Job Description
The Manager of Technical Services provides oversight and expertise primarily in the areas of pharmaceutical process engineering and technical transfer. This position will manage large scale projects and multi‑disciplinary teams. The Manager will also provide technical direction for complex projects and exhibit superior communication skills with all levels of employees. The individual will be responsible for refining department and site processes and for providing leadership and guidance to others. Process Engineers will report directly to the Technical Services manager.
Responsibilities
- Oversee design, optimization and implementation of site manufacturing processes to improve efficiency, quality and sustainability
- Oversee and assess existing processes and workflows
- 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; occasional off‑shift at‑location or remote support required
- Review and approve reports summarizing results of studies to document data collected and to assess data for potential trends or conditions that may adversely impact quality
- Review and approve protocols, SOPs, reports, deviations and other documents requiring Technical Services approval
- Oversee team review of data summaries generated by other departments and ensure corrective action measures are implemented when required
- Oversee and participate in deviation investigation and evaluation of impact
- Ensure team implements effective CAPAs
- Optimize gross profit margin and minimize deviation rate
- Provide necessary reviews for regulatory and client audits and respond to audit observations
- Maintain in‑depth understanding of cGMPs, European regulatory requirements, relevant USP chapters, and scientific principles associated with cleanroom operations, media fills, sterilization, depyrogenation, endotoxin reduction, and microbiological monitoring and control
- Perform all supervisory duties for exempt level Process Engineers: assign daily work, hiring, performance management, training and other managerial duties
- Write and manage department SOPs, training, etc. to ensure regulatory compliance and operations enhancement
- Perform job functions autonomously and effectively
- Serve as an authority on technical aspects of site processes and provide leadership and guidance to others on these topics while updating and improving site practices and policies accordingly
- Minimal travel (<15%)
Qualifications
Required:
- A Bachelor’s of Arts or Science with a major in Biology, Chemistry, Physics, or Engineering
- 7-10 years related pharmaceutical experience or FDA regulated industry experience
- Supervisory or other leadership experience
- Project management experience
- Advanced vocational/specialized knowledge
- Microsoft Office proficiency
Preferred:
- Master’s Degree
- Statistical analysis experience
- Lean manufacturing principles
Working Environment
- Prolonged sitting/standing
- Exposure to allergens
- Working in aseptic areas
- Minimal travel (<15%)
Location
Spokane, WA – On Site, Full‑Time
Shift
Weekend Day Shift
Compensation & Benefits
Hiring wage: $118,500 – $189,600 annually + 10% bonus / 7.5% shift differential, with opportunities for growth, promotion, and annual raises.
Benefits start on day one: 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.
EEO Statement
Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
For assistance applying for a position, contact: JHS‑TalentAcquisition@jubl.com