- Design and execution of laboratory experiments supporting process development for the continuous improvement of Biogen's oligonucleotide manufacturing platforms
- Execution of formulation and process development study protocols, stability and product characterization studies
- Development and on-site support of cGMP drug product manufacturing processes
- Closely interfacing with chemical synthesis, purification and analytical groups to support oligonucleotide manufacturing platforms
- Coordinating pre-clinical test article supply with Research scientists
- Writing protocols, performing data analysis, and authoring reports
- Authoring and reviewing all necessary SOPs, protocols, and study reports, as well as common technical documentation for regulatory submissions
- Capable of working independently, eager to learn new concepts, and bring a can-do attitude
- Presenting scientific data to technical teams, ability to manage several projects simultaneously, and excellent communication skills, both written and oral.
- Ph.D. in Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering or related field with 0 - 4 years' experience in pharmaceutical or biotech settings. (including Ph.D. candidates graduating in Spring-Summer, 2024)
- OR M.S. degree with 4+ to 6 years of relevant experience
- OR B.S. degree with 6+ to 8 years of relevant experience
- Familiar with pharmaceutical development.
- Demonstrated experience with sterile drug product development and parenteral formulations preferably with hands-on experience with oligonucleotides.
- Understanding of drug product manufacturing process operations such as mixing, sterile filtration, extractable/leachable assessments, and container filling/closing.
- Experience in analytical and characterization methods such as chromatography, spectroscopy, calorimetry and particle analysis technologies.
- Knowledge of statistical software, design or experiment programming and general visualization of sophisticated data sets is a plus.
- Prior experience working in a biopharmaceutical product development environment and familiarity with GMP guidelines is preferred.
- Experience in developing and analyzing drug delivery systems, such as polymeric and lipid nanoparticles is a plus.
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Scientist II, ASO Formulation and Drug Product Development - Cambridge, United States - Biogen Idec
Description
Job Description
About This Role
Biogen is presently looking to fill a Scientist II position within its Anti-Sense Oligonucleotide (ASO) Formulation and Drug Product Development group. The candidate will be responsible for formulation and process development activities of oligonucleotide drug product programs to support Biogen's growing pipeline. Candidate is expected to work collaboratively in a matrix environment with other members of the technical development team. The candidate must be motivated and innovative with exceptional analytical and communication skills.
This is a hybrid role to be based at our headquarters in Cambridge, MA.
What You'll Do
Who You Are
You have general knowledge of parenteral drug product development and manufacturing. You will be part a dynamic oligonucleotide drug product development group consist of scientists and engineers. You will be working closely with the Pharma Process Development and Regulatory CMC team as well as R&D, Manufacturing and Quality teams to support development activities of Biogen oligonucleotide programs. You have passion for learning and proactive attitude to drive success in your new role. You enjoy and thrive in a fast-paced team/matrix environment as well as working independently to manage priorities and maintain project timeline. Your dedication to excellence and your ability to adapt to a dynamic, matrixed organization will be key assets in achieving our collective goals.
Education Requirements:
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
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.
