Senior Manager, Device Assembly & Packaging

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 Senior Manager is a leader of a multidisciplinary process execution team to deliver the manufacturing performance in line with the agreed manufacturing plan. They will lead the development and implementation of strategies to improve the overall performance of the Process Execution Team over time and influence the strategic direction for the Process Execution Team. They may act as a representative for the manufacturing function within Resilience on projects and working teams. They have primary responsibility for the personnel, facilities and equipment within a PET operating area. This includes personnel responsibilities across multiple shifts and responsibilities to provide direction to Supervisors within the PET to optimize quality and performance of the operation. They will be responsible for independent decision making for operations within the PET in the absence of or in support of the PET Lead. As a responsible leader, they must maintain effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as EHS obligations and Resilience standards.

Job Responsibilities

• Provide direction to PET personnel in the efficient use of equipment and materials to produce quality products.
• Responsible for all PET activity to include coordination of support staff, scheduling, and improvement initiatives. This coordination may be across shifts and across Supervisors directly reporting to this role. This individual must have the ability to manage large groups (e.g. 80 or more people) and meet performance management goals.
• Mentor and coach Supervisors on individual and team development.
• Provide assistance to the PET Lead during the PET budgeting process and provides financial analysis as requested by the PET Lead.
• Promote 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 to ensure adequate level of training for PET personnel on equipment, processes, EHS, and Standard Operating Procedures. Partner with PET Process Lead to develop training plans and assist in providing resources for training.
• Ensure that cGMP's are used and followed during production of products so that all FDA and international regulations are met.
• Ensures timely responses to internal and external audit observations.
• Promote 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.
• Ensure proper documentation practices are maintained consistently to company standards in manufacturing documents and training documentation. Ensures PET reports for deviations and recommended/implemented solutions to resolve deviations are completed in a timely fashion. Approves deviation investigations and responds to product defect notifications as appropriate.

• Promote and encourage continuous improvement in efficiency, quality, product delivery, and safety through the use of team driven processes, key performance indicators, and recognition and rewarding for high performance.
• Collaborate with MSAT Engineers & PET Engineers to optimize process performance.
• Participate in the design, selection, installation, and qualification of new equipment, facilities, and processes.
• Provide career development and performance management for direct reports.
• Co-own life cycle management of PET/facility assets
• Work collaboratively within and across PETs to ensure flow of product, sharing of best practices, and lean behaviors.
• Perform roles for PET Lead when designated.

Required Qualifications:

• Experience in GMP or regulated environment.
• Experience with Regulatory Authorities and communication during audits.
• Direct supervisory experience.
• Knowledge of FDA cGMP's.
• Strong communication and leadership skills.
• Problem solving skills.

Preferred Qualifications:

• Minimum 8 years' experience in GMP or regulated environment.
• Minimum of 5 years supervisory experience.

• Bachelor of Science in Administration, Business, Engineering, Pharmacy, or related Science.
• Experience working in a LEAN manufacturing environment.
• Working knowledge of Microsoft applications, SAP and Veeva.
• Training or experience in formulation, filling, packing, validation, and technology transfer, Knowledge or previous experience in managing technical programs/projects.

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.