Senior Manager, Manufacturing at Resilience

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

Position Summary

This role is responsible for leading Drug Substance and Drug Product manufacturing operations of cGMP and/or BSL-2/3 products and technologies, including upstream and downstream methods related to large-scale cell culture isolation to support purification and therapeutic, protein, vaccine, virus, and other Medical Counter Measure (MCM) products including cell, virus banking, fill and finish. This leader is responsible for supporting the technology transfer of early and advanced development projects to manufacturing.This role includes ensuring production schedules are met, maintaining high-quality standards, optimizing production processes, managing staff, and ensuring compliance with Safety and GMP regulations. The Sr. Manufacturing Manager reports to the Sr. Director of Manufacturing.

Job Responsibilities

• This position will perform and lead production-related activities in the cGMP Manufacturing Core.
• Ensure all manufacturing operations are executed in strict compliance with Good Manufacturing Practices (cGMPs) regulations and client specifications.
• Lead the designated manufacturing team for a 24/7 operation for upstream/ downstream related activities including cell culture at small and large scale, cell transfection, media and buffer preparation, fermenter-based production, incubation, wave reactors, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, centrifugation, and ultracentrifugation single-use mixers, in-process testing equipment, viral clearance, fill and finish.
• Establishes performance standards and goals for the manufacturing team.
• Oversee development and maintenance of management processes including, but not limited to: Employee job descriptions, KPI’s, staffing models, resource allocation models.
• Conduct regular audits and inspections to ensure adherence to GMP requirements and promptly address any deviations or non-compliance issues.
• Effectively delegate decision-making to the department. Empower direct reports to make level-appropriate decisions.
• Review Procedures, Change Controls, Deviations, CAPAs, EM Quarterly Reports and similar documentation.
• Build strong relationships with key stakeholders across all departments to ensure effective collaboration.
• Utilize lean manufacturing principles and other continuous improvement methodologies.
• Works with subject matter experts to troubleshoot and/or optimize processes as required.
• Supports the technical transfer of new products into the manufacturing area.
• Supports Validation, Engineering, and Facilities personnel in start-up, testing, and operation of manufacturing process equipment.
• Supports audits and regulatory inspections.
• Supports client visits and audits, ensuring that facilities and processes are presented professionally.
• Provide manufacturing area tours to clients, corporate visitors, regulatory agency representatives, and visitors in general.
• Conduct mid-year and end-of-year employee reviews for direct reports.
• Provide other assistance as needed to upper Management.

Minimum Qualifications:

• Experience in leading teams in a Biopharmaceutical Manufacturing environment with increasing responsibility.
• Knowledge of Operational Excellence Experience in change management
• Ability to lead teams to high performance, including performance management, coaching, implementation of development tools, and effective succession and progression planning.
• Experience in providing Manufacturing leadership during internal, client, and regulatory audits and inspections.
• Strong planning and tracking skills, well-organized, focused on results, excellent time management with respect to priorities and self-management.
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.
• Ability to work in a team environment, create timelines and continually make necessary adjustments.
• Excellent problem-solving and analytical skills, with a proactive approach to identifying and resolving operational issues.
• Experience in troubleshooting and root cause analysis.
• Strong communication skills, both verbal and written, with the ability to effectively collaborate with cross-functional teams and stakeholders.
• Ensures the proper processes are in place for GMP and Safety training of staff, with a focus on cross- training and continuously improves production records.
• Knowledge of cGMP's, regulatory guidelines, validation practices, and other relevant regulatory requirements.
• Experience in Drug Substance and Drug Product manufacturing.
• Ability to document work clearly and accurately and be detail oriented.
• Excellent computer skills and MS Office (Word, Excel, PowerPoint, Project, etc.)

Preferred Qualifications

• Possess a B.S. (Engineering, Biology, Microbiology, Chemistry) degree.
• Five (5) years of experience in a manufacturing leadership role.
• Downstream, fill/finish, as well as buffer and media operations knowledge.
• Experience in process/tech transfer to internal and external GMP manufacturing organization.
• Highly proficient in MS Teams, SharePoint, Smartsheet, and setting up new technology platforms.
• Prior training in continuous improvement tools such as Six Sigma, Lean, Kaizen.
• Experience with facilitating process optimization and process change initiatives in a cross-functional setting.
• Experience in a commercial manufacturing organization.

Role/Site Specific Requirements:

• This role is primarily a Sedentary role. This can include exerting up to 10 pounds of force to move objects.
• Visual acuity such as: working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.)
• Participation in an occupational health program (which can include medical assessment, surveillance, vaccination, and testing)
• Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.).
• The items described here are representative of those that must be met to successfully perform the essential functions of this job.

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.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $125,000.00 - $173,750.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.