Manager, Process Development

LGC Group•Middleton, WI

5d•Onsite

About The Position

The Manager, Process Development is a key technical expert and business partner dedicated to delivering product and/or service offerings at a specific operational site. They offer technical expertise and daily leadership to business staff who craft manufacturing processes, investigate technical product complaints, and complete co-development work closely with designated customers. The Manager plans, directs, manages, and coordinates group personnel and operational resources involved in the designated responsibilities of this function. In collaboration with HR, functional leadership, and cross-functional partners, this individual is encouraged to promote a positive work environment and a culture of accountability and operational excellence. To perform this job successfully, an individual must be able to capably perform each of the following essential duties:

Requirements

Bachelor’s degree in relevant life sciences field (molecular biology, microbiology, biochemistry, etc.)—or equivalent combination of applicable education and relevant work experience
Progressive experience in a process development or technical operations role within a life sciences organization (pharma, biotech, medical device)
Experience with standard biological and analytical techniques, including PCR, SDS-PAGE, and western blotting
Prior experience with manual or automated chromatography systems or processes (e.g., AKTA platform)
Proven ability to effectively manage a technical team and provide technical mentorship on complex initiatives to achieve project and business goals
Demonstrated track record to lead, manage, and motivate team members through direct line management or influence
Evidential knowledge and experience in risk management and change management
Demonstrated experience in developing and applying new technologies and technical processes that enhance the quality, efficiency, and/or productivity of products
Demonstrated understanding of Lean manufacturing concepts
Strong computer skills required, including working knowledge of Microsoft Office suite of products, particularly Word, Excel, PowerPoint, and Visio

Nice To Haves

Proven knowledge of protein purification and cell banks, preferably enzymes
Experience and proficiency with NGS techniques

Responsibilities

Provide overall leadership to respective team in the areas of safety, efficiency, quality control, cost, equipment, and engagement to support the organization’s commercial and operational activities
Diligently manage the personnel activities of direct and indirect reports. This includes staffing, training, performance evaluations, development, mentoring, coaching, and goal setting. Set employee objectives that align with business initiatives and other important measures.
Ensure personnel resources are adequately directed and aligned to complete business activities in a manner consistent with the site’s quality and customer requirements
Work alongside site leads to develop and apply initiatives that improve product yields, quality, equipment operation, and process control while lowering waste
Regularly seek and support new approaches and practices to improve the efficiency of the direct team and business processes. Lead operational excellence (OE) and on-site efficiency efforts where directed.
Set, standardize, monitor, analyze, and report on key operational metrics, including variances and trends, for team(s) and site(s) under direct remit
Partner effectively with site leads and cross-functional collaborators to ensure daily business objectives are met, including timely response to customer demands
Provide leadership and process for technical product investigations, both internal and external-facing
Coordinate multiple, concurrent product development projects to deliver products on schedule, on spec, and on budget. Prioritize tasks to meet timetables and cost projections.
Actively support and adhere to the requirements of the site quality management system
Adhere to company Personal Protection Equipment (PPE) policy
Perform other duties as required, or assigned by management, to meet business needs