Talent.com
Senior Director, Analytical Development and Quality Control
Senior Director, Analytical Development and Quality ControlAltos Labs • San Francisco, CA, US
Senior Director, Analytical Development and Quality Control

Senior Director, Analytical Development and Quality Control

Altos Labs • San Francisco, CA, US
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Senior Director, Analytical Development And Quality Control

Our mission is to restore cell health and resilience through cell rejuvenation to reverse disease, injury, and the disabilities that can occur throughout life.

Our single Altos value : Everyone Owns Achieving Our Inspiring Mission.

We believe that diverse perspectives are foundational to scientific innovation and inquiry. At Altos, exceptional scientists and industry leaders from around the world work together to advance a shared mission. Our intentional focus is on Belonging, so that all employees know that they are valued for their unique perspectives. We are all accountable for sustaining a diverse and inclusive environment.

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 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.
  • 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.

    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.

    Altos currently requires all employees to be fully vaccinated against COVID-19, subject to legally required exemptions (e.g., due to a medical condition or sincerely-held religious belief).

    [job_alerts.create_a_job]

    Director Development • San Francisco, CA, US

    [internal_linking.related_jobs]
    Director, Nonclinical Development

    Director, Nonclinical Development

    Amber Bio • Alameda, CA, US
    [job_card.full_time]
    Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits to reach previously undruggable patient populations. Founded by pioneers in the CRISPR field fr...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director / Director, Clinical Quality Assurance

    Associate Director / Director, Clinical Quality Assurance

    BridgeBio Pharma • San Francisco, CA, US
    [job_card.full_time]
    Associate Director / Director, Clinical Quality Assurance.When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excite...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Director, Sales Enablement Knowledge Management and Readiness

    Senior Director, Sales Enablement Knowledge Management and Readiness

    Visa • San Francisco, CA, United States
    [job_card.full_time]
    Visa is a world leader in payments and technology, with over 259 billion payments transactions flowing safely between consumers, merchants, financial institutions, and government entities in more t...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Manager, Mechanical Simulation & AnalysisMechanical Design Engineering • Berkeley, CA; Weirton, WV; Somerville, MA • Full time • On-site

    Senior Manager, Mechanical Simulation & AnalysisMechanical Design Engineering • Berkeley, CA; Weirton, WV; Somerville, MA • Full time • On-site

    Form Energy • Berkeley, CA, United States
    [job_card.full_time]
    Are you ready to build America's energy future? Form Energy is an American manufacturing and energy technology company.We're revolutionizing energy storage with cost-effective, multi-day technology...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Director, Quality Control Analytical Sciences

    Senior Director, Quality Control Analytical Sciences

    Apogee Therapeutics • Oakland, CA, US
    [job_card.full_time]
    Senior Director, Quality Control Analytical Sciences.We are seeking a Senior Director, Quality Control (QC) Analytical Sciences, to lead QC Analytical Sciences across Apogee's pipeline.This individ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director of Quality - MedTech, San Jose (Relocation)

    Director of Quality - MedTech, San Jose (Relocation)

    Vantedge Medical • San Francisco, CA, United States
    [job_card.full_time]
    A leading med-tech company is seeking a Director of Quality to oversee quality assurance efforts at their San Jose location. This role involves developing quality control systems, improving supplier...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Senior Director, Clinical Development

    Senior Director, Clinical Development

    Annexon Bioscience • San Francisco, CA, United States
    [job_card.full_time]
    At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammat...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director of Nursing ($5,000 Sign on Bonus)

    Director of Nursing ($5,000 Sign on Bonus)

    The Terraces at Los Altos - a HumanGood community • Sausalito, California, United States
    [job_card.full_time] +2
    Terraces at Los Altos, a distinguished HumanGood life plan community, is seeking a Director of Nursing (DON) for its Health Center team. Under limited supervision, the DON plans, directs, organizes,...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Senior Leader, Biologics Analytical Development

    Senior Leader, Biologics Analytical Development

    Gilead Sciences, Inc. • Foster City, CA, United States
    [job_card.full_time]
    A leading biopharmaceutical company is seeking a Principal Scientist in Analytical Ops in Foster City, California.The role involves leading analytical development, mentoring scientists, and ensurin...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    (Senior) Director of Chemistry

    (Senior) Director of Chemistry

    MedTech Innovator • Berkeley, CA, United States
    [job_card.full_time]
    At Glyphic Biotechnologies, we plan to create the protein revolution for which scientists and researchers have been waiting. We are developing a massively parallel, single-molecule proteome sequenci...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director, Data Analytics and Systems Development

    Associate Director, Data Analytics and Systems Development

    Corcept Therapeutics • Redwood City, CA, US
    [job_card.full_time]
    Associate Director, Data Analytics and Systems Development.Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucoc...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director, Manufacturing

    Director, Manufacturing

    Bio-Rad Laboratories • Hercules, CA, United States
    [job_card.full_time]
    We are seeking an experienced and strategic.This position creates and directs an integrated team that provides superior products and service to Bio-Rad life science's customers worldwide.Works clos...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director of the Lawrence Berkeley National Laboratory

    Director of the Lawrence Berkeley National Laboratory

    InsideHigherEd • Berkeley, California, United States
    [job_card.full_time]
    The President and the Regents of the University of California invite nominations and applications for the position of Director of the . Lawrence Berkeley National Laboratory.LBNL,” “Berkeley Lab,” o...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Global Quality Control Director — Lean Lab & Compliance

    Global Quality Control Director — Lean Lab & Compliance

    Gr?nenthal GmbH • Menlo Park, CA, United States
    [job_card.full_time]
    A global pharmaceutical leader is seeking a Quality Control Director in Menlo Park to lead the quality control function across their global manufacturing network. Responsibilities include implementi...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director of Partner & Vendor Quality Management

    Director of Partner & Vendor Quality Management

    Rigel Pharmaceuticals Inc. • San Francisco, CA, US
    [job_card.full_time]
    A leading pharmaceuticals company based in San Francisco is seeking a Director of Vendor and Partners Quality Management. The role involves strategic oversight of quality compliance with external pa...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director / Senior Director, Biostatistics

    Director / Senior Director, Biostatistics

    Penfield Search Partners Ltd • San Francisco, CA, United States
    [job_card.full_time]
    Our client is a biopharmaceutical company committed to researching, developing, and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases.Focusing on bringing ne...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Pipeline Analytics

    Associate Director, Pipeline Analytics

    BeiGene • San Carlos, CA, US
    [job_card.full_time]
    Associate Director, Pipeline Analytics.BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for sci...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director / Senior Director, CMC Lead

    Director / Senior Director, CMC Lead

    Valid8 Financial, Inc. • San Francisco, CA, United States
    [job_card.full_time]
    Director / Senior Director, CMC Lead.Department / Function : CMC / CMC Lead.Work Location : Corporate Headquarters (South San Francisco). TCG Labs-Soleil is looking for a top-notch CMC Lead to join our ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]