Pharmaceutical Operations/Product Launch Lead

Position Overview
We are seeking a strategic and entrepreneurial Pharmaceutical Operations Lead to spearhead Product Launch and Strategic Initiatives within our fast-growing healthcare technology company. This role is pivotal in driving product launches, scaling pharmaceutical and laboratory operations, and leading high-impact partnerships-all in close collaboration with our Co-Founder/Medical Director.

Key Responsibilities

• Develop and execute product strategies that align with regulatory requirements and company growth objectives.
• Ensure compliance and quality assurance, maintaining adherence to FDA regulations and industry standards.
• Manage FDA filings (NDA, ANDA, 505(b)(2)) and oversee international drug approval processes.
• Lead cross-functional teams to optimize project execution and enhance operational efficiency across the product lifecycle.
• Oversee budget planning and monitoring for product development, ensuring financial responsibility and strategic allocation of resources.
• Drive stakeholder engagement, ensuring product strategies align with market needs and business goals.
• Apply Lean Six Sigma methodologies to identify and implement process improvements that maximize operational excellence.
• Develop and manage relationships with Contract Development and Manufacturing Organizations (CDMOs) to strengthen product development and supply chain efficiency.
• Oversee clinical trial operations, ensuring timely execution and regulatory compliance.
• Implement risk management strategies to proactively identify, assess, and mitigate operational and regulatory risks.
• Lead team development and training to enhance strategic planning, execution, and project management capabilities.
• Collaborate closely with R&D, Regulatory Affairs, Marketing, Engineering, and Operations teams to optimize product launch success.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or a related field; a Master's degree or MBA is preferred.
• 5+ years of experience in pharmaceutical operations or product strategy, with a proven track record in leadership roles.
• Strong entrepreneurial background, especially in pharmaceutical product launches and business expansion.
• In-depth expertise in compliance, quality assurance, and regulatory affairs within the pharmaceutical industry.
• Hands-on experience with FDA filings and international drug approvals.
• Demonstrated leadership in scaling pharmacies, laboratories, and pharmaceutical product lines.
• Experience in e-commerce or tech-enabled healthcare businesses is a plus.
• Comprehensive understanding of pharmaceutical equipment, processes, and regulatory frameworks.
• Proven ability to manage complex project execution, budgeting, and stakeholder coordination.
• Skilled in cross-functional team leadership and collaboration.
• Expertise in process improvement and operational excellence, with Lean Six Sigma certification being a plus.
• Strong background in supply chain management and clinical trial operations.
• Exceptional communication and interpersonal skills, with the ability to influence, motivate, and align teams toward strategic goals.

Benefits

• Highly competitive compensation package ($150-200k DOE)
• Opportunity to lead from within, rapidly scaling leader in the Pharma space
• Growth-minded company culture and highly collaborative environment, tons of growth potential
• 100% company paid Medical, dental, vision coverage, plus Short Disability Insurance and Life Insurance
• 401(k) company match
• PTO and Company Holidays
• Make a tangible impact in an exciting, fast-paced environment

For this position you must be currently authorized to work in the United States. We do not sponsor for this position.