Jobs at BioPharma Consulting JAD Group

Provides engineering and compliance support for manufacturing automation, equipment, utilities, calibration, maintenance, validation, and system upgrades in a regulated environment. Supports FDA inspections, investigations, audits, SOP and training implementation, environmental monitoring, high-purity water systems, sanitization changes, and continuous improvement initiatives. Collaborates cross-functionally with maintenance and plant engineering teams to ensure system performance and regulatory compliance.

Leads complex engineering, process optimization, troubleshooting, system modifications, experiments, and capital projects across pharmaceutical operations and manufacturing. Develops engineering procedures, technical solutions, budgets, validation documentation, and project schedules while coordinating engineers, technicians, consultants, and cross-functional teams. Requires pharmaceutical process knowledge, GMP/GLP familiarity, validation experience, and the ability to manage multiple projects and regulated manufacturing initiatives.

Provides technical quality assurance expertise in a regulated manufacturing environment. Reviews and approves manufacturing, validation, environmental, and quality documentation; leads investigations, incident triage, change control, audit readiness, and compliance assessments. Owns site quality procedures and collaborates with manufacturing, facilities, utilities, validation, and process development teams. Supports regulatory interactions, data trending, process validation, and new product introduction activities.

Leads scientific studies supporting drug product development, aseptic filling, process characterization, validation, and commercial manufacturing readiness. Designs experiments, analyzes data, develops protocols, authors technical documentation, introduces process improvements, and collaborates with Manufacturing, Quality, Engineering, Regulatory, and Technical Services teams. Provides technical leadership, mentors junior staff, manages project timelines, and supports GMP compliance and data-driven manufacturing decisions.

Leads complex quality investigations supporting cell therapy manufacturing, including deviations, CAPAs, change controls, and analytical/QC investigations. Performs root cause analysis, coordinates cross-functional SMEs, ensures compliant record closure, supports audits and inspections, identifies systemic issues, and mentors junior investigators. The role requires strong knowledge of cGMP, regulatory requirements, electronic quality systems, technical writing, and regulated manufacturing environments.

Owns end-to-end quality investigations for cell therapy manufacturing, including deviations, CAPAs, change controls, and analytical/QC investigations. Leads triage, root cause analysis, SME coordination, documentation, effectiveness checks, and record closure within an eQMS. Partners with Manufacturing, QC, QA, MS&T, and Engineering to support cGMP compliance, audit readiness, continuous improvement, and reduction of recurring deviations.

Leads complex quality investigations for cell therapy manufacturing, including deviations, CAPAs, change controls, and analytical/QC investigations. Performs root cause analysis, risk assessments, effectiveness checks, and data trending within an eQMS. Partners with cross-functional teams, supports audits and regulatory inspections, identifies systemic manufacturing issues, and mentors investigators while ensuring compliant, timely record closure.

Manages cross-functional biopharmaceutical change-control projects for cell and gene therapy programs. Maintains integrated project plans, tracks milestones and risks, coordinates stakeholders, drives completion of changes, and prepares status communications, meeting materials, action logs, and risk registers. Ensures activities follow SOPs and GxP requirements while applying knowledge of biotechnology, GMPs, drug development, regulatory requirements, and risk management.

Provides advanced engineering and technical support for HVAC, chilled water, cooling tower, and site utility systems in regulated pharmaceutical or biotech facilities. Optimizes maintenance programs, troubleshoots complex issues, supports capital projects, coordinates contractors and engineering firms, and ensures quality-system compliance. Manages deviations, CAPAs, change controls, documentation, electronic facilities forms, pest control programs, and inspection readiness while supporting continuous improvement and regulatory requirements.

Manages department-level projects spanning multiple departments, overseeing planning, schedules, budgets, resources, risks, reporting, compliance, and completion. Coordinates cross-functional teams, communicates with stakeholders and sponsors, identifies process improvements, maintains project documentation, and supports technical, financial, and organizational decisions. The role may supervise project support staff, conduct performance reviews, prepare presentations and reports, and lead initiatives within the project management function.

Supports biopharmaceutical manufacturing and quality systems, including procedures, process monitoring, deviations, non-conformances, CAPA, investigations, training, process validation, and new product introductions. Troubleshoots production processes, analyzes performance data, supports regulatory inspections, and contributes to process or equipment improvements. The role requires cross-functional collaboration with manufacturing, process development, and quality teams in a regulated GMP environment.

Oversees department-level projects spanning multiple organizations, managing planning, schedules, budgets, resources, risks, compliance, reporting, and stakeholder communication. Develops process improvements, supports decision-making, coordinates project teams, and provides guidance to project staff. Requires extensive project management experience, strong organizational and communication skills, and proficiency with project management tools and business software.

Supports pharmaceutical quality control operations through routine and non-routine HPLC, UPLC, and microbiological testing; data review and trending; investigations; lab equipment and inventory maintenance; method transfers and validation; controlled document updates; and regulatory inspection readiness. The role requires GMP and GLP compliance, weekend lab coverage, cross-functional collaboration, and support for continuous improvement initiatives.