Job Description
Our Work Matters
At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
As a Production Supervisor, you will play a critical role in leading sterile manufacturing operations within our Sterile Production Manufacturing (SPM) facility. You will provide leadership and oversight for production personnel, support services operations, and union operators while ensuring activities are performed safely, efficiently, and in compliance with current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs). This role is responsible for driving operational excellence, maintaining compliance, supporting employee development, and ensuring the successful execution of production schedules that help deliver life-changing therapies to patients around the world.
Responsibilities
Production Leadership & Operations
• Lead and supervise sterile manufacturing operations, ensuring activities are performed safely, efficiently, and in compliance with current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs).
• Provide day-to-day direction and support for production personnel, including staffing, scheduling, training, coaching, performance management, and employee development.
• Maintain operational readiness and support production schedules while driving labor efficiency and continuous improvement initiatives.
Quality, Compliance & Safety
• Ensure compliance with cGMP requirements, aseptic processing standards, safety regulations, and site procedures.
• Perform area audits, review production documentation and batch records, investigate deviations, and support root cause analysis and corrective and preventive actions (CAPAs).
• Partner with Environmental, Health & Safety (EH&S) and Quality teams to maintain a safe and compliant manufacturing environment.
Planning, Communication & Continuous Improvement
• Coordinate with Manufacturing, Materials, Planning, Quality, and other cross-functional teams to support production objectives and resolve operational challenges.
• Manage inventory, departmental resources, and supply requirements to support uninterrupted operations.
• Support budget activities, special projects, process improvements, and other initiatives that enhance operational performance and manufacturing excellence.
Qualifications
• Education: High School Diploma or Associate Degree required; Bachelor's degree in Engineering, Chemistry, Computer Science, or other Technology or Life Science field preferred.
• Experience: 3+ years of previous supervisory experience required and/or a combination of education and experience. Pharmaceutical or manufacturing experience highly desirable.
• Language Skills: Effective written and oral communication skills required. Excellent written skills in English. Good verbal communication and ability to coach and provide guidance to others.
• Computer Skills: Computer literate, with skills in managing Microsoft Applications, PLS, and TrackWise.
• Reasoning Ability: Demonstrated reading comprehension and writing proficiency at a level that meets role requirements.
• Ability to effectively communicate within a diverse group, resulting in desired outcomes.
• Proven record of problem-solving, decision-making skills, and application of process improvement tools.
• Self-starter, team player, with strong interpersonal and coaching skills.
Physical Requirements
• Ability to stand upright for several consecutive hours, in the absence of any medical restrictions that could restrict completion of required duties.
• Additional physical requirements may be line and product-specific.
• Job tasks may include bending, twisting, and lifting items up to 35 pounds at a frequency that meets position requirements.
• This position requires standing and frequent walking between production areas to supervise operations.
• This position works around moving machines and is exposed to temperature changes.
• Must be able to wear personal protective equipment (PPE) as required.
• Maintaining aseptic area certification may be required.
• Aseptic gowning procedures will be required.
• Aseptic gowning requires all body parts to be completely covered (gowned) for substantial periods of time.
Work Environment & Schedule Requirements
• Position requires regular onsite attendance and cannot be performed on a remote or telecommute basis on a temporary, short-term, or long-term basis.
• Practices and promotes a safe working environment at all times.
• Must have the ability to simultaneously multitask across multiple capabilities and functions and handle multiple competing priorities and requirements.
• Responsibilities include performing site and functional responsibilities, responding to email and phone communications, and attending meetings.
• Note that these activities may not be limited to core business hours or physical presence at the site.
• Must have the ability to effectively manage strict production, time, and performance deadlines.
• Must be willing to work a variable and irregular shift beyond the hours typically defined as a regular workday, which may or may not include weekends and holidays.
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California residents should review our Notice for California Employees and Applicants before applying.
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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