Sr. Scientist, Drug Product Development

Interius BioTherapeutics Is Seeking a Sr. Scientist, Drug Product Development to join us on our incredible journey

Can you see yourself as part of a growing team engineering cells inside the human body for the treatment of devastating diseases? That’s what Interians are doing, right now. We are developing new methods for in-vivo cell engineering at the forefront of advanced genetic therapies and medical innovation. We are a rapidly evolving organization, where those who enjoy the challenges and rewards of company-building will thrive.

As a highly motivated and creative scientist, you will bring your hands-on bench skills to support our novel lentiviral vector products. You will join the Drug Product Development team responsible for formulation and drug product process development, scale-up, and technology transfer for novel viral vectors being developed for in vivo gene therapy. Working alongside other scientists, you will contribute your expertise in supporting drug product activities including developing and defining the drug product strategy for multiple products. As the successful candidate, you will embrace the “roll-up your sleeves” biotech start-up culture where you are not only an amazing scientist but also eager and excited to jump in and experience new things.

“We not only hire great talent, we hire good people” is how our CEO, Phil Johnson, addressed the company at a recent meeting. “People who others like to work with.” If you like what you read and can see yourself as an Interian, please apply.

Responsibilities:

• Independently lead, design, and execute various steps of viral vector formulation and drug product process, including formulation, filling, freezing and drug product characterization and stability studies.
• Plan and lead experimental logistics, including scheduling, preparing/sourcing materials/media/buffers, and other consumables/reagents.
• Develop viral vector drug product characterization methodologies including but not limited to particle sizing techniques, flow cytometry, flow imaging and other virus characterization technologies.
• Design and conduct studies to select container closure, define storage conditions, dose preparation & administration instructions for pre-clinical and clinical studies.
• Provide technical supervision and support people development through direct and/or matrix leadership.
• Drive innovation for viral vector formulation and drug product process development including internal and external presentations, IP filings, and evaluation of new technologies.
• Be responsible for data collection, management, integrity and accuracy. Analyze and present data at team meetings and write technical reports.
• Participate and lead technology transfer of Drug product process and provide oversight as person in plant during manufacturing.
• Author and review documents including development reports, pharmacy manual, regulatory filing documents (Pre-IND, IND, IMPD, BLA, MAA) and internal purposes.
• Contribute to a culture of scientific excellence and advancement, including knowledge of current landscape and external engagement with CDMOs and other partners.
• Demonstrate clear and professional verbal and written communication.

Qualifications:

• Ph.D. in Pharmaceutical Sciences or Biochemistry or a related field with at least 5 years of relevant experience OR MS with at least 8-10 years of relevant experience OR a BS with at least 12 years of relevant experience is required.
• Demonstrated competency and experience with biological, vaccine or preferably viral vector formulation and drug product development to enable GMP production.
• Experience developing drug product processes and procedures and transferring of them to cGMP facilities is required.
• Ability to work independently on multiple programs and represent Drug Product at cross- functional teams.
• Effective communication skills, collaborative skills and demonstrated leadership in providing integration of activities and delivering information across groups is required.
• Experience with developing/evaluating new technologies and new platforms to generate new research ideas and initiatives to build intellectual capabilities is preferred.
• Experience with authoring and reviewing regulatory filings (IND, IMPD, BLA, MAA) is preferred.
• Vaccinated against SARS-CoV2 plus booster.

Interius BioTherapeutics is a small community of individuals, building together an organization celebrating an inclusive culture, guided by dignity and respect. Interius is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status or any other basis, protected by law.