development ...
Associate Director QC will be responsible for oversight of the Quality Control testing at contract labs for drug substance, drug product, and stability programs across commercial and development ...
Manager, Analytical Development
Redwood City, CA · On-site
$160K - $189K/yr
This position, reporting to the Sr. Director of Analytical Development and Quality Control, will be responsible for supporting analytical development activities for pharmaceutical drug substances and ...
Manager, Analytical Development
Redwood City, CA · On-site
$160K - $189K/yr
This position, reporting to the Sr. Director of Analytical Development and Quality Control, will be responsible for supporting analytical development activities for pharmaceutical drug substances and ...
Manager, Analytical Development
Redwood City, CA · On-site
$160K - $189K/yr
This position, reporting to the Sr. Director of Analytical Development and Quality Control, will be responsible for supporting analytical development activities for pharmaceutical drug substances and ...
Manager, Analytical Development
Redwood City, CA · On-site
$160K - $189K/yr
This position, reporting to the Sr. Director of Analytical Development and Quality Control, will be responsible for supporting analytical development activities for pharmaceutical drug substances and ...
Scientist, Analytical Development
San Diego, CA · On-site
$110K - $135K/yr
This role is on-site in San Diego, CA and reports to the Director of Analytical Development. Responsibilities * Independently design, plan and conduct multicolor flow cytometry-based laboratory ...
Scientist, Analytical Development
San Diego, CA · On-site
$110K - $135K/yr
This role is on-site in San Diego, CA and reports to the Director of Analytical Development. Responsibilities * Independently design, plan and conduct multicolor flow cytometry-based laboratory ...
Scientist, Analytical Development
San Diego, CA · On-site
$110K - $135K/yr
This role is on-site in San Diego, CA and reports to the Director of Analytical Development. Responsibilities * Independently design, plan and conduct multicolor flow cytometry-based laboratory ...
Quick apply
Scientist, Analytical Development
San Diego, CA · On-site
$110K - $135K/yr
This role is on-site in San Diego, CA and reports to the Director of Analytical Development. Responsibilities * Independently design, plan and conduct multicolor flow cytometry-based laboratory ...
Scientist, Analytical Development
San Diego, CA · On-site
$110K - $135K/yr
This role is on-site in San Diego, CA and reports to the Director of Analytical Development. Responsibilities * Independently design, plan and conduct multicolor flow cytometry-based laboratory ...
Scientist, Analytical Development
San Diego, CA · On-site
$110K - $135K/yr
This role is on-site in San Diego, CA and reports to the Director of Analytical Development. Responsibilities * Independently design, plan and conduct multicolor flow cytometry-based laboratory ...
Analytical Development Scientist
Tustin, CA · On-site
$110K - $137K/yr
Direct impact on the development and manufacturing of life-saving therapies. What's a typical day as Analytical Development Scientist? You'll be: * Design and optimize analytical experiments ...
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Analytical Development Scientist
Tustin, CA · On-site
$110K - $137K/yr
Direct impact on the development and manufacturing of life-saving therapies. What's a typical day as Analytical Development Scientist? You'll be: * Design and optimize analytical experiments ...
The Scientist I, Analytical Development, is responsible for executing analytical testing and ... Communicate experimental progress and data interpretation to direct team members and project leads ...
The Scientist I, Analytical Development, is responsible for executing analytical testing and ... Communicate experimental progress and data interpretation to direct team members and project leads ...
Associate Director / Director, Analytical Characterizations
South San Francisco, CA · On-site
$154K - $300K/yr
Manage CROs and external collaborations for method development, validation, tech transfer, and analytical support ensuring quality, timelines, and cost efficiency. * Evaluate emerging analytical ...
Associate Director / Director, Analytical Characterizations
South San Francisco, CA · On-site
$154K - $300K/yr
Manage CROs and external collaborations for method development, validation, tech transfer, and analytical support ensuring quality, timelines, and cost efficiency. * Evaluate emerging analytical ...
The Scientist I, Analytical Development, is responsible for executing analytical testing and ... Communicate experimental progress and data interpretation to direct team members and project leads ...
The Scientist I, Analytical Development, is responsible for executing analytical testing and ... Communicate experimental progress and data interpretation to direct team members and project leads ...
Manage CROs and external collaborations for method development, validation, tech transfer, and analytical support ensuring quality, timelines, and cost efficiency. * Evaluate emerging analytical ...
Manage CROs and external collaborations for method development, validation, tech transfer, and analytical support ensuring quality, timelines, and cost efficiency. * Evaluate emerging analytical ...
Senior Scientist, Analytical Development & Quality Control About Us Protagonist Therapeutics is a ... This position reports to the Senior Director of ADQC. We are committed to a thriving in-office ...
Senior Scientist, Analytical Development & Quality Control About Us Protagonist Therapeutics is a ... This position reports to the Senior Director of ADQC. We are committed to a thriving in-office ...
Senior Scientist, Analytical Development amp; Quality Control About Us Protagonist Therapeutics is ... This position reports to the Senior Director of ADQC. We are committed to a thriving in-office ...
Senior Scientist, Analytical Development amp; Quality Control About Us Protagonist Therapeutics is ... This position reports to the Senior Director of ADQC. We are committed to a thriving in-office ...
Every member of Gilead's team plays a critical role in the discovery and development of life ... Manage direct reports responsible for Analytical Quality Assurance. Knowledge, Experience and ...
Every member of Gilead's team plays a critical role in the discovery and development of life ... Manage direct reports responsible for Analytical Quality Assurance. Knowledge, Experience and ...
The Director partners cross-functionally with Pharmaceutical & Analytical Development, Quality, Regulatory CMC, and Commercial Manufacturing & Supply Chain to ensure that development and ...
The Director partners cross-functionally with Pharmaceutical & Analytical Development, Quality, Regulatory CMC, and Commercial Manufacturing & Supply Chain to ensure that development and ...
Every member of Gilead's team plays a critical role in the discovery and development of life ... Manage direct reports responsible for Analytical Quality Assurance. Knowledge, Experience and ...
Every member of Gilead's team plays a critical role in the discovery and development of life ... Manage direct reports responsible for Analytical Quality Assurance. Knowledge, Experience and ...
Every member of Gilead's team plays a critical role in the discovery and development of life ... Manage direct reports responsible for Analytical Quality Assurance. Knowledge, Experience and ...
Every member of Gilead's team plays a critical role in the discovery and development of life ... Manage direct reports responsible for Analytical Quality Assurance. Knowledge, Experience and ...
Associate Director, Technical Operations (Analytical Development-Biologics)
San Diego, CA · On-site +1
... analytical development of biologics, preferably in late-stage drug development. * Direct knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS and other relevant analytical ...
Associate Director, Technical Operations (Analytical Development-Biologics)
San Diego, CA · On-site +1
... analytical development of biologics, preferably in late-stage drug development. * Direct knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS and other relevant analytical ...
... analytical development of biologics, preferably in late-stage drug development. * Direct knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS and other relevant analytical ...
... analytical development of biologics, preferably in late-stage drug development. * Direct knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS and other relevant analytical ...
Senior Scientist, Analytical Development, Manager
San Diego, CA · On-site
$97K - $132K/yr
Senior Scientist, Analytical Development, Manager About Site Catalent's San Diego, CA site is an ... This position offers the chance to make a direct impact on patient outcomes by improving the ...
Senior Scientist, Analytical Development, Manager
San Diego, CA · On-site
$97K - $132K/yr
Senior Scientist, Analytical Development, Manager About Site Catalent's San Diego, CA site is an ... This position offers the chance to make a direct impact on patient outcomes by improving the ...
Director Analytical Development information
See California salary details
$100.2K is the 25th percentile. Wages below this are outliers.
$87.8K - $105.6K
36% of jobs
$105.6K - $123.5K
0% of jobs
$123.5K - $141.3K
0% of jobs
$141.3K - $159.1K
0% of jobs
$159.1K - $176.9K
0% of jobs
$176.9K - $194.7K
4% of jobs
$194.7K - $212.5K
8% of jobs
The median wage is $214.2K / yr.
$212.5K - $230.3K
16% of jobs
$241.2K is the 75th percentile. Wages above this are outliers.
$230.3K - $248.1K
16% of jobs
$248.1K - $265.9K
11% of jobs
$265.9K - $283.7K
7% of jobs
$87.8K
$188.9K
$283.7K
How much do director analytical development jobs pay per year?
What is a director analytical development?
A Director of Analytical Development oversees the strategy, development, and implementation of analytical methods to support product development and manufacturing. They lead a team of scientists, ensure regulatory compliance, and collaborate with cross-functional teams to optimize processes. Their role includes troubleshooting analytical issues, validating methods, and contributing to regulatory submissions. This position is critical in maintaining product quality and ensuring data-driven decision-making in pharmaceutical, biotechnology, or related industries.
What are the typical daily responsibilities of a director analytical development?
A Director Analytical Development typically oversees the design, implementation, and optimization of analytical methods to support product development and quality control. This involves leading a team of scientists, ensuring projects meet regulatory requirements, troubleshooting technical challenges, and collaborating closely with cross-functional groups such as R&D, quality assurance, and manufacturing. Daily tasks often include reviewing analytical data and reports, planning project timelines, and making strategic decisions to align with organizational objectives. The role requires balancing hands-on scientific guidance with high-level management to drive innovation and efficiency within the analytical function.
What are the key skills and qualifications needed to thrive in the director analytical development position, and why are they important?
To thrive as a Director Analytical Development, you generally need an advanced degree in chemistry, biochemistry, or a related scientific field, along with substantial experience in analytical method development and validation, and team leadership. Familiarity with laboratory information management systems (LIMS), chromatographic and spectroscopic instrumentation, and regulatory guidelines such as ICH, FDA, and GMP is crucial. Excellent project management, strategic thinking, and interpersonal communication are standout soft skills for this position. These competencies enable effective oversight of complex analytical projects, ensure regulatory compliance, and foster team collaboration in a fast-paced R&D environment.
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Full-time
Posted 18 days ago
Job description
The Opportunity:
Associate Director QC will be responsible for oversight of the Quality Control testing at contract labs for drug substance, drug product, and stability programs across commercial and development portfolios. Partner cross-functionally within PDM (drug substance, drug product, CMC Regulatory Affairs) and QA to manage method transfers, validations, and data oversight aligned with development and production timelines. Key responsibilities include vendor oversight, data review, external audits, and management of GMP-related exceptions (e.g., deviations, CAPAs, OOS/OOT, change controls).
Oversees designation of critical quality attributes, specification setting, and trending of method and product performance. Provides direction on method transfers and validations, ensuring compliance with regulatory standards and laboratory control requirements.
Responsibilities:
Lead and/or coordinate QC activities of late phase and commercial programs, including but not limited to commercial launch readiness, in-process control test, final release test, PAI readiness and inspection as needed.
Oversee and manage outsourced commercial QC activities at CDMOs and/or contract testing labs (CTLs).
Manage quality events related to commercial QC testing such as lab investigation (e.g., OOS/OOT), deviations, change controls (e.g., CBE 30/CBE 0) and CAPAs.
Author and/or review commercial QC related documents, including methods, protocols, reports and memos.
Manage commercial phase reference materials including monitoring retest date, facilitating qualification/requalification, and tracking inventory.
Collaborate with cross functional teams including CMC RA, DS, DP, Supply Chain and Quality Assurance to timely achieve project goals.
Coach, mentor, and engage team to ensure business goals and development plans are met.
Establish and monitor operational metrics to track performance and identify trends
Monitor emerging regulatory requirements and assess organizational impact.
Lead remediation efforts for identified gaps and drive continuous improvement initiatives.
Excellent interpersonal, negotiation, and influencing skills with the ability to manage multiple priorities and lead change across all organizational levels.
Required Experience, Skills and Education:
Bachelor's degree in a scientific discipline with 15+ years of experience in pharmaceutical QC operations across development and commercial stages. Alternatively, a Master's degree with 12+ years or a PhD with 10+ years is acceptable.
Solid understanding of relevant global and regional regulatory guidelines (FDA, EU, and ICH, etc.) as applicable to QbD, commercial process validation, commercial product launch, commercial manufacture sampling and testing, and post-approval quality control requirements.
Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.).
Extensive knowledge and understanding of cGMP guidelines and practices, as well as related / best industry practices.
Strong problem-solving skills with sound technically driven decision-making ability.
Preferred Skills:
Small molecule experience is required; biologics experience is highly preferred.
Effective written and verbal communication skills and interpersonal skills.
Excellent scientific and business communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.
Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems .
Ability to multi-task and thrive in a fast-paced innovative environment.
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