Altos Labs
Senior Director, Analytical Development and Quality Control
Altos Labs, San Francisco, California, United States, 94199
Overview
Senior Director, Analytical Development and Quality Control — Altos Labs
Join to apply for the Senior Director, Analytical Development and Quality Control role at Altos Labs.
Our mission is to restore cell health and resilience through cell rejuvenation to reverse disease, injury, and the disabilities that can occur throughout life. For more information, see our website at altoslabs.com.
What You Will Contribute To Altos The Altos Institute of Medicine will capture knowledge generated about cell health and programming and develop transformative medicines. We are seeking a highly experienced analytical and QC leader to join the Technical Operations team as the Head of Analytical Development and Quality Control. The candidate will work in a highly dynamic and cross-functional environment that will have close collaboration with the Institutes of Science and span multiple therapeutic areas. The successful candidate will lead analytical development and quality control for Altos programs. Modalities include protein and antibody therapeutics, small molecules, antisense oligonucleotides, mRNA and AAV gene therapy.
Responsibilities
Lead analytical development and quality control across multiple modalities
Build a high performing team and establish internal and external analytical and QC capabilities
Serve as CMC lead and analytical lead for Altos therapeutic programs
Manage contract manufacturing organizations and CROs to develop and qualify analytical testing methods, perform product characterization, release and stability testing, and in-process testing
Establish product specifications to ensure product quality. Support technical assessment of Out of Specification and Non-Conforming investigations.
Author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents
As a member of the Tech Ops leadership team, build the Tech Ops organization, processes, systems and infrastructure
Create and foster strong partnerships with Institutes of Science, Institutes of Technology, Institute of Computation, drug discovery and development sciences, clinical, regulatory, program management, business development, legal and finance
Actively contribute to a team culture that promotes continuous improvement, accountability, professional growth, and inclusion
Qualifications
Ph.D. in analytical sciences or biological sciences. Minimum 15+ years of analytical development and QC experience in biotech/pharmaceutical industry. 10+ years of Management experience.
Highly experienced in developing and implementing assays for Quality Control testing and characterization of drug substance, drug product and manufacturing in-process samples
Experienced in multiple modalities including biologics, oligonucleotides, small molecules, mRNA/LNP and AAV gene therapy.
Experienced in leading CMC team and analytical subteam
Proficient in cGMPs and pharmaceutical industry procedures and regulations
Highly experienced in achieving CMC deliverables through outsourcing to Contract Manufacturing Organizations. Leadership experience in managing diverse project activities with contract CDMO facilities at global locations
A critical thinker with the ability to analyze possibilities and solutions and make pragmatic trade-offs, as well as a big-picture innovator who can identify opportunities and is comfortable with ambiguity
Strong communication and collaboration skills. Clear and influential communicator. Build effective relationships and partnerships with internal and external stakeholders
Proven capability to lead, motivate and inspire in a diverse, global, cross-functional structure and commit to diversity, equity, and belonging
Salary The salary range for Redwood City, CA: Senior Director, Analytical Development: $283,900 - $384,100. Exact compensation may vary based on skills, experience, and location.
Equal Opportunity Employment Altos Labs provides equal employment opportunities to all employees and applicants for employment, without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Altos prohibits unlawful discrimination and harassment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Note: Altos Labs will not ask you to download a messaging app for an interview or outlay your own money to get started as an employee. If this sounds like your interaction with people claiming to be with Altos, it is not legitimate and has nothing to do with Altos. Learn more about a common job scam at https://www.linkedin.com/pulse/how-spot-avoid-online-job-scams-biron-clark/
Note For UK applicants, before submitting your application: read the Altos Labs EU and UK Applicant Privacy Notice. This Privacy Notice is not a contract, express or implied and it does not set terms or conditions of employment.
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Join to apply for the Senior Director, Analytical Development and Quality Control role at Altos Labs.
Our mission is to restore cell health and resilience through cell rejuvenation to reverse disease, injury, and the disabilities that can occur throughout life. For more information, see our website at altoslabs.com.
What You Will Contribute To Altos The Altos Institute of Medicine will capture knowledge generated about cell health and programming and develop transformative medicines. We are seeking a highly experienced analytical and QC leader to join the Technical Operations team as the Head of Analytical Development and Quality Control. The candidate will work in a highly dynamic and cross-functional environment that will have close collaboration with the Institutes of Science and span multiple therapeutic areas. The successful candidate will lead analytical development and quality control for Altos programs. Modalities include protein and antibody therapeutics, small molecules, antisense oligonucleotides, mRNA and AAV gene therapy.
Responsibilities
Lead analytical development and quality control across multiple modalities
Build a high performing team and establish internal and external analytical and QC capabilities
Serve as CMC lead and analytical lead for Altos therapeutic programs
Manage contract manufacturing organizations and CROs to develop and qualify analytical testing methods, perform product characterization, release and stability testing, and in-process testing
Establish product specifications to ensure product quality. Support technical assessment of Out of Specification and Non-Conforming investigations.
Author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents
As a member of the Tech Ops leadership team, build the Tech Ops organization, processes, systems and infrastructure
Create and foster strong partnerships with Institutes of Science, Institutes of Technology, Institute of Computation, drug discovery and development sciences, clinical, regulatory, program management, business development, legal and finance
Actively contribute to a team culture that promotes continuous improvement, accountability, professional growth, and inclusion
Qualifications
Ph.D. in analytical sciences or biological sciences. Minimum 15+ years of analytical development and QC experience in biotech/pharmaceutical industry. 10+ years of Management experience.
Highly experienced in developing and implementing assays for Quality Control testing and characterization of drug substance, drug product and manufacturing in-process samples
Experienced in multiple modalities including biologics, oligonucleotides, small molecules, mRNA/LNP and AAV gene therapy.
Experienced in leading CMC team and analytical subteam
Proficient in cGMPs and pharmaceutical industry procedures and regulations
Highly experienced in achieving CMC deliverables through outsourcing to Contract Manufacturing Organizations. Leadership experience in managing diverse project activities with contract CDMO facilities at global locations
A critical thinker with the ability to analyze possibilities and solutions and make pragmatic trade-offs, as well as a big-picture innovator who can identify opportunities and is comfortable with ambiguity
Strong communication and collaboration skills. Clear and influential communicator. Build effective relationships and partnerships with internal and external stakeholders
Proven capability to lead, motivate and inspire in a diverse, global, cross-functional structure and commit to diversity, equity, and belonging
Salary The salary range for Redwood City, CA: Senior Director, Analytical Development: $283,900 - $384,100. Exact compensation may vary based on skills, experience, and location.
Equal Opportunity Employment Altos Labs provides equal employment opportunities to all employees and applicants for employment, without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Altos prohibits unlawful discrimination and harassment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Note: Altos Labs will not ask you to download a messaging app for an interview or outlay your own money to get started as an employee. If this sounds like your interaction with people claiming to be with Altos, it is not legitimate and has nothing to do with Altos. Learn more about a common job scam at https://www.linkedin.com/pulse/how-spot-avoid-online-job-scams-biron-clark/
Note For UK applicants, before submitting your application: read the Altos Labs EU and UK Applicant Privacy Notice. This Privacy Notice is not a contract, express or implied and it does not set terms or conditions of employment.
#J-18808-Ljbffr