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Manager of Device Assembly & Packaging Summary

The Manager of Device Assembly & Packaging holds strategic and operational accountability for INCOG's device assembly and packaging (DAP) program, overseeing 24/7 DAP operations across all production shifts at the Fishers, Indiana facility. This role directly leads three Packaging Supervisors - one per shift - ensuring continuity, consistency, and compliance across all activities involving device assembly and packaging activities of vials, syringes, and cartridges. The Manager is the programmatic owner of DAP qualification, yield metrics, and regulatory readiness for the IDAP assembly and packaging function. This position is a critical quality and operational steward, interfacing across Quality, Manufacturing, and Regulatory Affairs to ensure the DAP program meets current GMP requirements and supports INCOG's growth as a world-class sterile injectable CDMO.

Essential Job Functions:

Strategic Leadership & Program Management

• Develop and execute the long-term vision and strategic roadmap for INCOG's DAP program, aligning capabilities with organizational growth, regulatory expectations, and client commitments.
• Establish, monitor, and report on key performance indicators (KPIs) and quality metrics for the DAP function.
• Focused on packaging technology advancement, including evaluation, implementation, and validation of automated packaging systems.
• Drive Lean and Six Sigma continuous improvement initiatives across DAP operations, reducing waste, improving throughput, and driving a high quality standard.
• Represent the DAP function in site leadership forums, client meetings, and project teams, providing expert input on strategy, capacity, and program design for new product introductions.

Operational Management & Multi-Shift Oversight

• Directly lead three Packaging Supervisors across first, second, and third production shifts, providing day-to-day operational direction, performance oversight, and escalation support.
• Oversee 24/7 DAP operations to ensure seamless production continuity, consistent quality, and timely lot release readiness across all shifts.
• Develop and maintain DAP capacity plans and scheduling frameworks that align operator staffing with production demand, campaign schedules, and client commitments.
• Establish structured shift handoff protocols and communication rhythms to ensure operational continuity, accurate information transfer, and rapid escalation of quality or production issues between shifts.
• Manage the DAP departmental budget, including staffing, consumables, equipment maintenance, and capital planning for packaging and assembly technology investments.
• Serve as the primary escalation point for DAP-related production disruptions, non-conformances, and real-time quality events, coordinating cross-functional response as needed.
  

Quality & Regulatory Compliance

• Ensure all DAP operations are conducted in full compliance with current Good Manufacturing Practice (cGMP) regulations, site SOPs, product specifications, and applicable regulatory guidance.
• Serve as a Subject Matter Expert (SME) for regulatory agency inspections - including FDA and EMA - preparing inspection-readiness documentation and representing the program during regulatory site visits.
• Author, review, and approve SOPs, batch records, specifications, and qualification protocols governing all aspects of the DAP program.
• Lead deviation investigations and CAPA development for DAP-related non-conformances, ensuring root cause analyses are thorough, timely, and supported by data.
• Maintain active cross-functional partnerships with Quality Assurance, Quality Control, and Regulatory Affairs to support batch disposition, regulatory submissions, and site inspection readiness.
• Maintain and apply current knowledge of evolving FDA, EMA, and global regulatory standards governing the manufacturing, packaging, labeling and storage of finished medical devices, incorporating regulatory updates into program design and SOP revisions.

People Development & Team Leadership

• Recruit, develop, and retain a high-performing team of Packaging Supervisors and front-line packaging personnel, building organizational capability commensurate with INCOG's growth trajectory.
• Conduct regular performance management and coaching conversations with direct reports, establishing clear expectations, developmental goals, and accountability frameworks aligned to INCOG's performance culture.
• Establish and maintain a comprehensive packaging training program and competency assessment system, ensuring all packaging operators meet and maintain qualification standards consistent with regulatory requirements and program specifications.
• Foster a culture of accountability, continuous learning, and operational excellence within the DAP team, where quality is understood as both a professional standard and a patient safety imperative.
• Champion INCOG's core values - All In, Lean Forward, and Pull for the Team - in every aspect of leadership, creating a team environment where people are empowered, recognized, and invested in a shared mission.
• Identify and develop succession pathways within the DAP organization, ensuring leadership continuity and the ongoing growth of INCOG's internal talent pipeline.

Special Job Requirements:

5+ years of leadership experience in a cGMP regulated environment.

Functional knowledge of cGMP regulations (21 CFR Part 210/211) and device quality system regulations (21 CFR Part 820, ISO 13485).

Understanding of serialization and track-and-trace requirements (DSCSA, EU FMD)

Familiarity with packaging validation, equipment qualification (IQ/OQ/PQ), and process validation.

Ability to don appropriate gowning and access classified cleanroom environments (Grade C/D) in accordance with site SOPs and environmental monitoring requirements.

Willingness to support off-shift operations, including periodic presence on second and third shifts, as required by production schedules, regulatory events, or operational needs.

Ability to stand for extended periods, move freely through active production and packaging areas, and perform direct oversight of DAP activities throughout the facility.

Additional Preferences:

• Bachelor's degree, or higher, in Packaging Engineering, Mechanical Engineering, Industrial Engineering, Pharmaceutical Sciences, or a related field.
• Experience at a CDMO with multi-client product portfolio management.
• Familiarity with device assembly processes, combination product requirements, and assembly validation
• Six Sigma Green Belt or Black Belt certification, or equivalent Lean manufacturing credentials.
• Experience leading FDA, EMA, or other regulatory agency inspections in respective area(s).
• Familiarity with packaging and device assembly operations in a cGMP environment.

INCOG's Benefits:

Paid vacation days, amount based on tenure, and paid sick time

11 observed holidays

401(k) plan with company match up to 3.5% of salary, vested immediately

Choice of health & wellness plans

FSA and HSA programs

Dental & vision care

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.

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