Jobs at INCOG BioPharma Services

Provides onsite and remote technical support for end users, resolving hardware, software, access, connectivity, and device issues. Manages tickets, onboarding, offboarding, workstation deployment, Intune administration, asset records, conference room technology, and knowledge-base documentation. Supports regulated GxP and 21 CFR Part 11 requirements, educates users on cybersecurity practices, and escalates complex issues according to established procedures.

Senior Project Manager responsible for leading global biopharmaceutical manufacturing projects, technology transfers, commercial product launches, and large-budget initiatives. The role manages timelines, budgets, risks, corrective actions, cross-functional coordination, customer relationships, project governance, and team development. It requires advanced drug development knowledge, substantial biopharmaceutical project management experience, leadership skills, and the ability to manage multiple complex projects.

Support and administer SAP Business ByDesign across finance, procurement, inventory, warehousing, integrations, user access, and master data. Troubleshoot incidents, manage tickets and changes, maintain validated GxP-compliant system documentation, support CSA and audit readiness, monitor integrations, and assist with training and continuous improvement. The role requires SAP ERP administration experience, familiarity with GAMP 5 and 21 CFR Part 11, and strong documentation and stakeholder communication skills.

Supports aseptic pharmaceutical manufacturing through deviation investigations, CAPA implementation, SOP and work-instruction development, root cause analysis, process improvement, FMEA participation, batch-record review, and productivity studies. Serves as a subject matter expert for preparation, formulation, and filling processes while partnering with operations, quality, and cross-functional teams. Uses manufacturing systems and data-analysis tools to maintain data integrity, improve process capability, and ensure cGMP, safety, and regulatory compliance.

Supports pharmaceutical technical transfer, process validation, GMP manufacturing, and continued process verification for clinical and commercial programs. Scales processes to full-scale production, selects equipment and single-use components, authors GMP documentation, monitors process data, troubleshoots manufacturing issues, leads investigations, and provides technical oversight for qualification and validation activities. Collaborates with operations, validation, customers, and cross-functional teams while managing critical-path timelines.

Owns batch-impacting deviation management in Veeva QMS from initiation through closure. Drives cross-functional investigations, reviews technical and compliance quality, supports batch disposition, manages CAPAs and related quality records, tracks KPIs, presents performance data, coaches investigation owners, and improves deviation workflows and procedures in a cGMP biopharmaceutical manufacturing environment.

Authors and maintains engineering GMP documentation, including SOPs, work instructions, validation protocols, specifications, and change controls. Manages document lifecycles in an electronic document management system, supports deviations, root cause analyses, CAPAs, and master batch records, and develops training materials. Conducts document gap assessments, supports audits and inspections, and maintains an organized documentation library. Requires collaboration with engineering, manufacturing, quality, and technical teams in a regulated pharmaceutical manufacturing environment.

Reviews parenteral manufacturing batch records for cGMP, regulatory, and SOP compliance. Identifies corrections and deviations, coaches operations personnel, supports investigations and CAPA implementation, and contributes to SOP and work-instruction development. Coordinates reviews within production timelines and uses computerized systems to verify data integrity. Partners with Operations, Quality Systems, and other technical teams to support timely batch release and continuous compliance improvement.

Serve as the primary off-shift HR partner for a GMP-regulated biopharma facility. Advise operations and quality leaders, manage employee relations investigations, leave administration, performance improvement plans, compliance audits, HR policies, benefits questions, payroll training, workforce analytics, and cross-shift handoffs. The role is on-site Tuesday through Saturday from 4:30 p.m. to 12:30 a.m.

Leads supplier qualification, approval, auditing, documentation, change notification review, complaint investigations, risk assessments, quality agreements, and supplier quality metrics in a pharmaceutical GMP environment. Partners with Purchasing, Quality Operations, suppliers, and external auditors to maintain compliance, manage supplier risks, support product introductions, and drive quality improvements.

Leads the strategy, governance, implementation, integration, validation, and lifecycle management of regulated enterprise systems, including ERP, MES, CMMS, and VMS platforms. Oversees cross-functional applications teams, vendors, system architecture, data integrity, compliance, business process ownership, change management, operational support, KPIs, and continuous improvement across manufacturing, quality, supply chain, engineering, finance, and warehouse functions.