Job Title: Director/Senior Director of Analytical Development
Location: South San Francisco, CA
Company: [Confidential Biotech Company]
About the Company: This clinical-stage biotechnology company is dedicated to revolutionizing the treatment of heart disease. Their mission is to develop curative therapies that address the underlying causes of heart disease through innovative product platforms. With a robust pipeline, significant funding, and a leadership team composed of industry veterans, the company is well-positioned for success.
Position Overview: The company is seeking a highly motivated and experienced Director or Senior Director of Analytical Development to join their team. This is a unique opportunity to lead analytical development efforts, particularly focusing on adeno-associated virus (AAV) vectors, and make a significant impact on their mission to transform heart disease treatment.
Why Join the Company?
- Innovative Pipeline: The company boasts a strong pipeline of groundbreaking therapies targeting the root causes of heart disease. Their focus on AAV vectors and other advanced modalities positions them at the cutting edge of biotechnology.
- Strong Funding: Backed by substantial funding from top-tier investors, the company has the financial stability and resources to drive its ambitious research and development programs forward.
- Experienced Leadership: The leadership team is composed of industry veterans with a proven track record of success in biotechnology. Their expertise and vision are driving the company towards achieving its mission34.
- Collaborative Culture: The role involves close collaboration with cross-functional teams, including Manufacturing, Regulatory, and Quality, to support technology transfers and regulatory submissions.
- Professional Growth: The company offers opportunities for professional development and career advancement, valuing contributions and fostering innovation.
- Impactful Work: The candidate will contribute to life-changing therapies that have the potential to revolutionize heart disease treatment and improve patient outcomes.
Key Responsibilities:
- Provide strategic, managerial, and technical leadership to the Analytical Development team.
- Design and execute phase-appropriate analytical strategies, including method development, qualification, and validation for AAV drug substances and drug products.
- Develop and set specifications for raw materials, intermediates, drug substances, excipients, and drug products.
- Establish and manage stability programs for non-GMP and cGMP drug substance and drug product batches.
- Oversee the review of raw data packages associated with method qualifications/validations, release testing, stability testing, and other characterization testing.
- Support regulatory submissions by drafting and reviewing analytical sections of INDs, IMPDs, and NDAs.
- Ensure compliance with ICH guidelines and maintain a strong quality system around drug substances and products.
Qualifications:
- Ph.D. in Chemistry, Pharmaceutical Sciences, or a related discipline with 10+ years of industry experience, or BS/MS degree with 15+ years of industry experience.
- Extensive experience in analytical development of AAV vectors and solid oral dosage forms from preclinical to late-stage clinical development.
- Proven expertise in analytical techniques such as HPLC, GC, FTIR, UV-Vis, and other USP and EP methods.
- Strong understanding of cGMP requirements, ICH, FDA, USP, EP, and other pharmaceutical industry regulatory guidelines.
- Excellent leadership, communication, and project management skills.
- Ability to work in a fast-paced environment and manage multiple projects simultaneously.
