INCOG BioPharma Services Careers

Description

Job Summary

The Manager, Incoming Quality Control and Physical Testing provides strategic leadership and functional oversight for three integrated QC programs: Incoming Quality Control (IQC), in-process physical testing, and finished goods physical testing for sterile injectable drug products, including autoinjectors and pre-filled syringes. This role reports to the Senior Director of Quality Control and is accountable for the performance, development, and compliance of the IQC and Physical Testing groups, including direct management of QC individual contributors.

The Manager partners cross-functionally with Quality Assurance, Supply Chain, Manufacturing Science & Technology (MSAT), Manufacturing, and Engineering to ensure that all incoming materials, in-process samples, and finished drug product meet established specifications and quality standards. The role leads strategy and direction across all programs within scope, champions a Quality Mindset with a focus on attention to detail, efficiency, and on-time delivery, and drives continuous improvement through data-driven decision making and systematic problem-solving.

Essential Job Functions

People & Team Leadership

• Directly manage QC individual contributors responsible for IQC and physical testing operations, providing clear direction, performance feedback, and developmental support.

• Foster a culture of quality, accountability, and operational excellence across all IQC functional areas.

• Set team and individual performance goals aligned to departmental KPIs and INCOG quality objectives; conduct formal performance reviews and ongoing coaching conversations.

• Support hiring, onboarding, and training of IQC personnel; ensure training records are current and compliant with applicable SOPs and regulatory requirements.

• Articulate complex technical and quality issues effectively to a range of audiences including site leadership, clients, and regulatory representatives.

Incoming Quality Control (IQC) Program Management

• Oversee the execution and continuous improvement of the material introduction program, including development and maintenance of material specifications and sampling plans.

• Direct the coordination of physical sampling, testing, third-party analytical sampling, and ERP transaction execution for incoming raw materials and components.

• Manage the authoring and issuance of inspection records for incoming raw materials and components.

• Represent IQC in material planning and Ready to Execute meetings, providing updates on material sampling, qualification status, and release readiness.

• Oversee investigations arising from IQC non-conformances and ensure timely disposition of held materials in alignment with QA requirements.

In-Process & Finished Goods Physical Testing

• Provide management oversight for in-process and finished goods physical testing of autoinjectors and pre-filled syringes, ensuring all testing is performed in compliance with applicable SOPs, client specifications, and regulatory requirements (FDA, EMA, ICH, ISO).

• Manage physical testing programs including but not limited to: container closure integrity testing (CCIT); glide force, break-loose force, and extrusion force testing; needle cap and needle shield removal force testing; activation force, trigger force, and injection force testing for autoinjectors; and additional functional force testing using calibrated force gauges.

• Ensure all physical testing instrumentation is maintained, calibrated, and qualified in accordance with site equipment qualification and calibration programs; partner with Engineering and Metrology as needed.

• Oversee the review and interpretation of physical test results; support trending, statistical analysis, and timely escalation of anomalous results.

• Partner with MSAT and Manufacturing to define in-process and finished goods acceptance criteria aligned with product specifications, applicable ISO standards (e.g., ISO 11608 series, ISO 23908, ISO 13485), and client and regulatory requirements.

• Ensure physical testing method development, validation, and transfer activities are executed in alignment with project timelines and quality standards.

Investigations & CAPA

• Lead or provide management oversight for laboratory investigations associated with OOS, OOT, and non-conformance events within IQC and physical testing scope, applying systematic troubleshooting methodologies (e.g., fishbone analysis, 5-Why).

• Ensure investigations are technically sound, completed within established timelines, and closed with appropriate root cause identification and CAPA implementation.

• Monitor CAPA effectiveness and provide escalation to the Senior Director of Quality Control as appropriate.

Quality Systems & Documentation

• Utilize and maintain QMS, LIMS, and related automated systems to manage policies, procedures, test records, and technical reports through their full lifecycle.

• Review and approve QC documentation including sampling plans, test methods, specifications, CoA templates, physical testing protocols, and investigation reports.

• Support preparation, coordination, and hosting of FDA, EMA, and client GMP audits and inspections related to IQC and physical testing activities; serve as a subject matter expert during regulatory interactions.

• Ensure all QC operations comply with FDA 21 CFR Part 211, ICH guidelines, applicable pharmacopeial standards (USP, EP, JP), and EU GMP Annex 1.

Cross-Functional Collaboration

• Partner with QA, Manufacturing, MSAT, Supply Chain, and Engineering to align IQC and physical testing requirements with product development, technology transfer, and commercial manufacturing activities.

• Serve as the QC subject matter expert for physical testing of autoinjectors and pre-filled syringes, representing the function in client, regulatory, and internal technical forums.

• Participate in new product introduction and technology transfer project teams to ensure physical testing readiness, method availability, and equipment qualification ahead of manufacturing milestones.

Special Job Requirements (Qualifications)

Required

• Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, Engineering, or related field).

• Minimum of 7 years of experience in the biopharmaceutical or pharmaceutical industry.

• Minimum of 3 years of people management experience, including direct management of individual contributors in a GMP-regulated environment.

• Minimum of 3 years of hands-on experience in QC physical testing of sterile injectable drug products, including autoinjectors and/or pre-filled syringes.

• Experience operating or managing physical testing equipment in a GMP setting.

• Working knowledge of applicable ISO standards for injection systems and quality management systems (e.g., ISO 11608 series, ISO 23908, ISO 13485).

• Demonstrated experience with practical implementation of FDA, EMA, and other regulatory authority expectations in a QC role.

• Experience with statistical sampling, AQL establishment, and defect criteria development based on ANSI/ASQ Z1.4 and PDA Technical Report guidance.

• Exceptional computer skills with automated data management or analysis systems such as LIMS, JMP, or Minitab.

• Experience participating in regulatory authority inspections or client GMP audits in a QC-facing role.

• Must pass annual health and visual checks, including visual acuity and color blindness assessments; failure to pass annual assessments may result in restriction from applicable duties.

Additional Preferences

• Advanced degree (M.S., M.Eng., or equivalent) in a relevant scientific or engineering discipline.

• Experience with assembled autoinjector functional testing per ISO 11608-5 or equivalent standards.

• Familiarity with USP 1207 Container Closure Integrity Testing guidance.

• Experience with AQL establishment with ANSI requirements and defect criteria based on PDA guidance.

• Experience with defect classification criteria development based on PDA Technical Report No. 79 or equivalent guidance.

• Experience with ERP systems (e.g., SAP) in a GMP manufacturing or CDMO environment.

• Prior CDMO experience with multi-client product management responsibilities.

Benefits

• Paid time off (based on tenure) and 11 total holidays (9 observed + 2 floating).

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

• Choice of health and wellness plans, including FSA and HSA programs.

• Dental and 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.

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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