Deciphera Pharmaceuticals logo
Deciphera Pharmaceuticals

As a member of ONO Group

Director, Commercial Manufacturing – Process Engineering

Software EngineerSoftware EngineerFull TimeRemoteLeadTeam 201-500Since 2016H1B SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

8 days ago

Salary

$184K - $253K / year

Seniority

Lead

Postgraduate Degree10 yrs expEnglish

Job Description

Director, Commercial Manufacturing – Process Engineering

Deciphera Pharmaceuticals

• Lead day-to-day oversight of commercial manufacturing operations, process engineering activities, and continuous improvement initiatives. • Drive process optimization, troubleshooting, scale-up, PPQ, validation, and lifecycle management activities for commercial products. • Support regulatory CMC strategy, including development and review of Module 3 CTD submissions and health authority responses. • Oversee CDMO/CMO relationships, ensuring strong technical, operational, quality, and regulatory performance across the supply chain. • Partner cross-functionally to support successful product launches, technology transfers, supply chain expansion, and post-approval improvements. • Lead operational improvement initiatives utilizing Lean/Six Sigma methodologies to improve efficiency, reduce costs, and enhance manufacturing performance. • Manage project timelines, deliverables, and budgets while ensuring alignment with overall business and technical operations strategy.

Job Requirements

  • Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutics, Chemistry, or related life sciences discipline.
  • 10+ years of experience in pharmaceutical or biopharmaceutical CMC development, commercialization, and manufacturing.
  • Strong experience managing drug substance and/or drug product manufacturing programs in regulated environments.
  • Demonstrated success working with CDMO/CMO partners and leading cross-functional technical operations initiatives.
  • Deep knowledge of cGMPs, process validation, regulatory CMC requirements, and global drug development processes.
  • Experience authoring and supporting Module 3 CTD submissions through approval and commercialization preferred.
  • Strong leadership, communication, problem-solving, and stakeholder management skills.
  • Ability to travel up to 30% domestically and internationally.

Benefits

  • Competitive salary and annual bonus.
  • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
  • Generous parental leave and family planning benefits.
  • Outstanding culture and opportunities for personal and professional growth.

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