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Consultant I

1 month, 1 week ago
Anywhere
Full-time
Senior
Consultant
Operations
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Syner-G BioPharma

Syner-G BioPharma

Syner G BioPharma Group offers leading CMC & Regulatory Affairs solutions for biopharma, specializing in strategic CMC 360 services, global regulatory affairs, and quality compliance to support successful drug development.

Professional Services
51-250
Founded 2007
View All Jobs 8

Description

  • Develop and manage integrated CMC project plans, timelines, milestones, dependencies, and resource requirements.
  • Coordinate clinical supplies operations, including forecasting, manufacturing scheduling, packaging, labeling, release, distribution, and inventory management.
  • Oversee investigational product packaging and labeling in compliance with GMP, study, and regulatory requirements.
  • Manage project budgets, forecasts, vendor invoices, scope changes, and change orders.
  • Identify, track, mitigate, and escalate risks and issues affecting timelines, quality, or deliverables.
  • Coordinate cross-functional teams and external partners, including CDMOs, CMOs, laboratories, and logistics providers.
  • Facilitate project meetings, governance reviews, and client status meetings while documenting decisions and action items.
  • Prepare project status reports, dashboards, milestone reviews, and stakeholder communications.
  • Build client relationships and serve as a trusted project management and delivery resource.
  • Support business development through scope definition, proposal preparation, and identifying engagement expansion opportunities.

Requirements

  • Bachelor’s degree in life sciences, chemistry, biology, engineering, pharmaceutical sciences, or a related scientific field.
  • Minimum 5 years of project management experience supporting pharmaceutical development or CMC programs; 8 years for Senior Consultant level.
  • Experience managing cross-functional CMC programs in biotechnology, pharmaceutical, CDMO, or consulting organizations.
  • Experience with clinical supplies management, including supply planning, packaging, labeling, inventory, and clinical trial distribution.
  • Experience managing CDMOs, CMOs, contract laboratories, logistics providers, and other external partners.
  • Proficiency with Microsoft Project and related project planning and reporting tools.
  • Strong knowledge of pharmaceutical development, CMC functions, GMP requirements, and clinical packaging and labeling regulations.
  • Ability to manage multiple projects, budgets, schedules, risks, and stakeholders in a client-facing environment.
  • Excellent communication, problem-solving, decision-making, organizational, and relationship-building skills.
  • Advanced degree, regulatory submission experience, consulting or multi-client experience, commercial supply chain knowledge, multiple therapeutic modality experience, and PMP certification are preferred.

Benefits

  • Market-competitive base salary and annual incentive plan.
  • Robust benefits package.
  • Flexible paid time off and company-paid holidays.
  • Flexible working hours and fully remote work options for most positions.
  • Ability to work almost anywhere, with offices in Greater Boston, San Diego, Boulder, and India.
  • Career development, ongoing learning, and employee recognition programs.

Interested in this position?

Apply directly on the company website

Apply Now

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