Manager, Manufacturing

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Brief Job Description

The Manager Sterile Filling Operations is a leader for the Process Operation. In this capacity, the Manager manages the Process Operation to produce high quality product in accordance with the operating strategy. As a responsible leader for the operation (potentially with other Supervisors), this must be done while maintaining effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as EHS obligations and Resilience standards.

Job Responsibilities

• Provides direction to personnel in the efficient use of equipment and materials to produce quality products in accordance with the Operations Plan.
• Responsible for all Operations activity to include coordination of support staff, scheduling and improvement.
• Promotes the use of safe work practices during all aspects of production and ensures all external and Resilience EHS standards are met on a daily basis.
• Accountable for training of personnel on equipment, processes and Standard Operating Procedures.
• Ensures that cGMP's are used and followed during production of products so that all FDA and international regulations are met. Responds to internal audit observations.
• Promotes a positive work environment and communicating information to employees and responding to their concerns.
• Ensures proper documentation practices are maintained consistently to company standards in manufacturing documents, training documentation, production logs, etc.
• Generates reports for deviations, assists in the investigations, and recommends/implements solutions to resolve deviations. Approves deviation investigations as appropriate. Responds to product defect notifications.
• Authors, reviews, and approves Standard Operating Procedures and other documents to ensure integration of cGMPs and improve process efficiencies.
• Promotes and encourages continuous improvement in efficiency, quality, production, and safety through the use of team driven processes and key performance indicators and recognition and rewarding high performance.
• Collaborates with Technical Teams to optimize process performance.
• Participates in the design, selection, installation and qualification of new equipment, facilities, and processes.
• Reviews, approves, and implements change control.
• Provides career development and performance management for direct reports.
• Co-owns life cycle management of PET/facility assets
• Works collaboratively within and across PETs to ensure flow of product, sharing of best practices, and lean behaviors.

Minimum Qualifications:

• Experience in GMP or regulated production environment
• Previous supervisory experience Food or Pharmaceutical manufacturing.
• Experience working in a LEAN manufacturing environment.
• Knowledge of FDA cGMP's.
• Strong communication and leadership skills.
• Problem solving skills.

Preferred Qualifications:

• Bachelor of Science in Engineering, Pharmacy, related Science or business.
• Working knowledge of LDMS or Microsoft applications, SAP, Veeva.
• Training or experience in formulation, filling, packaging, validation, technology transfer, change control.
• Knowledge or previous experience in managing technical programs/projects.
• Strong troubleshooting and problem-solving abilities.
• Ability to direct and participate in cross-functional teams.

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Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.