Director, Manufacturing & Sterile Operations
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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.
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The Director, Manufacturing Drug Product (Aseptic Filling) is a leader for multiple segments of the PET (Process Execution Team). In this capacity, the Director oversees and leads the PET Operations Segment(s) to ensure high quality product in accordance with the PET operating strategy. As a responsible leader for the PET, this must be done while inspiring team engagement, facilitating a collaborative work environment and ensuring compliance to cGMP, other regulatory, and SOX requirements, as well as EHS obligations and Resilience standards.
- Provides direction to PET leadership and employees in the efficient use of equipment (multiple formulation and filling lines running 24x7) and materials to produce quality products in accordance with PET Planning.
- Leads support teams responsible for batch scheduling and process improvement projects.
- Promotes safe work practices during all aspects of production and ensures all external and Resilience EHS standards are consistently held at high bar.
- Ensures effective training of PET employees on equipment, processes and Standard Operating Procedures is met. Partners with PET leadership to develop training plans and provide resources for training.
- Drives compliance of cGMP during production of products to meet all FDA and international regulations. Responds to internal audit observations.
- Promotes a positive work environment through active communication and listening to inform team members and respond to their concerns, recognizing and celebrating high performance, quickly managing poor performance and enables learning and career development.
- Ensures proper documentation practices are maintained consistently to company standards in manufacturing documents, training documentation, and production logs
- Proactively monitors across org for functional area deviations, provides direction in 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 using team driven processes and key performance indicators.
- Collaborates with PET Engineers, as applicable, to optimize process performance.
- Participates in the design, selection, installation and qualification of new equipment, facilities, and processes.
- Consults, reviews, approves, and implements change control.
- 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.
- Maintains presence across multiple operating shifts as appropriate.
- Significant experience in GMP or regulated production environment evidencing increasing managerial and production expertise
- Previous experience leading large scale commercial pharmaceutical or device operations team
- Deep knowledge of FDA cGMP’s and evidence of ability to apply in an operations setting
- Proven ability to apply Lean and/or Six Sigma to improve manufacturing processes.
- Strong two-way communication and team leadership skills, including the ability to manage and participate in cross-functional teams.
- Agile troubleshooting and problem-solving skills.
- Bachelor of Science in Administration, Business, Engineering, Pharmacy, or related Science.
- Previous experience in Aseptic Filling operations
- Previous operations start-up experience
- Ability to use ERP and other manufacturing systems.
- Training or experience in formulation, filling, packaging, validation, technology transfer, change control.
- Project management skills with demonstrated 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.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 annualized base pay hiring range for this position is $150,000.00 - $217,500.00. 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.