Supervisor, Manufacturing-Filling (Nights)

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

Primary Responsibilities

* Provides direction to PET personnel in the efficient use of equipment and materials to produce quality products in accordance with regulations and client's requirements.

* Responsible for all PET 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 SHE standards are met on a daily basis.

* Accountable for training of PET personnel on equipment, processes and Standard Operating Procedures. Partners with PET Coach to develop training plans and assist in providing resources for training.

* Performs aseptic behavior compliance Gemba walks to coach and ensure compliance with aseptic filling. * Ensures that cGMP's and SOPs are used and followed during production of products.

* Promotes a positive work environment by effectively administering Resilience Human Resources policies and procedures including Performance Management and by 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.

* Promotes and encourages continuous improvement in efficiency, quality, production, and safety using team driven processes and key performance indicators and recognition and rewarding high performance.

* Collaborates with OE Engineers & PET Engineers to optimize process performance.

* Participates in the design, selection, installation and qualification of new equipment, facilities, and processes.

* Provide career development and performance management for direct reports.

* Work collaboratively within and across PETs to ensure flow of product, sharing of best practices and lean behavior.

* 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.

Minimum Requirements

* Prior experience in GMP or regulated production environment

* Previous supervisory experience.

* Knowledge of FDA cGMP's.

* Strong communication and leadership skills.

* Problem solving skills.

Preferred Background

* Bachelor of Science in Engineering, Pharmacy, related Science or business.

* Experience working in a LEAN manufacturing environment

* Working knowledge of LDMS or Veeva, Microsoft applications, SAP.

* Training or experience in formulation, filling, packaging, validation, technology transfer, change control.

* Knowledge or previous experience with pharmaceutical manufacturing, aseptic filling preferred.

* Strong mechanical, troubleshooting, and problem-solving abilities.

* Ability to direct and participate in cross-functional teams.

* Project management skills

* Occasionally performs rolls for PET Lead when designated.

* Ability to work effectively in a team environment.

* Candidate should possess the ability to work in a changing/demanding environment and maintain presence across multiple shifts.

Resilience is an Equal Employment Opportunity Employer. Qualified applica