Manager, Technical Services

Job Description

Oversee design, optimization and implementation of site manufacturing processes to improve efficiency, quality and sustainability
Lead team to establish and track process metrics to monitor process stability and discover areas for improvement
Oversee Technical Transfer of new products from both internal and external clients
Drive team ownership of product processes from initial quote to product retirement
Evaluate incoming processes for robustness, efficiency and fit within JHS-Spokane
Lead team to perform appropriate development work to define CPPs and CQAs to allow strong execution upon transfer to Manufacturing
Review and approve validation study documents that demonstrate manufacturing processes are capable of consistently making acceptable product
Oversee development and execution of validation studies to test and qualify new and improved manufacturing processes
Lead team through troubleshooting, oversight and/or sampling of events within Manufacturing; will require occasional off-shift at-location or remote support
Review and approve reports summarizing results of studies to document data collected; overview utilization of data obtained to qualify site processes
Review and approve protocols, SOPs, reports, deviations and other documents requiring Technical Services approval
Oversee team review of data summaries generated by other departments, assessment of the data for potential trends or conditions that may adversely impact the quality of the sterile products being manufactured, and ensure that corrective action measures are implemented when required/warranted
Optimize gross profit margin and minimize deviation rate
Provide necessary reviews for regulatory and client audits and provide responses to audit observations
In-depth understanding of cGMP’s, European regulatory requirements, relevant USP chapters, and scientific principles associated with clean room operations and room classifications as they apply to media fills, sterilization and depyrogenation (dry heat and steam), endotoxin reduction, and microbiological monitoring and control.

Qualifications

• A Bachelor’s of Arts or Science with a major in Biology, Chemistry, Physics, or Engineering is required.
• 7-10 years related Pharmaceutical experience or FDA regulated Industry Experience
• Supervisory or other Leadership Experience
• Project Management
• Advanced vocational/specialized knowledge Microsoft Office

Benefits

• Hiring Wage: $118,500 – 189,600 annually + 10% bonus / 7.5% shift differential, with opportunities for growth, promotion, and annual raises.
• Starting on your first day, you receive: Medical, Dental & Vision coverage, Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA), Life & AD&D Insurance, Short-Term & Long-Term Disability Insurance, Employee Assistance Program.