50 applicants

Company

Original Job Post

Adverum Biotechnologies · 2 days ago

Associate Director/Director, Drug Product

Redwood City, CA

Full-time

Onsite

Director

$182K/yr - $240K/yr

7+ years exp

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BiotechnologyPharmaceutical

H1B Sponsorship

Comp. & Benefits

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Responsibilities

Provide overall leadership and vision to the Drug Product PD team. Organize and develop an efficient group for diverse unit operations and analytics.

Ensure the team is properly staffed, structured, and resourced for success.

Collaborate with various departments to understand customer requirements, develop support plans, and execute them.

Build and optimize a Drug Product PD lab with appropriate models and analytics.

Lead late-stage development activities, support DP PPQ-related activities, and implement new technologies for AAV manufacturing processes.

Define and support various DS/DP stability studies, provide input on CMC sections of regulatory submissions, and represent the organization to stakeholders.

Mentor and support a high-performance team, serve as a subject matter expert, and contribute to a strong company culture.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Protein-based therapeuticsVaccinesAAV productsIndustrial process developmentDevice formulation developmentCQAFMEAProcess characterizationGMPTechnology transferProblem-solvingLeadershipCommunicationTeamworkMentoring

Required

Ph.D. in Formulation Science, Biochemistry, Chemical Engineering, Biological Engineering, or appropriate technical discipline with 7+ yrs of relevant industrial experience (M.S./B.S. in corresponding fields with 12+ yrs)

Prior experience and expertise working on the drug product development of protein-based therapeutics and/or vaccines. Prior experience working on the drug product development of AAV products is key

Prior experience working in an industrial process development and/or device and formulation development environment

Prior experience managing and leading said group(s). Prior experience managing a formulation or drug product team is a plus

Prior experience with CQA and FMEA exercises. Prior experience with late-stage process characterization activities is a plus

At least 4 years of management experience

Strong background experience working with and/or in a DP fill, GMP operating environment, and prior experience with technology transfer activities

Ability to build strong but flexible organizational structures and systems

Ability to effectively manage down to their teams, out to their peers and up to the leadership

Requires excellent written and oral communication capabilities

Desire to build synergistic and collaborative teams emphasizing building and supporting a strong company culture

Desire to mentor and develop members of their team

Benefits

Medical

Dental

Vision

401k

STD/LTD

Life and accident insurance

Either paid time off or flexible paid time off

Company

Adverum Biotechnologies

Adverum Biotechnologies is a gene therapy company that focuses on developing medicines that can offer therapeutic benefits to patients.

Founded in 2006

Menlo Park, California, USA

51-200 employees

http://adverum.com/

H1B Sponsorship

Adverum Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2022 (1)

2021 (1)

2020 (3)