Job Description

Operations Manager Summary (2nd shift)

The Operations Manager is responsible for the implementation and establishment of effective management of labor, productivity, quality control, and safety measures. The Operations Manager will; ensure safe and efficient operations. Serve as a company representative during audits, client tours and regulatory agencies. Enhance the operational procedure, systems, and principles in the manufacturing areas look for opportunities to expand and enhance our processes and systems. Carry out supervisory responsibilities and ensure that all work completed is within appropriate timeframes, delivering daily expectations and assignments as well as provide on floor support and review of MBR’s, and coaching and feedback to the operations team.

Operations manager duties and responsibilities may include interviewing, selection, and hiring; training new and existing employees; planning, assigning, and directing work; authoring and discussing with employees performance appraisals; addressing employee performance and corrective action plans; employee motivation and rewards. Organizing the budget of the company in collaboration with the Vice President of Operations.

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 Operations Manager will constantly evaluate the internal processes and procedures and work to create a productive space while maintaining the highest possible quality standards.

Key responsibilities:

• Provide technical support, oversite and team leadership in manufacturing batch activities.
• Interviewing, selection, and hiring; training new and existing employees.
• Develop and improve current processes to maintain and control the formulation and filling operations.
• Planning, assigning, and directing work
• Communicate job expectations; planning, monitoring, appraising, and reviewing job contributions
• Develop, implement, enforce and evaluate operational processes, procedures and policies

Special Job Requirements:

• Strong knowledge of process control, quality engineering, sampling requirements, statistical techniques, and process capability
• Knowledge of 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.
• Strong knowledge of Aseptic techniques and processing
• 8 years demonstrated working knowledge of pharmaceutical manufacturing operations.
• 5 years in a people leadership role

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we are building 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.

We are in the process of constructing the GMP facility and organization from the ground-up, which gives us the opportunity to leverage the knowledge we’ve gained over our careers to “do it right” in all respects. 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.

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.