Aurion Biotech logo
Aurion Biotech

We're on a mission to cure blindness with our transformational platform of advanced therapies.

Senior Manager, External Manufacturing Operations

OperationsOperationsFull TimeRemoteSeniorTeam 51-200Since 2022Company SiteLinkedIn

Location

Kentucky + 11 moreAll locations: Kentucky, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Massachusetts, Pennsylvania, South Carolina, South Dakota, Texas, Washington

Posted

1 day ago

Salary

$179K - $202K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglish

Job Description

• Manage operational and technical support of small molecule CDMOs to deliver on late phase clinical and commercial production. • Lead CDMOs to implement CMC strategy in manufacturing including but not limited to efforts to optimize manufacturing processes, implement process changes, and reduce manufacturing costs. • Provide on-site CDMO oversight, as needed, to accomplish clinical and routine, commercial production goals. • Provide SME impact assessments on deviation investigations, support CAPAs, and manage proactive initiatives and change controls, as required. • Lead review and approval for technical reports, risk assessments, batch records, SOP’s, etc. required for cGMP manufacturing. • Develop, track, and monitor production data for CMO during clinical manufacturing and PPQ to mature to continued process verification (CPV) during commercial manufacturing. • Represent External MFG / MSAT on cross functional teams (internal and external) for late stage / commercial CDMO. • Act as the internal project team lead for CDMO. • Ensure operational robustness and efficiency through management and tracking of manufacturing metrics and KPIs. • Support authoring and review of CMC sections of health authority submissions. • Provide immediate response support, as required. • Develop and maintain strong relationships with internal stakeholders and external partners and ensure strong collaboration and productivity to deliver successful late phase, scale-up cGMP clinical and commercial batches.

Job Requirements

  • B.S, M.S, or Ph.D. degree in chemistry, chemical engineering or related, scientific discipline required.
  • 10+ years of experience w/ a B.S.; 7+ years of experience w/ M.S. or higher.
  • 5+ years of experience, in process chemistry/development, MS&T, and/or External Manufacturing for small molecules required.
  • cGMP manufacturing experience required. 3+ years preferred.
  • Experience managing production at CDMOs required. 3+ years preferred.
  • Experience with late-stage clinical enabling, PPQ and commercialization activities for small molecules preferred.

Benefits

  • Robust Benefits : We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
  • Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
  • Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.

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