INCOG BioPharma Services Careers

Description

QA Aseptic Principal Job Summary

Join our dynamic Quality Assurance team as a senior technical leader who will shape the future of aseptic manufacturing excellence at INCOG! This is an exceptional opportunity for an experienced QA professional to become the subject matter expert on aseptic processes, contamination control, and regulatory compliance in a fast-growing CDMO environment. You'll work alongside a collaborative team of quality professionals who are passionate about ensuring patient safety while supporting our clients' success in bringing life-saving therapies to market.

As the QA Aseptic Principal, you will serve as the technical authority for all aseptic manufacturing operations, providing critical oversight of media fills, isolator setups, and contamination control strategies. This senior individual contributor role combines hands-on technical expertise with strategic leadership, as you guide training initiatives, represent our systems to regulatory agencies and clients, and ensure our aseptic controls stay ahead of evolving FDA and EMA expectations. You'll have direct impact on product quality and patient safety while helping establish INCOG as the premier CDMO for sterile injectable manufacturing.

Essential Job Functions:

• Aseptic Process Oversight: Provide quality assurance oversight and approval for all media fills, aseptic setup procedures for isolators, and aseptic process validations to ensure compliance with cGMP requirements; develop and improvesystem reporting document and system improvements to support multi-product, multi-client manufacturing operations
• Contamination Control Leadership: Develop, implement, and maintain comprehensive contamination control strategies using risk-based methodology across sterile manufacturing operations. Lead multi-functional risk assessment and other technical exercises to assess and improve aseptic conditions and operations.
• Environmental Monitoring Program Management: Review and approve quarterly environmental monitoring reports, trend analysis, and investigation of excursions to ensure continuous improvement of aseptic conditions
• Aseptic Intervention Guidance: Serve as the technical authority for evaluating and approving aseptic interventions, including risk assessments, corrective actions, and impact evaluations on product sterility assurance
• Training and Development: Design and deliver comprehensive training programs for manufacturing floor personnel and QA staff on aseptic technique, contamination control principles, and regulatory requirements; assess on-the-floor trainers’ expertise and support the training and assessments of floor operations and operators
• Subject Matter Expertise: Function as the primary SME on aseptic manufacturing risks, providing technical guidance on complex sterility assurance challenges and emerging regulatory trends
• Regulatory and Client Interface: Represent INCOG's aseptic systems and controls during FDA, EMA, and client audits, providing technical presentations and responding to regulatory inquiries. Serve as the primary respondent to client and regulatory audits for aseptic topics.
• Regulatory Compliance Assurance: Ensure all aseptic controls and contamination control measures meet current FDA, EMA, ICH, and other applicable guidance documents and regulations
• Proactive Regulatory Intelligence: Monitor and analyze FDA and EMA observations, warning letters, and guidance updates to implement preventive measures and maintain competitive regulatory positioning

Special Job Requirements:

·       Bachelor's degree in Microbiology, Biology, Chemistry, Chemical Engineering, or related scientific discipline

·       Minimum 10 years of experience in pharmaceutical manufacturing with at least 8 years focused on aseptic manufacturing and sterile drug product operations

·       Minimum 7 years of Quality Assurance experience with media fills, environmental monitoring programs, and contamination control in a cGMP environment; proven technical leadership through FDA responses and new product introduction

• Previous experience as a subject matter expert or technical lead in aseptic operations

·       Demonstrated experience with FDA and/or EMA inspections and regulatory interactions

• Experience with client audits and technical presentations to external stakeholders

·       Demonstrated experience in aseptic operations optimization and improvements, including Annex 1 remediations and ensuring

·       Strong knowledge of USP <1116>, FDA Guidance for Industry on Sterile Drug Products, and EU GMP Annex 1

·       Experience with isolator technology, RABS (Restricted Access Barrier Systems), and aseptic fill-finish operations

·       Proven track record in training development and delivery for technical topics

·       Excellent written and verbal communication skills with ability to present to senior management, clients, and regulatory agencies

·       3-5 years of experience in CDMO or contract manufacturing environment supporting multiple clients and diverse product portfolios

Additional Preferences:

• Advanced degree (MS/PhD) in relevant scientific discipline
• Professional certifications such as ASQ CQE, CQA, or equivalent quality certifications

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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