Senior Director, Analytical Development and Quality Control jobs in United States
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Altos Labs · 1 day ago

Senior Director, Analytical Development and Quality Control

Altos Labs is dedicated to restoring cell health and resilience through innovative cell rejuvenation technologies. They are seeking a highly experienced analytical and QC leader to oversee analytical development and quality control for various therapeutic programs, including protein therapeutics and gene therapy.

BiopharmaBiotechnologyHealth CareHealth DiagnosticsMedical
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H1B Sponsor Likelynote

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

Qualification

Ph.D. in analytical sciences15+ years analytical experienceQuality Control testingCGMP complianceCMC leadership experienceMultiple modalities experienceCommunication skillsCritical thinkingCollaboration skills

Required

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 cGMP's 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

Company

Altos Labs

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Altos Labs focuses on cellular rejuvenation programming to restore cell health and resilience, to reverse disease to transform medicine.

H1B Sponsorship

Altos Labs has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (7)
2023 (5)
2022 (6)

Funding

Current Stage
Growth Stage
Total Funding
$3B
2021-01-01Series A· $3B

Leadership Team

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Joan Mannick
Chief Medical Officer
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Company data provided by crunchbase