Global Technical Operations Specialist

Global Technical Operations Specialist

remote

Remote, Remote, US .

full-time
. February 24, 2026

Description

** Company Bio:*
* Medexus Pharma is a leading specialty pharmaceutical company with a focus on the therapeutic areas of rheumatology, auto-immune disease, specialty oncology, allergy, and pediatric diseases. We provide market-leading prescription and over-the-counter brands to patients and healthcare professionals, which we believe greatly enhances quality of life and promotes a healthy lifestyle. We have a strong North American commercial platform, and we currently operate through two unique segments:
Medexus Pharma Canada and Medexus Pharma USA. Innovation is a driving force for our company. As a result, we are continuously licensing and/or acquiring new products and solutions aimed at addressing the essential needs of consumers, patients, and healthcare partners.

** Role Overview*
* The Global Technical Operations Specialist supports both Manufacturing Science and Technology (MSAT) and Quality Control (QC) functions across Medexus's product portfolio. This individual provides scientific and operational oversight for external manufacturing and testing partners to ensure product supply, process robustness, and analytical consistency. The role combines process understanding, analytical expertise, and technical leadership to manage manufacturing and testing lifecycle activities for commercial and clinical programs.

The Specialist will support ongoing process monitoring, technology transfers, method lifecycle management, and regulatory readiness, collaborating closely with Quality Assurance, Regulatory Affairs, and Supply Chain.

** Key Responsibilities*
* · Manufacturing Science & Technology (MSAT):

· Provide technical oversight for biologic drug substance and drug product manufacturing at CMOs, ensuring consistency and compliance.

· Support process monitoring, trending, and investigations to maintain control of critical process parameters.

· Contribute to process validation, comparability assessments, and process lifecycle management.

· Participate in technology transfers of analytical methods and manufacturing processes between sites.

· Identify and implement process and analytical improvements to enhance product quality and operational efficiency.

· Support authoring and review of technical documentation including process descriptions, technical reports, and regulatory submissions.

· Quality Control (QC):

· Coordinate analytical activities with contract laboratories, including method qualification, validation, and performance monitoring.

· Review and trend analytical data for product release and stability programs.

· Evaluate test methods and data for accuracy, compliance, and timeliness.

· Support OOS/OOT investigations, deviations, and change controls in partnership with Quality and external partners.

· Compile data for Annual Product Reviews, comparability studies, and method lifecycle reports.

· Remain current on global regulatory and compendial requirements (USP, EP, ICH).

· Cross-Functional Support:

· Collaborate with Quality, Regulatory, and Supply Chain to ensure compliant and timely product supply.

· Support technical assessments for vendor changes, process improvements, and investigations.

· Provide audit and inspection support as needed.

· Contribute to technical planning and risk mitigation strategies for commercial and clinical operations.

Education and Experience

· BS/BA with 6+ years, or MS with 4+ years of experience in MSAT, QC, or process development within biotechnology or pharmaceuticals including on-the-bench experience.

· Strong background in biologics (recombinant proteins, particularly factor IX or similar).

· Experience supporting external manufacturing or testing organizations under cGMP.

· Knowledge of analytical techniques including HPLC, CE, ELISA, and bioassays.

· Solid understanding of upstream/downstream manufacturing processes and process analytics.

· Working knowledge of global regulatory expectations (FDA, EMA, Health Canada, ICH).

· Excellent data interpretation, technical writing, and communication skills.

· Proven ability to collaborate cross-functionally and manage multiple…