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Associate Director, MFG Sciences
2 months ago
About This Role
As the leader of the Manufacturing Sciences Process Transfer within the Antisense Oligonucleotide (ASO) and Oral Solid Dosage (OSD) manufacturing areas, you will manage a group of engineers and scientists who are responsible for performing tech transfers to the clinical and commercial manufacturing campaigns run at Biogen’s RTP Pharma Site.
What You'll Do
- Manage a team of process/technical experts that perform Technology Transfer of internal/partner programs into Biogen’s RTP Pharma Manufacturing site
- Hire, develop, motivate, coach and deploy highly functioning team of process transfer engineers/scientists
- Develop and drive team performance, objectives, direction, goals and priorities
- Serve as a scientific and technical lead for major process transfer related issues/investigations at the site
- Develop relationships with external business partners and internal stakeholder groups, including (but not limited to) manufacturing, engineering, automation, technical development, quality, materials, etc.
- Communicate effectively to department and site leadership and within internal/external forums as appropriate
- Lead technical projects towards improved facility capabilities, efficient systems, improved technical competency, or increased process/scale-up understanding. Cultivate continuous improvement environment within the process transfer teams at the RTP site and benchmark tech transfer best practices both internal and external to Biogen, as appropriate
- Lead/guide optimization projects resulting in improved (simplified, more robust, or clearer) business processes
- Manage routine data trending of manufacturing data to fulfill regulatory/compliance requirements. This includes authoring quarterly trend reports and annual product reviews
- Author technical protocols/reports and regulatory documents
- Maintain current knowledge of oral solid dosage manufacturing processes
- Support inspections and audits, both internally and for regulatory agencies
Required:
- Bachelor's Degree plus a minimum 10 years of relevant experience in the Biotech/Biopharma industry or M.S. with a minimum of 8 years of experience or Ph.D. with a minimum of 5 years of experience
- Solid technical understanding of Oligonucleotide Synthesis Manufacturing and Oral Solid Dosage manufacturing including transfer of such processes into full-scale drug product manufacturing facilities
- Experience managing a group of technical SMEs is preferred
- Ability to work independently, lead a large cross-functional group and interact with site leadership team
- Good communication and project management skills
- Comfortable analyzing scientific datasets/strong analytical skills with excellent written skills
- Knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification, Continued Process Verification
- Knowledge of downstream purification processing specifically related to chromatography separation methodology and ultra filtration diafiltration operations
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.
