Senior Scientist, Drug Product Process Development and Manufacturing

Company: Tbwa Chiat/Day Inc
Location: San Francisco
Posted on: April 2, 2025

Job Description:

Senior Scientist, Drug Product Process Development and ManufacturingOur MissionOur mission is to restore cell health and resilience through cell rejuvenation to reverse disease, injury, and the disabilities that can occur throughout life.Diversity at AltosWe 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.What You Will Contribute To AltosWe are seeking a highly experienced senior scientist in drug product process development and manufacturing to join the Technical Operations team within the Institute of Medicine. The candidate will work in a highly dynamic and cross-functional environment. The successful candidate will lead formulation and drug product process development and support outsourced GMP manufacturing for Altos programs. Modalities include AAV gene therapy, mRNA, and protein therapeutics.Responsibilities

• Lead formulation and drug product process development for AAV gene therapy, mRNA-LNP, and protein therapeutics.
• Establish internal drug product process development capabilities, design and conduct experiments to develop stable and effective drug formulations, including selection of excipients, concentration optimization, and compatibility studies. Produce materials to supply non-clinical studies.
• Develop and scale-up manufacturing processes for various drug delivery systems considering critical process parameters (CPPs) and critical quality attributes (CQAs). Utilize statistical analysis and experimental design to identify and improve process parameters, maximizing product yield and quality consistency.
• Conduct stability testing to assess the long-term integrity of drug products under various storage conditions and identify potential degradation pathways.
• Manage and collaborate with CDMOs to optimize/improve DP manufacturing processes, scale up, and establish in-process control strategies.
• Support GMP manufacturing at CDMOs, review GMP documents, troubleshoot technical issues, support deviation investigation, and lead risk assessment.
• Collaborate cross-functionally with analytical development, quality control QA, Institutes of Science, development sciences, clinical, regulatory, program management, legal, and finance, through the lifecycle of the product.
• Author, review, and/or approve development reports, regulatory filing, or other controlled documents.
• Recruit and provide direction and leadership to development associates as the team expands.
• Stay abreast of industry trends, emerging technologies, and regulatory guidelines to contribute to the continuous improvement of processes and compliance.
• Actively contribute to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion.Who You AreQualifications
  • PhD in chemical engineering, biochemical engineering, biotechnology, or related field of biological sciences. Minimum 8+ years of cell culture process development experience in the biotech/pharmaceutical industry.
  • Proven expertise in formulation and process development for liquid and lyophilized drug products. Experience in multiple modalities--AAV gene therapy, protein, and mRNA-LNP therapeutics, is a plus.
  • Experience with new product development, formulation development, process optimization, technical transfers to CDMOs, and statistical design and analysis of experiments.
  • Experience with unit operations (i.e., filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up.
  • Understanding of physical/chemical stability of proteins and how process-related stress impacts product quality.
  • Experienced in achieving CMC deliverables through outsourcing to CDMOs.
  • Strong problem-solving skills with the ability to interpret complex data sets.
  • Knowledge of regulatory requirements and quality standards related to biopharmaceutical manufacturing.
  • Ability to work in a dynamic environment, with a willingness to learn new skills and adapt to shifting priorities and tasks.
  • Excellent communication skills. Proven capability to collaborate effectively in a diverse, global, cross-functional structure and commit to diversity, equity, and belonging.Salary RangeThe salary range for Redwood City, CA:
    • Scientist I: $123,250 - $166,750
    • Scientist II: $145,000 - $202,800
    • Senior Scientist I: $169,000 - $234,000
    • Senior Scientist II: $195,000 - $261,600Exact compensation may vary based on skills, experience, and location.Equal Opportunity EmploymentAltos Labs provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type 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.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).Thank you for your interest in Altos Labs where we strive for a culture of scientific excellence, learning, and belonging.
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Keywords: Tbwa Chiat/Day Inc, San Francisco , Senior Scientist, Drug Product Process Development and Manufacturing, Accounting, Auditing , San Francisco, California