Consultant I

This is a fully remote position, open to applicants in United States.

📋 Description

• Create and oversee comprehensive CMC project plans and timelines that encompass drug substance, drug product, analytical, quality, and regulatory workstreams.

• Identify project dependencies, milestones, essential activities, and resource needs.

• Manage the full cycle of clinical supplies operations, covering demand forecasting, manufacturing scheduling, packaging, labeling, release, distribution planning, and inventory oversight.

• Supervise packaging and labeling processes for investigational products, ensuring compliance with GMP, study, and regulatory standards.

• Develop and track project budgets, forecasts, and program financials.

• Evaluate vendor invoices, manage project scope, and oversee change orders.

• Drive project risk management by identifying, monitoring, mitigating, and escalating risks and issues.

• Coordinate collaboration among cross-functional teams and external partners, including CDMOs, CMOs, laboratories, and specialized service providers.

• Lead team meetings, governance reviews, and client status updates.

• Record decisions, action items, and project progress.

• Prepare and present project status reports, dashboards, and milestone evaluations.

• Establish and nurture strong client relationships as a reliable project management resource and delivery partner.

• Assist in business development through scope definition, proposal assistance, and pinpointing opportunities to broaden client engagements.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related scientific field is required.

• At least 5 years of project management experience in pharmaceutical development or CMC programs is required for Consultant Level.

• A minimum of 8 years of project management experience in pharmaceutical development or CMC programs is required for Senior Consultant Level.

• Proven experience in managing cross-functional CMC development programs within biotechnology, pharmaceutical, CDMO, or consulting sectors.

• Demonstrated expertise in clinical supplies management, including supply planning, packaging, labeling, inventory management, and clinical trial distribution.

• Experience in overseeing external vendors and development partners, including CDMOs, CMOs, contract laboratories, and logistics providers.

• Proficiency in project management tools and software, such as Microsoft Project and related planning and reporting applications.

• Strong comprehension of pharmaceutical development and CMC activities across drug substance, drug product, analytical, quality, and regulatory functions.

• Knowledge of GMP requirements and regulations regarding clinical packaging and labeling for investigational products.

• Exceptional skills in project planning, scheduling, budget management, risk management, and organization.

• Ability to handle multiple projects concurrently while ensuring high quality and client satisfaction.

• Excellent verbal and written communication abilities.

• Strong problem-solving, decision-making, and issue-resolution skills.

• Capability to work independently in a client-facing consulting environment while collaborating with cross-functional teams.

• Proven ability to forge trusted relationships and influence outcomes among internal and external stakeholders.

• Experience with regulatory submissions and interactions with health authorities is preferred.

• Familiarity with consulting, fee-for-service, or multi-client environments is preferred.

• Experience in commercial supply chain operations, third-party logistics providers, serialization, and distribution activities is preferred.

• Exposure to small molecules, biologics, and advanced therapies is preferred.

• PMP or equivalent project management certification is preferred.

• Syner-G cannot sponsor or take over sponsorship of an employment Visa.

🏝️ Benefits

• Competitive base salary in the market.

• Annual incentive program.

• Comprehensive benefits package.

• Generous flexible paid time off policy.

• Company-paid holidays.

• Flexible working hours.

• Most positions offer fully remote work options.

• Opportunity to work “almost anywhere.”

• Continuous recognition and career development opportunities.

• Support for learning and development.

• Financial rewards.

• Programs focused on leadership and innovation.