Manager, Production; Operations

Production Operations Manager

Build your future at Curia, where our work has the power to save lives.

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.

We proudly offer:

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

Summary:

The Production Operations Manager is a key driver of quality, safety, and operational excellence within Curia's GMP manufacturing environment. Partnering closely with the Director of Production, this role helps ensure Production processes are executed with the highest standards of compliance, employee safety, and product quality while continuously improving operational performance. From developing best practice guidelines and building robust procedural frameworks to training the team and tracking meaningful metrics, this position is instrumental in shaping a Production department that performs at the highest standard every day. This helps ensure that every batch is manufactured safely, compliantly, and with the quality our customers and patients depend on.

The ideal candidate is a collaborative leader, problem solver, and champion of quality who leads through influence and example. They are energized by improving systems, developing people, and strengthening processes. This individual can identify opportunities, address root causes, and implement sustainable solutions that improve safety, quality, compliance, and operational performance.

Essential Responsibilities

Continuous Improvement & Operational Excellence

• Champion a culture where safety, quality, compliance, and continuous improvement are shared responsibilities and embedded in daily decision making.
• Partner with the Associate Director of Production to assess current operational practices, benchmark against industry best practices, and develop a roadmap for ongoing improvement.
• Lead or support the development and implementation of best practice guidelines and standard operating procedures that reflect current cGMP standards and site-specific operational needs.
• Drive root cause analysis and corrective action for operational gaps, deviations, and recurring issues, ensuring sustainable solutions are implemented and sustained.
• Monitor and analyze key department metrics related to safety, quality, compliance, productivity, and schedule attainment; identify trends, communicate insights, and drive actions that improve overall performance.

Program & Procedure Development

• Author, revise, maintain, and approve Production SOPs, work instructions, and MBRs to ensure they are accurate, current, and aligned with cGMP requirements.
• Develop and standardize programs and procedural frameworks that create consistency across shifts and support scalable growth of the Production function.
• Review and approve deviations, CAPAs, validation protocols, and summary reports in support of site compliance goals.
• Develop and maintain systems to track department deliverables and operational improvement initiatives.

Operational Coverage & Support

• Participate in production planning activities and support execution of the weekly production schedule within cleanroom and inspection areas.
• Liaise with internal departments (QA, QC, Engineering, Regulatory, Validation) to facilitate issue identification and resolution.
• Represent the Production department during internal tours, audits, and regulatory inspections as needed.
• Ensure facility, equipment, and personnel always operate in a safe manner.
• Perform hazardous waste handling operations in accordance with Curia procedures, including container filling, identification, labeling, and tracking from generation point to central accumulation area.
• Serve as backup coverage for Production Supervisors during planned and unplanned absences, ensuring continuity of daily manufacturing operations.
• Administer payroll processing on behalf of Production Supervisors when required, ensuring timely and accurate submission.

Training & Capability Building

• Partner with the Training Manager to design and deliver training content to equip Production team members with the knowledge and skills needed to perform at the highest standards of quality and safety.
• Support onboarding and ongoing development of Production staff by communicating expectations, sharing best practices, and serving as a go-to resource for operational questions.
• Coach and support junior team members in understanding GDP and cGMP requirements, fostering a mindset of quality ownership and accountability.
• Collaborate with leadership and area management to ensure talent is recognized and development opportunities are proactively identified.

Quality & Compliance

• Partner with leadership to establish clear expectations, reinforce standards, and cultivate a culture of accountability, engagement, and continuous learning.
• Ensure all Production activities are conducted in compliance with GDP, cGMP requirements and applicable SOPs.
• Conduct, coordinate, and document investigations and CAPAs in a thorough and timely manner.
• Support the department's compliance posture during internal and external audits, including direct interaction with DEA and other regulatory agencies as applicable.
• Maintain consistent communication with project management and supporting departments; surface issues proactively and make recommendations to the Director of Production.

Good Manufacturing & Documentation Practices

Quality is something we take pride in together. You'll perform your work in alignment with cGMP requirements and Curia's standards, which means:

• Perform all documentation in compliance with ALCOA++ principles and site SOPs.
• Adhere to applicable cGMP documents including SOPs, batch records, protocols, change controls, and controlled forms.
• Keep all required cGMP training current and escalate quality concerns along with proposed solutions to the Quality department.

Education & Experience

Required

• High school diploma or equivalent.
• Minimum of 5 to 8 years of experience in manufacturing within a cGMP environment.
• Demonstrated experience contributing to or leading continuous improvement, procedural development, or operational excellence initiatives.

Preferred

• Experience in pharmaceutical manufacturing is strongly preferred
• Bachelor's degree in a relevant scientific, engineering, or operations field.

Knowledge, Skills & Abilities

• Demonstrated ability to foster a culture of safety, quality ownership, and continuous improvement within a regulated manufacturing environment.
• Thorough knowledge and practical understanding of current Good Manufacturing Practices (cGMPs).
• Familiarity with FDA guidelines and regulatory expectations for pharmaceutical manufacturing.
• Ability to influence stakeholders at all levels and drive sustainable change through collaboration, data, and effective communication.
• Proven ability to develop clear, effective written policies, SOPs, and procedural documentation.
• Excellent verbal and written communication skills, with the ability to convey technical information clearly to diverse audiences.
• Skilled trainer and facilitator who can engage Production team members and drive behavioral adoption of new standards.
• Analytical approach to problem-solving, with comfort interpreting and presenting operational data.
• Highly organized with strong prioritization skills; capable of managing multiple concurrent initiatives in a fast-paced environment.
• Collaborative team player who works effectively across functions including Quality, Engineering, and Validation.

Physical requirements

This role regularly requires sitting, standing, and using hands to handle or feel materials. The employee will frequently use hands and arms and communicate verbally and in writing. Occasional walking, climbing, balancing, stooping, kneeling, and crouching may be required. The employee may occasionally lift and/or move up to 50 pounds. Specific vision abilities include close vision and the ability to adjust focus.

Work environment

This position operates in a regulated manufacturing environment. The employee may be occasionally exposed to fumes, airborne particles, toxic or caustic chemicals (Personal Protective Equipment required), wet or humid conditions, moving mechanical parts, high or precarious places, and moderate noise levels. Risk of electrical shock may be present.

The employee will help manage handling of hazardous waste for treatment, storage, and disposal, and must be familiar with applicable training requirements under the Resource Conservation and Recovery Act, including waste labeling, secondary containment, chemical compatibility, storage time limits, container integrity, and proper disposal protocols.

Other Qualifications