SupportFinity™
Director/Sr. Director, Analytical Development
SupportFinity™, South San Francisco, California, us, 94083
Director/Sr. Director, Analytical Development
Position Summary
Terremoto Biosciences is located in South San Francisco and is seeking a Director/Sr. Director of Analytical Development within the Technical Operations team. Reporting to the Head of Technical Operations, the incumbent will be required to work flexibly across multiple small molecule programs with responsibilities including but not limited to managing all internal/external analytical development activities across various stages of development, overseeing analytical and QC activities at trusted CDMO partners and contract testing labs, ensuring compliance with regulatory standards, and working cross-functionally with key stakeholders.
Key Responsibilities
Act as the analytical technical lead for multiple small molecule programs
Provide technical leadership while working with cross-functional team members
Develop strategies and oversee the execution of analytical activities associated with both drug substance and drug product development and manufacturing, supporting clinical development, and regulatory filings
Lead phase appropriate analytical method development and transfer, qualification and validation activities, in-process/release/stability testing, setting of specifications, product characterization, and quality control activities
Foster and contribute to a team culture of scientific rigor, accountability, and inclusivity through the management/mentorship of internal FTEs and supporting professional development
Effectively communicate progress (reports and presentations) regarding all drug substance/product related activities to key stakeholders both internally and externally
Author, review, and/or approve development/stability reports, specifications, controlled documents, standard operating procedures, deviation/investigation reports, and required sections of regulatory submissions
Travel to CDMOs for vendor assessment, troubleshooting, qualification, and/or analytical testing oversight as needed
Qualifications
Ph.D. in Analytical Chemistry or related field with 8+ years of experience in the pharmaceutical/biotech industry with a strong track record of technical expertise, leadership, and analytical development and quality control experience across various stages of development with small molecules
Extensive experience with the management of CDMOs and contract testing labs
Thorough understanding and working experience of pharmaceutical drug substance and drug products concerning cGMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements
Strong understanding of drug development process from preclinical through late-stage development
Strong organizational and leadership skills with the ability to effectively manage multiple priorities and clearly communicate results both written and verbally
The anticipated salary range for candidates who will work in South San Francisco, CA is $235,000 to $260,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Terremoto Biosciences, is a multi-state employer and this salary range may not reflect positions that work only in other states.
We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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Key Responsibilities
Act as the analytical technical lead for multiple small molecule programs
Provide technical leadership while working with cross-functional team members
Develop strategies and oversee the execution of analytical activities associated with both drug substance and drug product development and manufacturing, supporting clinical development, and regulatory filings
Lead phase appropriate analytical method development and transfer, qualification and validation activities, in-process/release/stability testing, setting of specifications, product characterization, and quality control activities
Foster and contribute to a team culture of scientific rigor, accountability, and inclusivity through the management/mentorship of internal FTEs and supporting professional development
Effectively communicate progress (reports and presentations) regarding all drug substance/product related activities to key stakeholders both internally and externally
Author, review, and/or approve development/stability reports, specifications, controlled documents, standard operating procedures, deviation/investigation reports, and required sections of regulatory submissions
Travel to CDMOs for vendor assessment, troubleshooting, qualification, and/or analytical testing oversight as needed
Qualifications
Ph.D. in Analytical Chemistry or related field with 8+ years of experience in the pharmaceutical/biotech industry with a strong track record of technical expertise, leadership, and analytical development and quality control experience across various stages of development with small molecules
Extensive experience with the management of CDMOs and contract testing labs
Thorough understanding and working experience of pharmaceutical drug substance and drug products concerning cGMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements
Strong understanding of drug development process from preclinical through late-stage development
Strong organizational and leadership skills with the ability to effectively manage multiple priorities and clearly communicate results both written and verbally
The anticipated salary range for candidates who will work in South San Francisco, CA is $235,000 to $260,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Terremoto Biosciences, is a multi-state employer and this salary range may not reflect positions that work only in other states.
We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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