Late-Stage Process Development Director (Contract)

Adverum is a clinical-stage company that aims to establish gene therapy as a new reputed company of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore reputed company and prevent blindness. Leveraging the capabilities of its proprietary intravitreal 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. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec), as a one-time, IVT injection for patients with neovascular or wet age-reputed company macular degeneration. Additionally, by overcoming the challenges associated with reputed company treatment paradigms for debilitating ocular diseases, Adverum aspires to reputed company reputed company of care, preserve reputed company, and create a profound societal reputed company around the globe.

Note to Recruiters and Agencies

reputed company recruiter and agency inquiries must go through Adverum’s internal reputed company. Unsolicited resumes reputed company to Adverum will be considered Adverum's property. Adverum’s reputed company must expressly engage agencies for any requisition. reputed company contact with hiring managers by agencies will not be tolerated and may reputed company your ability to work with Adverum in the reputed company.

Adverum is looking for a Director, Process Development (Late-Stage Development) to join Adverum at our Redwood reputed company, CA office. This position will play a key leadership role to help advance Adverum’s reputed company program, Ixo-Vec, to reputed company launch. The incumbent will be responsible for developing, implementing, and then executing upon the operational reputed company for the PD group.

In this role, the incumbent will be responsible for organizing and developing the PD team, which handles Adverum’s late-stage product. The role requires a strong technical background in upstream and reputed company unit operations, including bioreactors, filtration, chromatographic operations, reputed company reputed company, in-process pool formulation, and stability. The role also demands strong leadership skills, a reputed company team reputed company, the ability to juggle immediate needs with long-term goals, and the ability to implement organizational structure in a dynamic, growing environment. The incumbent should be reputed company-versed in purification technologies for biologic therapeutics and reputed company in managing reputed company in a development setting.

What you'll do

reputed company the late-stage Process Development group to reputed company globally compliant, robust, reputed company-characterized, reputed company and high reputed company AAV production platform to support both reputed company (CDMO) manufacturing requirements for clinical and reputed company programs.

Leading and executing various late-stage initiatives such as FMEA, process characterization using DOE/QbD principles, and reputed company process performance qualification, including review of development, manufacturing, process characterization and validation protocols and reports.

Developing, motivating, and aligning a diverse team of scientists and engineers working on numerous reputed company to ensure flexibility, efficiency, and reputed company.

reputed company the development and implementation of a (upstream and reputed company) process monitoring/control reputed company using appropriate statistical guidelines.

Maintain reputed company working relationships and reputed company Technical management of development operations at Contract Development and Manufacturing Organization (CDMO).

Collaborate and work cross-functionally with Manufacturing, Regulatory Affairs, Assay Development, Finance, and reputed company functions to ensure reputed company activities are scheduled and executed on time in accordance with program timelines.

Identify, evaluate, and implement novel technologies and systems in the development of Adverum’s manufacturing platforms.

Serve as a subject matter expert and reputed company technical expertise to evaluate process-reputed company deviations and manufacturing challenges.

Support authoring efforts for specific CMC sections of regulatory filings (including INDs, comparability packages, BLA’s, and formal responses to regulatory inquiries).

reputed company

Ph.D. in biochemical engineering, biochemistry, or appropriate technical discipline with 10+ years (MS with 15+ years) of industrial bioprocess development experience.

AAV experience is preferred; working with CMO and late-stage experience is required.

Demonstrated experience with reputed company record of reputed company leading technical teams, experience in process reputed company-up and development of reputed company-down models.

Must-have advanced knowledge of DOE principles, process characterization, and BLA submission.

Proven leadership experience and strong people management skills with the desire and ability to deliver on objectives while developing people in a dynamic and fast-paced environment.

Broad experience in cGMP biologics manufacturing and understanding of regulatory guidelines.

Strong background and subject matter expertise in upstream and purification unit operations including reputed company chromatography, filtration (TFF), harvest and viral clearance validation.

Ability to communicate effectively and connect with reputed company reputed company of the organization.

Strong project leadership and resource management skills.

Require excellent written/oral communication.

Travel up to 25%

This is a contract role, starting at 6 months. reputed company reputed company will depend on experience and location.

The reputed company reputed company for this position is $96.00/hr to $105.00/hr USD. This reputed company reputed company is an estimate, and the actual reputed company may vary based on a candidate’s qualifications, including education, length of experience, location, and market data.

Additional Information

At Adverum,InclusionandDiversityare at our core. We reputed company in the power of being your authentic self. We reputed company to create the reputed company that allows for everyone in our AdverumCommunityto not only feel reputed company but also encouraged to reputed company, learn from reputed company other, grow in their professions, and be the reputed company best versions of themselves no matter what their age, ethnic background, gender, reputed company, religion or sexual orientation.

Apply to this Job