Job Description

Summary:

We are seeking a highly motivated and creative engineer or scientist with some process development experience to join our Oligonucleotide Purification Development team. This position provides an exciting opportunity to develop robust, high purity, state of the art processes for the purification of oligonucleotides. This position provides an exciting opportunity to gain hands-on experience and exposure to the design and development of manufacturing processes for clinical and commercial therapeutics. We are looking for someone who is passionate for exploring novel scientific ideas and play a key role in developing new cutting-edge technologies with a vision to push Biogen s state-of-art science in oligonucleotide purification that can ultimately impact patient lives.

Job Description:

This engineer II/ III role in the oligonucleotide development modality is responsible for purification development including process development, process characterization, scale-up, for all unit operations (chromatography, detritylation, UF/DF) with some guidance. This position is expected to learn our oligonucleotide platform while exploring non-platform and novel purification steps, have a working knowledge of the manufacturing facilities and equipment, contribute to tech transfer activities, document review, provide on-the-manufacturing floor support, troubleshooting and authoring CMC section of INDs. These activities can include early and late-stage process characterization and robustness studies. This position will act as a subject matter expert on purification processes to facilitate interactions internally within the oligonucleotide organization (synthesis, drug product, analytical) as well as cross functionally (with Research/Manufacturing/MS project and tech transfer teams). The ability to write development reports, training/mentoring of new employees, lead pilot scale activities and collaborate across teams or lead small, focused initiatives are important. Some independent work is expected (e.g., root cause investigations, evaluation of processes) with some guidance from the supervisor.

Responsibilities:

Develop and characterize purification processes for a rapidly expanding pipeline of new oligonucleotides drug therapies. The individual will utilize multiple modes of chromatography and ultrafiltration and learn chemical cleavage/conjugation/hybridization steps.

Investigate new purification technologies that seek to enhance purity, process robustness and/or productivity of our existing oligonucleotide platform process.

Collaborate cross-functionally with other groups to improve process understanding and manage team activities.

Document laboratory work in development reports, training/mentoring of new employees, and lead pilot scale activities.

Scale-up and technology transfer oligonucleotide processes into our pilot and GMP manufacturing facilities and participate in writing regulatory sections for INDs.