Sr. Scientist, Drug Product Development

Adverum Biotechnologies, Inc. is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.

Note to Recruiters and Agencies

All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team.  Unsolicited resumes sent to Adverum will be considered property of Adverum.   Agencies must be expressly engaged by Adverum’s Talent Acquisition team for any requisition.  Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.

Adverum is looking for a Sr. Scientist, Drug Product Development to report to the Director, Drug Product. This role will involve collaborating with internal and external teams to improve drug product manufacturing processes, including conducting experiments for drug formulation development, stability studies, and establishing scale-down models for process design. The Senior Scientist will also be responsible for developing and scaling up manufacturing processes, supporting technology transfer to CDMOs, and overseeing internal and contract lab activities. The ideal candidate will have extensive experience in biologics or viral vector drug product development and process optimization. Strong problem-solving, communication, and organizational skills are essential in this dynamic and fast-paced environment.

• Demonstrates technical proficiency, scientific creativity, cross-functional collaboration with External Manufacturing, Process Development, Analytical Development, Quality Control, and other relevant stakeholders to drive improvement, consistency and compliance for drug product manufacturing processes.
• Establish internal Drug Product Development capabilities including:
• Design and conduct experiments to develop stable and effective drug formulations, including selection of excipients and compatibility studies.
• Conduct stability studies to assess the short- and long-term integrity of drug products under various storage conditions and identify potential degradation pathways.
• Establish and qualify representative scale down models in support of drug product process design.
• Design drug product process characterization (PC) strategies, engage cross-functional SMEs and execute PC activities to enable BLA submission.
• Develop and scale-up manufacturing processes considering critical process parameters (CPPs) and critical quality attributes (CQAs). Utilize statistical analysis and experimental design to identify and improve process parameters, maximizing product yield and quality consistency.
• Provide support for drug product process technology transfer and GMP manufacturing at CDMOs, review GMP documents, troubleshoot technical issues, support deviation investigation, lead risk assessment and serve as person-in-plant as required.
• Manage, collaborate and provide scientific oversight of formulation and drug product process development and data generated by internal and contract labs.
• Must think critically, ability to work independently and awareness on when to seek guidance and have strong organizational and planning skills.
• Author and review technical development documents including study protocols, technical reports, batch records and DP-related sections in regulatory filings.
• Stay abreast of industry trends, emerging technologies, maintains working knowledge of state-of-the art principles and theories, applying said knowledge that supports Adverum’s interests.
• Provide direction and leadership to junior scientists as the team expands.
• Contributes to the overall strategy, performance, and direction of the Drug Product Development function.

• Ph.D. in Pharmaceutical Chemistry, Biochemistry, Chemistry, Chemical Engineering, Bioengineering or related discipline with 5-8 years of relevant experience in biologics or viral vector drug product development; or M.S. with 8-11 years of relevant experience.
• Must have proven experience with formulation development, drug product process development and optimization, statistical design and analysis of experiment, managing CROs, tech transfer to CDMOs.
• Must have knowledge and hands-on experience with analytical instrumentation used in biologics/viral vector formulation and process development such as spectrometry, HPLC, CE, particle characterization techniques, calorimetry, light scattering etc.
• Experience with fill-finish processes, clinical compatibility studies, scale-up and/or technology transfer.
• Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up.
• Knowledge of regulatory requirements and quality standards related to biopharmaceutical manufacturing.
• Must have excellent problem-solving skills, verbal and written communication skills.
• Ability to work in a dynamic environment, with a willingness to adapt to shifting priorities and tasks.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
• Ability to work independently in a fast-paced startup environment as well as work collaboratively in a highly interactive team environment.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation.