Manager, Manufacturing-Sterile Filling

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

**The schedule will start out M-F for the initial 9-12 months during project work and transition to a 12 hour (6am-630pm), 2-2-3 schedule rotation (2 on, 2 off, every other weekend)

Position Summary & Responsibilities

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

This position will begin within the MSAT organization, with responsibilities to include setting up the manufacturing process and procedures through the tech transfer stage. The position will be a part of the asset delivery team, ultimately responsible for delivering the entire Fill asset to the Operations team, and then transitioning into the Operations team organization at commercialization of the fill line.

* Provides direction to PET personnel in the efficient use of equipment and materials to producequality products in accordance with regulations and client's requirements.
* Responsible for all PET activity to include coordination of support staff, scheduling andimprovement.
* 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 OperatingProcedures. Partners with PET Coach to develop training plans and assist in providing resources for training.

* Develops the production operating model for the new fill line

* Responsible for hiring a portion of the operations team to be included within the asset delivery team and tech transfer of the new fill line

* Performs aseptic behavior compliance Gemba walks to coach and ensure compliance withaseptic 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.

* Generates reports for deviations, assists in the investigations, and recommends/implementssolutions to resolve deviations. Approves deviation investigations as appropriate. Responds toproduct 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 safetyusing 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 practicesand lean behavior.
* Maintain presence across multiple shifts.
* 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.

Minimum Qualifications
1. Significant experience in GMP or regulated production environment

2. Previous supervisory experience

3. Knowledge of FDA cGMP's

4. Strong communication, coaching and leadership skills

5. Problem solving skills

6. Ability to delegate tasks and projects effectively

Preferred Qualifications
1. Bachelor of Science in Engineering, Pharmacy, related Science or business.
2. Experience working in a LEAN manufacturing environment
3. Working knowledge of LDMS or Veeva, Microsoft applications, SAP.

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

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

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

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

8. Project management skills

9. Experience in Technology Transfer in a GMP environment

10. Ability to generate and interpret technical documents

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.

As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards. Please review the video below, which outlines the most extensive process to gown within specific areas of Sterile Operations at Resilience, West Chester.