Manufacturing Supervisor (Filling), 3rd shift

INCOG BioPharma Services; Fishers (IN); Presencial; USD 70.000 - 110.000; Jornada completa

Descripción de la vacante

INCOG BioPharma Services is seeking a Manufacturing Supervisor to lead aseptic manufacturing operations on a 3rd shift (Sun–Thu, 11:00 PM–7:30 AM) in Fishers, Indiana. The role emphasizes schedule planning, batch record review, and team leadership to meet quality and regulatory standards.

You will coach operators, drive continuous improvement, and participate in deviation investigations, CAPA, and client audits, while aligning with company values and fostering career growth for team members.

Formación

• Knowledge of process control and quality engineering within aseptic manufacturing.
• Understanding of cGMP and related regulatory requirements.
• Experience leading teams and coaching operations staff.
• Familiarity with batch review, deviation investigations, and CAPA.

Responsabilidades

• Batch and resource detail schedule planning.
• Provide floor support and real time batch record review.
• Provide technical support, oversight and team leadership in manufacturing batch activities.
• Coordinate development of individual team members with routine one on ones, training oversight and training opportunities.
• Develop and improve current processes to maintain and control the formulation and filling operations.
• Attend cross functional leadership meetings, support client audits and tours.
• Attend daily batch release and deviation triage meetings as representative for operations.
• Assure compliance with cGMP requirements (current good manufacturing practices).
• Perform GEMBA walks and checks for process improvements.

Conocimientos

Process control

Quality engineering

cGMP knowledge

Aseptic processing

Statistical methods

Communication skills

Leadership experience

Descripción del empleo

The Manufacturing Supervisor is responsible for overseeing production operations, ensuring that all work completed is within appropriate timeframes, delivering daily expectations and assignments. Providing on floor support and review of MBR’s, providing coaching and feedback to operations team. Strategic operator development and career path mentorship. Involvement in manufacturing deviation investigations and CAPA implementation. Batch planning and scheduling and providing process continuous improvement initiatives. Influencing the accomplishments of companywide and team goals and objectives as well as inspiring team members while consistently modeling ALP values in all interactions.

This individual will ensure that all work is carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs) The Manufacturing Supervisor will constantly evaluate the internal processes and procedures and work to create a productive space while maintaining the highest possible quality standards.

This is a 3rd shift role, with typical hours Sunday-Thursday from 11:00PM to 7:30AM.

Essential Job Functions:

• Batch and resource detail schedule planning.
• Provide floor support and real time batch record review.
• Provide technical support, oversite and team leadership in manufacturing batch activities.
• Coordinate the development of individual team members with routine one on ones, training oversite and training opportunities.
• Develop and improve current processes to maintain and control the formulation and filling operations.
• Attend cross functional leadership meetings, support client audits and tours.
• Attend daily batch release and deviation triage meetings as representative for operations.
• Assure compliance with cGMP requirements (current good manufacturing practices)
• Perform GEMBA walks and checks for process improvements.

Job Requirements:

• Knowledge of process control, quality engineering, sampling requirements, statistical techniques, and process capability
• Familiarity with relevant quality and regulatory requirements and trends and cGMP's
• Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders, and technical leaders.
• Knowledge of Aseptic techniques and processing within drug product manufacturing
• 2-4 years demonstrated working knowledge of aseptic manufacturing operations.
• 1-2 years in a people leadership role

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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