Manager/Sr Manager External Manufacturing
Redwood City, CA
Technology Development – Manufacturing & Supply Chain /
Full Time /
Hybrid
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.
$150,000 - $170,000 a year
The salary range for this position is $150,000 USD to $170,000 USD annually, with the opportunity to earn an annual bonus. This salary range is an estimate, and the actual salary may vary based on a candidate’s qualifications, including education, length of experience, location, and market data. Employees in this position are eligible to participate in the applicable Company equity incentive award plan. The amount of incentive varies and is subject to the terms and conditions of the plan. Employees in this position are eligible to participate in the Company’s standard employee benefit programs, which currently include the following: medical, dental, vision, 401k, STD/LTD, life and accident insurance, and either paid time off or flexible paid time off.
