Manager, Sterile Man Op

Jubilant HollisterStier LLC, Spokane's Largest Manufacturing Company, and well-established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant HollisterStier is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.

Our Promise: Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

Job Description:

The Manager of Sterile Manufacturing Operations is responsible for leading and overseeing the sterile production processes. This role ensures that sterile formulation and parenteral filling operations are executed in compliance with cGMP, regulatory, and safety standards. The Manager will oversee two Supervisors, one for Sterile Formulation and one for Sterile Parenteral Filling, each leading teams of technicians coordinated by area Specialists. The Manager will drive operational excellence, ensure product quality, and foster a culture of continuous improvement and accountability.

1. Leadership & Team Management

• Provide strategic and day-to-day leadership and development of Supervisors overseeing Mite growth / Pollen cleaning and pre-vaperatoin / pre-filtration processing.
• Foster a culture of accountability, continuous improvement, and collaboration across teams.
• Ensure effective communication, coordination, and collaboration across shifts and departments.
• Mentor and develop Supervisors and Specialists to build a high-performing, engaged, and compliant workforce.
• Support staffing, training, cross-training, succession management and performance management of the RM manufacturing teams.

1. Operational Oversight

• Oversee Scheduling, execution, and documentation of all raw material processing activities.
• Ensure timely and compliant execution of production schedules for raw material processing.
• Monitor and optimize workflows for mite cultivation, pollen cleaning, and pre-processing activities to improve efficiency, reduce waste, and maintain high product quality.
• Oversee adherence to batch records, SOPs, and processing techniques.
• Collaborate with Planning, Quality, Maintenance, Engineering, and Validation teams to ensure seamless operations.

1. Compliance & Quality Assurance

• Maintain strict compliance with FDA, EU, and other applicable regulatory requirements.
• Lead and support internal and external audits, including CAPA implementation and follow-up.
• Collaborate with Quality Assurance and Manufacturing Compliance to address deviations, CAPAs and audit findings.
• Ensure proper documentation practices and data integrity across all operations.

1. Continuous Improvement & Efficiency

• Identify and implement process improvements to enhance throughput, reduce waste, and improve product consistency including automation opportunities, and lean manufacturing initiatives.
• Utilize data driven approaches to analyze production data and KPIs to monitor operational metrics, drive performance improvements and root cause investigations.
• Foster a culture of safety, quality, and continuous improvement.

1. Technical & Cross-Functional Collaboration

• Serve as a subject matter expert (SME) for raw material processing processes and equipment.
• Partner with Supply Chain, Quality, Engineering, and R&D to ensure seamless integration of upstream and downstream processes.
• Partner with Quality Assurance, Validation, and Engineering to support tech transfers, equipment qualification, and process validation.
• Support new product introductions and scale-up activities.

1. Safety & Training

• Promote a safe working environment and ensure compliance with EH&S policies.
• Oversee training programs for new hires and ongoing competency development for existing staff.

1. Key Performance Indicators (KPIs):

• On-time completion of raw material processing batches as per production schedule.
• Compliance rate with cGMP and internal quality standards.
• Reduction in processing deviations and non-conformances.
• Efficiency improvements in mite growth, pollen cleaning, and pre-processing workflows.
• Employee training completion and competency rates.
• Team performance and engagement scores.
• Successful implementation of process improvement initiatives.
• Audit readiness and outcomes from internal and external inspections.
• Inventory accuracy and raw material utilization efficiency.

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, or related field required
• 5+ years of experience in sterile pharmaceutical manufacturing, with at least 3 years in a leadership role required
• Strong knowledge of aseptic processing, cGMP, and compliance required
• Proven ability to lead teams in a fast-paced, regulated environment required
• Excellent communication, organizational, and problem-solving skills required
• 5 to 10 year(s) related experience in lieu of degree preferred
• Supervisory Experience desired
• Managerial Experience desired
• Pharmaceutical Experience desired
• Experience in SAP required
• Experience in Office (Word, PowerPoint, Excel) required
• Ability to work independently required
• Exospore to Allergens and working in Aseptic areas required

Shift: Weekday Days, Monday- Friday

Compensation & Benefits:

This is an on-site, full-time position located in Spokane, WA.

• Hiring Wage: $80,500 - $146,700 annually depending on experience, with opportunity for growth, promotion and annual raises. Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role

• This position is eligible for a shift premium of $2.00 per hour worked between 3pm and 11pm, and $2.50 per hour worked between 11pm and 7:30am.
• This position is eligible for an aseptic premium of $2.00 per hour worked in qualifying aseptic areas.

• Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
• Life, AD&D, Short and Long Term Disability
• 401(k) with company match
• Generous paid time off plan
• Employee Assistance Program

Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!

https://jubilantcareer.jubl.com/

*Please click on the Spokane, Wa. Link*

Jubilant HollisterStier is an EEO/AA Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If you require assistance applying for a position, please contact our HR Department at:

JHS-TalentAcquisition@jubl.com