Manager/Sr Manager External Manufacturing
Adverum is looking for a Sr. Manager / Manager, External Manufacturing to join our team in our Redwood City office. This position reports into the Sr. Director, External Manufacturing. The Sr. Manager / Manager, External Manufacturing, will be responsible for managing operations at Adverum’s contract manufacturing organization(s)s (CMO) and activities related to the GMP production of early and late phase clinical materials. This role is primarily focused on CMO(s) for AAV/gene therapy drug substance manufacturing. As programs advance, the role will may also be responsible for managing commercial supply at CMO(s). This role interacts with cross functional team members from internal quality, supply chain, process experts, regulatory affairs, and finance in order to provide oversight and coordination of CMO related activities.
What you'll do:
- Manage and oversee cGMP operations at Adverum’s drug substance CMO to ensure manufacture of Adverum products on-time and meeting quality, compliance, and applicable regulatory requirements.
- Lead and facilitate the meetings between the CMO and internal team members.
- Ability to build trust and positive working relationships as Person-in-Plant at the CMO(s).
- Build and maintain collaborative working relationships with internal stakeholders (QA, QC, Process Science, SCM, etc.)
- Review executed batch records and accompanying batch release documentation for accuracy and compliance.
- Possess a thorough knowledge of Quality Management Systems. Ensure timely closure of deviations, investigations, CAPAs, and change controls at CMO.
- Establish and ensure adherence to MSAs, SOWs, and other manufacturing agreements. Track CMO related activities and deliverables relative to budget and Company objectives.
- Effectively communicate changes and resolve issues with CMOs.
- Proactively develop, manage, track, and improve CMO performance. Set milestones and monitor KPIs. Report out CMO Manufacturing updates.
- Lead and/or participate in cross functional manufacturing projects to ensure Adverum objectives.
- Responsible for the timely execution of Technology Transfer plans to CMO in preparation for clinical trials and commercialization.
About you:
- Bachelor's degree in a scientific discipline with 5+ years of experience in the biotech/pharmaceutical industry.
- Experience in clinical development stage projects required with additional experience in commercial manufacturing and supply chain management a plus.
- cGMP Cell Culture or Purification experience required. Prior work experience with AAV/gene therapy highly desired.
- Proven track record of managing CMO GMP production operations and budgets.
- Proven ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders.
- Knowledge of cGMP Quality Systems including change control, discrepancy management, CAPA, lot release and validation.
- Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.
- Project management experience
- Excellent written and oral communication skills
- Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables.
- Energetic, flexible, collaborative and proactive leader.
- Ability to gown into and work in clean rooms.
- Up to 20% travel, both domestic and international.
About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.
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