Key skills
SAPTime ManagementCollaboration
About this role
Role Overview
- guide the successful logistical support for quality records for clinical and commercial manufacturing operations
- supervise a team of technical subject matter experts in biologics operations
- guide investigations, demonstrate strong technical and problem-solving skills, and excellent technical writing skills
- support team in tracking to deviation closure deliverables to meet lot disposition timelines
- improve the technical capabilities and quality practices within the department
- coordinate activities and resolve issues across the department, other groups, and/or projects
- ensure response to and/or resolve recurring technical or processing issues
- drive safety, quality and accountability culture
- communicate information effectively through updates, reports, and summaries
- lead improvements in processes and methods that reinforce cGMP within the department and/or across the site
- participate directly in internal, external, and global health authority audits/inspections
- establish goals of the department
- provide routine updates on progress, status, and issues associated with campaigns/projects
- provide support and/or direction to junior staff when necessary
- exercise sound judgment when making decisions
- make critical decisions in collaboration with key stakeholders
- demonstrate accountability for personal, departmental, and organizational initiatives
Requirements
- BA / BS in a science or engineering related discipline
- minimum 10 years of experience in a GMP manufacturing environment
- minimum 4 years of hands-on experience in fermentation, purification or pharmaceutical manufacturing process
- minimum 4 years of managerial experience guiding teams in a GMP environment
- proven knowledge of cGMP requirements to ensure compliance
- experienced in handling major/critical deviations and leading complex investigations
- strong focus on quality and attention to detail
- effective task/time management organizational skills
- capacity to develop solutions to technical issues of moderate scope
- ability to organize, analyze/interpret, and effectively communicate data and results
- motivated, self-starter with strong mechanical aptitude
- strong proficiency in Microsoft Word, Excel, PowerPoint
- familiar with other enterprise systems such as DeltaV, MES, and SAP
Benefits
- discretionary annual bonus
- comprehensive benefits to include Medical, Dental and Vision
- short-term and long-term disability
- company paid basic life insurance
- 401k company match
- flexible work
- generous paid time off and paid holiday
- wellness and transportation benefits