Digital CMC Consultant – Life Sciences

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

📋 Description

• Oversee intricate workstreams and initiatives centered around Digital CMC in both development and manufacturing, facilitating business and technological transformations to enhance the delivery of groundbreaking therapies in life sciences.

• Examine complex business needs to document and execute digital CMC projects, ensuring that all technical specifications align with client-defined business objectives.

• Accountable for the execution and successful delivery of customer projects, offering guidance and best practices while ensuring the overall success of our clients.

• Propel the advancement of Digital CMC thought leadership, assisting clients in shaping their transformation vision and transitioning from outdated processes to a forward-thinking digital enterprise environment.

• Collaborate with senior stakeholders to define project scopes, align on transformational objectives, and secure buy-in for proposed Digital CMC solutions.

• Act as an intermediary between clients and internal Product and Engineering teams to guarantee that customer requirements are accurately captured and understood.

⛳️ Requirements

• Bachelor’s degree in a scientific field, business, or equivalent professional experience.

• Master's in Engineering Management (MEM) or over 10 years of direct experience within life sciences, software, or consulting in regulated industries.

• Preferred background in pharmaceuticals with experience or exposure to CMC, QA, and/or Regulatory affairs.

• Familiarity with one or more workflows that support GMP manufacturing (e.g., supply chain, change management, tech transfer, validation, etc.).

• Strong analytical and problem-solving capabilities.

• Experience collaborating with global pharmaceutical companies.

• Experience in customer-facing consulting roles.

• Managed relationships with executive-level stakeholders.

• Willingness to travel up to 30% of the time.

🏝️ Benefits

• Our people-first approach: Every decision made by the company considers your needs. With unlimited PTO and flexible working hours, we strive to prioritize our employees by allowing them to work (and live!) in a manner that suits them best.

• Culture of learning and development: We believe growth is fundamental to success, and we seek opportunities for it at every turn.

• Competitive compensation package: Retaining exceptional talent involves recognizing their value and compensating them accordingly. Our salaries, equity options, and bonuses reflect the caliber of individuals we hire.

• Family-friendly PTO policies: Our unlimited vacation policy embodies our family-first culture and promotes a healthy work-life balance.

• Hybrid office model: As a virtual company with team members worldwide, you have the flexibility to work from home or choose to go into an office (if located in one of our brick-and-mortar cities – Austin, Boston, and Dublin).

• Commuter benefits (Dublin, Ireland): We support flexible and cost-effective commuting options through applicable commuter benefit programs and pre-tax savings opportunities, including public transportation and eligible cycling-to-work initiatives.

• Stipends: We offer various stipends to our full-time employees to foster professional growth and ensure success in their roles. Enhancing your skills contributes to our collective improvement!