About This Role
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:
A minimum of 15 years of experience in pharmaceutical/biopharmaceutical analytical development.
A minimum of 3 years of experience working with small molecule or antisense oligonucleotides
At least 6 years of experience in a managerial capacity
Extensive expertise in analytical method development and control strategy for small molecules and/or antisense oligonucleotides.
In-depth knowledge of analytical methods and regulatory requirements.
Strong analytical and problem-solving abilities.
Proven track record in preparing Module 3 sections for regulatory submissions.
Bachelor's degree in a related field
Preferred Skills:
PhD is preferred.
Demonstrated ability in leading cross-functional teams and projects.
Experience in driving operational excellence and process optimization within a team.
Capability to foster innovation and integrate new technologies into analytical development practices.
Additional Information
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:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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.Read onto learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.