Senior Director, Analytical Development

Senior Director And Head Of Analytical Development For Small Molecules & Antisense Oligonucleotides

As the Senior Director and Head of Analytical Development for Small Molecules & Antisense Oligonucleotides, you will spearhead the advancement and refinement of analytical methods and control strategies critical to our small molecule and antisense oligonucleotide portfolio. Reporting to the Head of Pharma CMC Development and Regulatory, your leadership will be instrumental from R&D transition through to commercialization. You will offer comprehensive expertise in product characterization, ensuring robust support throughout the product lifecycle and in response to comparability assessments. Your role extends to testing commercial products and establishing an early phase clinical testing team under phase-appropriate GMP controls.

What You'll Do

• Lead and qualify analytical methods for the small molecule and antisense oligonucleotide portfolio.
• Ensure processes for documenting and transferring analytical methods to Quality Control and external facilities are in place.
• Characterize new products to support regulatory submissions and lifecycle comparability.
• Provide leadership to a scientific team of 20+ individuals, managing workload, productivity, and regulatory compliance.
• Support clinical to commercial analytical methods, improving productivity, reliability, and managing complex investigations.
• Drive innovation in analytical method development for small molecules and antisense oligonucleotides.
• Oversee critical sections of IND and NDA submissions, and respond to health authority inquiries.

Who You Are

You are a seasoned leader with a rich background in analytical development, with experience in small molecules and antisense oligonucleotides. Your leadership skills have been honed through years of managing and nurturing large teams. You approach challenges with a solutions-focused mindset and have a history of effectively responding to regulatory agencies. A continuous improvement mindset propels you to strive for excellence in all aspects of your work. You are adept at guiding organizational change and possess the qualities of a strong mentor and coach for a dynamic team.

Required Skills :

Preferred Skills :

Job Level : Management

Additional Information

The base compensation range for this role is : $220,000.00-$303,000.00. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to :

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.