Engineering Group Leader

Job Description

Position Summary:

Combining leadership and technical excellence, the Process Engineering Group Leader leads a team of engineers responsible for the manufacture of active pharmaceutical ingredients. The team oversees multi-step, multi-year programs that define the cGMP manufacturing process for active pharmaceutical ingredients. The Group Leader manages resources, sets annual goals for the team, provides coaching, builds development plans, and is responsible for recruiting, onboarding, and training team members. They are also an engineering expert, interfacing with internal leadership and external clients to solve complex technical problems and ensure high-quality manufacturing.

Accountabilities and Responsibilities:

• Lead a team of 4-7 engineers as direct reports, managing resources effectively and determining project assignments.
• Develop team members through technical oversight, mentoring, coordination of training, and performance management.
• Provide technical guidance or direct support for the conceptual process design for complete API programs including: scaling calculations for unit operations, equipment selection, production planning, and determination of operating parameters.
• Guide the team through process reviews for operability, safety, and quality; complex quality investigations and corrective action / preventative action implementation; and the initiation of improvements through ideation, process modelling and the analysis of production and laboratory data.
• Operate as a subject-matter expert for external clients and internal stakeholders.
• Identify, oversee, and conduct process improvement projects to reduce cycle time, increase yield, and improve quality.
• Coordinate the drafting of manufacturing documents: process flow diagrams, batch records, validation protocols, standard operating procedures, quality investigations, campaign reports.
• Partner with engineering technical and department leadership to define engineering best practices and implement them consistently across the department and to drive continuous improvement in the CCC processes and systems to become ‘best-in-class.’

Requirements:

B.S. degree in Chemical Engineering or related field.
7-15 years of experience in chemical development, chemical manufacturing, chemical engineering design, or the equivalent.
2+ years of supervisory/management experience is preferred.
Experience in a chemical manufacturing environment, particularly pharmaceutical, is preferred.