Director, Analytical Development and QC - Biologics

The Director, Analytical Development and QC - Biologics at Formation Bio is responsible for leading analytical development for pre-clinical and clinical-stage large molecule therapeutics. This includes overseeing analytical activities at contract development and manufacturing organizations (CDMOs), managing method validation, supporting regulatory submissions, and ensuring compliance with GxP regulations. You will also troubleshoot technical issues and lead cross-functional collaborations to facilitate smooth operations in the drug development lifecycle.

Candidates for the Director, Analytical Development and QC - Biologics role at Formation Bio should possess an MS or Ph.D. in Analytical Chemistry, Biochemistry, or a related discipline, along with a minimum of 7 years of experience in large molecule analytical development. Experience in leading CMC teams, expertise in analytical methods pertinent to biopharmaceuticals, and familiarity with regulatory submissions such as INDs and BLAs are essential for this position.

The Director, Analytical Development and QC - Biologics role at Formation Bio significantly contributes to drug development by providing technical leadership in optimizing and validating analytical methods for large molecules. This ensures the quality and efficacy of drug candidates as they move through pre-clinical and clinical stages, ultimately helping to expedite the delivery of new treatments to patients. Your guidance will also influence the selection of CDMOs and contract laboratories, helping to cultivate valuable partnerships.

Formation Bio stands out as a unique workplace due to its innovative approach to pharma, leveraging cutting-edge technology and AI to revolutionize drug development. As a Director, Analytical Development and QC - Biologics, you will be part of a mission-driven team that shares a commitment to improving patient outcomes and accelerating the delivery of new therapies. The collaborative culture encourages input from all team members, ensuring that your insights will make a real impact.

The target salary range for the Director, Analytical Development and QC - Biologics role at Formation Bio is between $250,000 - $300,000 for candidates based in the NYC Metro Area, Boston Metro Area, and SF Bay Area. For remote positions, the salary range can be between $238,000 - $285,000. Additionally, Formation Bio offers equity, generous perks, hybrid flexibility, and comprehensive benefits.

In your response, be specific about your previous roles where you led analytical development for large molecules. Highlight any methodologies you utilized, such as qPCR, HPLC, or ELISA, and discuss how these experiences will help in the Director role at Formation Bio.

When answering this question, use the STAR method (Situation, Task, Action, Result) to structure your response. Share a specific challenge, the steps you took to resolve it, and the outcome. This will demonstrate your problem-solving skills and industry knowledge.

Explain your approach to prioritization, such as using project management tools or frameworks. Mention how you communicate with team members to ensure that deadlines are met while maintaining quality, which is crucial for the Director position.

Discuss the importance of building strong, collaborative relationships with external partners. Mention specific strategies you use to foster communication and ensure alignment on project goals, which is essential in the Director role at Formation Bio.

Describe your knowledge of GxP regulations and practical steps you take to ensure compliance, such as conducting audits, training personnel, and regularly reviewing standard operating procedures. This knowledge is vital for the Director role.

Talk about methodologies you have utilized in the past, providing context around why you favor them based on factors like reproducibility, accuracy, and time efficiency. Your answer should reflect your expertise in large molecule analytics.

Share a specific example of an innovative approach you took to solve a problem or improve a process in analytical development. Be precise about the results and how they benefited your team or organization.

Discuss resources you utilize, such as industry conferences, journals, or networking with peers, to stay informed. Emphasize your commitment to continuous learning, which aligns well with the role at Formation Bio.

Outline your approach to technology transfer, focusing on collaboration with relevant teams, thorough documentation, and training of personnel. Highlight the importance of a seamless transition to maintain project timelines.

Express your alignment with Formation Bio’s mission to revolutionize the pharmaceuticals industry. Mention specific aspects of the company that excite you, such as its innovative use of technology in drug development and commitment to patient outcomes.