Consultant I

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

💼 Consultant

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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Syner-G BioPharma Group

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Syner-G BioPharma Group is the world's leading provider of chemistry, manufacturing and controls (CMC), regulatory affairs, and medical writing solutions for the biopharma sector. They offer comprehensive services that navigate clients through the complexities of pharmaceutical development, regulatory submissions, and quality compliance, ensuring high-quality outcomes. With a multidisciplinary team, Syner-G integrates science, engineering, and regulatory expertise to support drug development from pre-IND to post-approval phases, enabling timely submissions and patient safety adherence.

📋 Description

• Develop and manage integrated CMC project plans and timelines across drug substance, drug product, analytical, quality, and regulatory workstreams • Identify project dependencies, milestones, critical path activities, and resource requirements • Coordinate end-to-end clinical supplies operations, including demand forecasting, manufacturing scheduling, packaging, labeling, release, distribution planning, and inventory management • Oversee packaging and labeling activities for investigational products in compliance with GMP, study, and regulatory requirements • Develop and monitor project budgets, forecasts, and program financials • Review vendor invoices, manage scope, and administer change orders • Lead project risk management by identifying, tracking, mitigating, and escalating risks and issues • Coordinate cross-functional teams and external partners, including CDMOs, CMOs, laboratories, and specialty service providers • Facilitate team meetings, governance reviews, and client status meetings • Document decisions, action items, and project updates • Prepare and communicate project status reports, dashboards, and milestone reviews • Build and maintain strong client relationships as a trusted project management resource and delivery partner • Support business development through scope definition, proposal support, and identifying opportunities to expand client engagements

🎯 Requirements

• Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline required • Minimum of 5 years of project management experience supporting pharmaceutical development or CMC programs for Consultant Level • Minimum of 8 years of project management experience supporting pharmaceutical development or CMC programs for Senior Consultant Level • Experience managing cross-functional CMC development programs within biotechnology, pharmaceutical, CDMO, or consulting organizations • Demonstrated experience in clinical supplies management, including supply planning, packaging, labeling, inventory management, and clinical trial distribution • Experience managing external vendors and development partners, including CDMOs, CMOs, contract laboratories, and logistics providers • Proficiency with project management tools and software, including Microsoft Project and related planning and reporting applications • Strong understanding of pharmaceutical development and CMC activities across drug substance, drug product, analytical, quality, and regulatory functions • Knowledge of GMP requirements and clinical packaging and labeling regulations for investigational products • Strong project planning, scheduling, budget management, risk management, and organizational skills • Ability to manage multiple projects simultaneously while maintaining high quality and client satisfaction • Excellent verbal and written communication skills • Strong problem-solving, decision-making, and issue-resolution capabilities • Ability to operate independently in a client-facing consulting environment while collaborating with cross-functional teams • Demonstrated ability to build trusted relationships and influence outcomes across internal and external stakeholder groups • Experience supporting regulatory submissions and health authority interactions preferred • Experience working within consulting, fee-for-service, or multi-client environments preferred • Experience with commercial supply chain operations, third-party logistics providers, serialization, and distribution activities preferred • Exposure to small molecules, biologics, and advanced therapies preferred • PMP or equivalent project management certification preferred • Syner-G is unable to sponsor or take over sponsorship of an employment Visa

🏖️ Benefits

• Market competitive base salary • Annual incentive plan • Robust benefit offerings • Generous flexible paid time off program • Company-paid holidays • Flexible working hours • Fully remote work options for most positions • Ability to work “almost anywhere” • Ongoing recognition and career development opportunities • Learning and development support • Financial rewards • Leadership and innovation programs