Job Description
About This Role
The Sr. Director and Head, Analytical Development (AD)- Small Molecules & Antisense Oligonucleotides will be responsible for leading the development and optimization of all analytical methods and control strategies for our portfolio of small molecules (SMs) and antisense oligonucleotides (ASOs) from transition from R&D through commercialization. This leader will provide in depth expertise and guidance for the characterization of SM and ASO products as part of new product development and to support comparability when required throughout the product lifecycle. This leader will also be responsible for testing existing commercial products where needed and to oversee the development of a team for early phase clinical testing under phase appropriate GMP controls.
This is a senior leadership role with oversight for ~20-25 direct FTEs and additional indirect oversight of activities within manufacturing facilities, contract laboratory organizations and R&D. This role requires excellent cross functional influencing skills and strategic vision to maintain Biogen's position at the forefront of SMs and ASOs process development in terms of productivity and reliability. In addition, this leader will have significant responsibility for the oversight of critical sections for IND and NDAA submissions and will be accountable to respond to queries from health authorities. This role reports into the Head of Pharma Process Development and Regulatory CMC.
What You'll Do
* Analytical Method development: Lead the development and qualification (if required) of analytical methods for SMs and ASOs
* Accountable for the establishment of processes to document and transfer analytical methods to Quality Control, external testing labs and other contract manufacturing organizations
* Product characterization to characterize new products as part of the required data to support INDs, NDA/MAA and to support comparability during the product lifecycle
* Team leadership: Provide technical and developmental leadership to a team of scientists to ensure processes are in place to manage workload, assess capacity, drive productivity and drive compliance with appropriate regulatory requirements including data integrity
* Clinical Commercial support: This leader will provide end to end support to all analytical methods in terms of driving YoY productivity, improving reliability and to support complex investigations to ensure supply in addition to managing commercial testing where required and will establish an early phase clinical testing capability
* Technology advancement: This leader will be responsible to ensure continued innovation for analytical method development for both SMs and ASOs including our platform and more complex molecules
Qualifications
Who You Are
You are an experienced leader in analytical development with expertise in small molecules/antisense oligonucleotides. You have a track record of successful managing and developing large teams. You are solution oriented and possess in-depth experience addressing regulatory agency inquires.
Required Skills
* Minimum 15 years of experience in pharma/biopharma setting and analytical development.
* Proven experience in leading and managing teams in a laboratory setting
* Demonstrated expertise analytical method development and control strategy for SM and/or ASO
* Extensive knowledge of analytical method requirements and regulatory requirements
* Strong analytical and problem solving skills
* Excellent communication and presentation skills
* Experience in the preparation of Module 3 sections and prior engagement with regulatory authorities
Education
Bachelor's degree in a related field required. PhD preferred.
Additional Information
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 on to 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.