VP, Biologic Manufacturing Development & Strategy

ARTO

Massachusetts

On-site

USD 300,000 - 430,000

Full time

14 days+

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Job summary

ARTO in Massachusetts seeks a Vice President of Manufacturing Development to lead the manufacturing development function for its biologics portfolio and pipeline. The role reports to the CTO and partners across Technical Operations, Quality, Regulatory Affairs, and Supply Chain to drive strategy, lifecycle management, and reliable commercial supply.

The successful candidate will balance strategic leadership with hands-on technical decision-making in a fast-paced biotech environment, guiding

Qualifications

Significant leadership experience within Manufacturing Development, Technical Operations or Biologics Manufacturing.
Strong understanding of cGMP manufacturing and global regulatory expectations.
Experience managing external CDMO relationships and complex manufacturing networks.
Proven experience supporting commercial biologic products and late-stage development programs.

Responsibilities

Lead the Manufacturing Development function across commercial product and pipeline programs.
Develop and execute manufacturing development strategy to support commercial supply and future product launches.
Oversee technology transfer, process validation, process performance monitoring and lifecycle management activities.
Drive manufacturing process optimisation, continuous improvement and operational excellence initiatives.
Provide technical leadership across internal teams and external CDMO partners.
Build, mentor and develop a high-performing Manufacturing Development organisation.
Partner with Manufacturing, MSAT, Regulatory Affairs, Quality and Supply Chain to ensure cross-functional alignment.
Support regulatory inspections, post-approval changes and global manufacturing readiness.
Contribute to the broader Technical Operations strategy as a member of the leadership team