Job Description

The Production Supervisor leads a sound, efficient, safe, and effective production operation and implements our vision for this business-critical function at Cresilon. The Production Supervisor oversees optimal and cost-effective aseptic manufacturing practices in a fast-paced environment through collaboration with stakeholders, production engineers and technicians. The Production Supervisor should have a strong operational, quality, compliance, and technical background. This is often a hands-on role working closely with the production team to troubleshoot process and equipment challenges. They must ensure production processes comply with local, State, and Federal regulations, including current Good Manufacturing Practices (cGMP).

This is a full-time, on-site position, located in Brooklyn, New York. It is a multi-faceted role in a highly collaborative environment that will require strong leadership and focused execution in pursuit of maximizing production outputs, on-time customer shipping and overall robust manufacturing processes.

Shift Timing:

Second shift is currently defined as 11:00am-7:30pm. This timing will shift to 3:00pm-11:30pm within ~6 months.

During training, the 2nd shift production supervisor will occasionally be required to work 1st shift (7:00am-3:30pm).

Hours may vary depending on company requirements.

Responsibilities:

· Organizes, and leads production operations and associated production activities to drive production target while maintaining quality, cost, and customer service expectations within a safe working environment.

· Manages a team of production technicians.

· Manages production KPIs including, labor budget, yield, and OEE, and ensures target production metrics are met.

· Communicates production results and challenges. Troubleshoots and implements solutions to issues quickly and efficiently to avoid potential delays.

· Ensures all tasks associated with manufacturing operations are performed in accordance to cGMP and SOPs, and ensures batch record requirements are completed in a timely manner.

· Supervises all aspects of production, including the assembly, disassembly, cleaning, and storage of manufacturing equipment, the cleaning of the cleanroom facility, formulation, filling/finishing, and product shipping operations related to the second shift of technicians.

· Acts as a subject matter expert on Manufacturing Practices, including in aseptic behaviors and practices.

· Implements continuous improvement, leveraging expertise in Six Sigma, Lean, or Toyota Production System (TPS) approaches.

· Adheres to all workplace safety laws, regulations, standards and practices and actively advances a culture of safety within their team and organization.

· Resolves or escalates any problem occurring in the area that affects product quality, safety, and other aspects of production line performance.

· Demonstrates the ability to properly operate equipment, perform equipment set-up/change-over/cleanups, assist in preventative maintenance and troubleshoots equipment problems to achieve optimum production targets.

· Establishes a working environment that fosters participation within and between teams.

· Hires, trains, develops, disciplines, and discharge production technicians.

· Develops, mentors, and supports production technicians in assisting continuous improvement efforts, improving employee engagement, and supporting business growth.

· Ensures compliance with Quality Assurance and Quality Control requirements and participates in timely investigations and implementation of corrective and preventative action.

· Ensures records are maintained per SOPs and cGMP requirements.

· Generates production batch procedural documentation, manages change assessments, and nonconformance reports.

· Creates, updates, reviews, and maintains production-related SOPs.

· Reviews and approves documents, including standard operating procedures, batch records, and material specifications.

· Leads the execution of and training for newly transferred or existing products and processes.

· Leads and assists with the continuous improvement of production operations and procedural documentation.

· Organizes and leads initial and on-going training of new and existing personnel.

· Maintains appropriate inventory of production supplies and materials.

· Ensures on time delivery and quality through accurate work order completions, on time shipping, and accuracy of inventory consumption.

· Other responsibilities as required or assigned by management.

Requirements

Education : Bachelor’s degree with a focus on science or engineering is preferred.

Qualifications :

· 3+ years of relevant cGMP manufacturing experience with a minimum of one year managing hands-on manufacturing operations with direct supervisor responsibility.

· Experience in GMP cleanroom operations, including aseptic processing.

· Strong leadership skills with the ability to motivate staff members and develop a culture of operational excellence

· Experience in supporting regulatory inspections and audit readiness activities is required.

· Experience with lean manufacturing or six sigma.

· Working knowledge of quality management systems.

· Previous experience in any of the following areas is preferred: formulation, fill and finish operations, and packaging.

· Ability to multitask and prioritize work, while remaining detail oriented.

· Team oriented with the ability to build relationships and influence and/or enforce decisions with peers and management in a proactive manner.

· Strong leadership skills with a proven ability to build, motivate, and maintain a high performing, cohesive team with the ability to inspire passion and commitment and lead and facilitate operational and cultural change initiatives.

· Demonstrated experience training technical personnel is required.

· Adept at motivating others in a deadline driven environment.

· Proven history of owning quality and efficiency KPIs and driving them in a positive direction

· Proven leadership skills, capability and ability to mentor, coach, and develop a team and other associates

· Organizational and time management skills with the ability to prioritize a variety of tasks/projects.

· Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner.

· Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively.

· Excellent verbal and written communication skills required.

· Demonstrated understanding of aseptic processing and microbial control concepts preferred.

· Strong computer skills, with proficiency in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint required.

· Legal authorization to work in the United States is required.

Physical Requirements:

· Ability to become gowning qualified to work in a cleanroom environment.

· Ability to climb, balance, stoop, reach, stand, and walk.

· Ability to bend, twist, push, lift, and grasp.

· Ability to speak, listen, and understand verbal and written communication in English.

· Ability to pass respirator fit test.

· Ability to work for extended periods of time with appropriate respiratory equipment.

· Manual dexterity to perform delicate manipulations.

· Ability to perform repetitive motions, including the substantial movement of wrists, hands, and or fingers.

· Ability to lift 50 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects.

· Visual acuity to perform close activities such as: reading, writing, and analyzing; and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations

Benefits

· Competitive annual base salary range of $90,000 - $120,000, depending upon job level and qualifications.

· Paid Vacation, Sick, & Holidays

· Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

· Company Paid Life and Short-Term Disability Coverage

· Work/Life Employee Assistance Program

· 401(k) & Roth Retirement Savings Plan with company match up to 5%

· Monthly MetroCard Reimbursement

Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

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