Scale mAbs Engineering Project Head Job Allentown area,Pennsylvania USA,Engineering

Large Scale mAbs Engineering Project Head

Main Responsibilities:

Lead the Large Scale mAbs project and coordinate setup of a new drug substance manufacturing building.
Perform early enabling works, permitting, and constructability reviews; drive the project through BOD, DD, Construction, Commissioning & Qualification, and Handover.
Provide overall leadership and direction to the project team; ensure facility/equipment are designed, installed qualified, maintained, and that processes are properly validated.
Ensure Safety & Quality standards and regulatory commitments are met.
Oversee Engineering, Automation, Maintenance, and C&Q activities.
Ensure on-time/on-budget execution.
Identify, track, and report project risks; implement mitigation plans.
Ensure the delivered building meets SPE performance targets.
Build and execute manufacturing staffing and training plans; support workforce planning.
Support integration of the new facility within a legacy brownfield site.
Provide manufacturing schedule for execution and ramp-up to routine operations.
Partner with MSAT on optimal process definition for new equipment/facility to ensure robustness, product quality, and cost optimization.
Own Cap Ex management and COGs optimization.

About You (Qualifications/Skills):

Degree in Life Sciences, Engineering, or Biotechnology.
10+ years project management experience, including projects >€1B.
10+ years managing large teams (+100 people).
10+ years broad pharmaceutical/pharma industrial experience.
Experience with multi-site operations, global projects, and matrix management.
Thorough knowledge of cGMP and regulatory requirements.
Proven ability to build high-performing teams; decisive in complex, fast-paced environments.
Intercultural experience; excellent communication skills.
Ability to influence and build strong relationships with internal/external partners.

Benefits (if part of the job description):

Health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.