SOKOL GxP Services

Software Engineer

• Responsible for supporting MS&T Active Pharmaceutical Ingredient (API) and Drug Product (DP) development-to-launch teams.
• Design and run experiments.
• Perform risk assessments, including but not limited to Material and Process Risk assessment, Nitrosamines Risk Assessment, Elemental Impurities Risk assessment etc.
• Complete, analyze and present data analysis.
• Support tech transfer activities in the form of generating test plans, change controls, executing and compiling results into reports.
• Supports validation efforts in the development of validation strategies and testing plans.
• Provide input into process related investigations and complete MST investigations as required.
• Advise on root-cause analysis of undesired trends or deviations related to process equipment.
• Support monitoring of studies at manufacturing areas, Contract Manufacturers, as needed.
• Support the Change Control process.
• Position does handle hazardous material.

Process Engineering Scientist

Supply Chain

• The Supply Chain Planner will manage material planning and purchasing activities to ensure on-time delivery and optimal inventory levels for clinical trial product manufacturing.
• This role coordinates with manufacturing, QA, QC, and cross-functional teams to align production schedules, resolve material shortages, and maintain supplier relationships.
• Responsibilities include developing replenishment strategies, managing supply forecasts, and driving process improvements within cGMP operations.

Supply Chain Planner

Technical Writer

• Qualify alternative raw material suppliers and partner with Procurement to identify new options.
• Recommend and lead necessary testing to qualify materials for GMP manufacturing.
• Author technical equivalency assessments, specification comparisons, material characterization reports, and change controls.
• Support material and consumable manufacturing investigations.
• Manage supplier change notifications and evaluate risks to maintain GMP compliance.
• Contribute to risk assessments and material specification development.
• Partner with cross-functional teams to deliver results in a fast-paced, matrixed environment.

Scientist – GMP Quality, Technical Writing

Project Manager

• Oversee the planning, execution, monitoring, and closure of supply chain projects.
• Develop project timelines, budgets, and resource planning while managing risk and scope changes.
• Facilitate communication between stakeholders to ensure project alignment with business objectives.
• Implement best practices in supply chain management and project management methodologies.
• Conduct regular status meetings to report on project progress and address any issues or challenges.
• Lead continuous improvement initiatives to optimize performance across the supply chain.
• Oversee and lead new product launches from North American CMOs; develop and maintain launch-related metrics and dashboards to ensure visibility and drive action.
• Partner with the Launch Excellence team to ensure alignment of product flows, master data, and forecasts.
• Support ExM Virtual Plant Teams with tech transfer projects, ensuring supplier capability to meet all requirements.

Senior Project Manager – Supply Chain

• Author and co-author CMC content for CTD Quality sections, ensuring alignment with regulatory strategy and scientific accuracy.
• Plan and lead submission kick-offs, managing detailed timelines, deliverables, and cross-functional collaboration.
• Coordinate and track submissions, including responses to Health Authority questions, data verification, and final dossier preparation.
• Partner with subject matter experts (SMEs) across CTDO to identify source documents, align on timelines, and deliver approved technical content.
• Ensure consistency, clarity, and accuracy of messaging across all CMC documentation.
• Review and reconcile comments with SMEs, manage revisions, and facilitate efficient comment resolution.
• Provide oversight for eCTD Modules 2.3 and 3, ensuring compliance with formatting, structure, and regulatory requirements.
• Collaborate with external partners as needed to review and finalize CTD content.
• Drive process improvements and contribute to best practices in regulatory writing and document management.
• Mentor and train team members on technical writing standards, systems, and submission processes.

Process Engineering Scientist

Supply Chain Planner

Scientist – GMP Quality, Technical Writing

Senior Project Manager – Supply Chain

Technical Writer – CMC Regulatory Submissions