Regional EM Engineering Lead

GSK•King of Prussia, PA

1d•Hybrid

About The Position

The role ensures External Manufacturing delivers products to patients through strong engineering performance at Contract Manufacturing Organization (CMO) sites. Reporting to the External Manufacturing Engineering Lead, the role is integral in delivering new product introduction from R&D (Research and Development), business development deals and existing GSK products through the full range of engineering input; site assessments, capital management, trouble-shooting and multi-site engineering programs. As the role has a focus on Large Molecule Drug Substance activity, strong knowledge of the engineering aspects of this dose form is necessary. This expertise will also carry over to internal GSK sites when support is required.

Requirements

A minimum of a HND (Higher National Diploma) or an associate degree is required, along with relevant experience in engineering disciplines such as Chemical, Mechanical, Electrical, or Automation.
Minimum 10 years’ experience in relevant roles, with a focus on Large Molecule Drug Substance.
Project or program delivery of large capital projects.
Experience with GSC Engineering Policies, Standards and the Project Management Framework.

Nice To Haves

Bachelor’s or Master’s degree in engineering.
Experience in Drug Product Engineering.
Engineering experience in conjugation projects/operations.
Engineering experience in small molecule – primary and secondary, including API (Active Pharmaceutical Ingredient) /high toxicity API manufacture.
Capital project delivery experience at a Large Molecule Drug Substance/Drug Product site.
Experience of the GSC EHS (Environment, Health, and Safety) Standards.
Experience with broader site/central engineering roles covering utilities, compliance and facilities.
Experience working with external manufacturing sites.
Relationship management, with either internal or external individuals/ teams/ companies, potentially across the world.

Responsibilities

Accountability for a portion of the ~150 site External Manufacturing (EM) network, which covers Medicines and Vaccines Large Molecule Drug Substance and Drug Product, Medicine Small Molecule API and secondary, including newer product types such as Antibody Drug Conjugates and Oligonucleotides.
As the Engineering Subject Matter Expert (SME) for Large Molecule Drug Substance, the role also supports internal Large Molecule Drug Substance sites.
Engineering performance accountability (equipment uptime, engineering safety and quality compliance) through engagement including site visits/audits and virtual engagement.
Oversight and accountability for key capital project delivery, enabling new product launch/supply continuity.
Responsibilities as the Large Molecule Drug Substance Engineering Subject Matter Expert.
Programs or actions to support delivery of the External Manufacturing strategic objectives (safety improvements, waste elimination, product cycle time reduction etc.)
Delivery of improvement programs e.g. Extractables & Leachables, PFAS, obsolescence management.
Engineering input into the development of recommendations from the GSC (Global Supply Chain) Strategy team.
Possible ownership of the External Manufacturing capital plan.
Engineering capability building of the External Manufacturing team and the external sites.
Collaborative working with Smart Manufacturing and the Tech team to integrate Engineering activities.