Digital CMC Consultant (Life Sciences)
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Digital CMC Consultant (Life Sciences) based in the United States.
This role sits at the intersection of life sciences innovation and digital transformation, focusing on how Chemistry, Manufacturing and Controls (CMC) processes are modernized through technology and data-driven approaches. You will work closely with pharmaceutical and biotech organizations to translate complex scientific and regulatory requirements into scalable digital solutions that improve speed, quality, and compliance in drug development and manufacturing. The environment is highly collaborative and client-facing, involving senior stakeholders across R&D, QA, regulatory, and manufacturing functions. You will play a key role in shaping transformation strategies and guiding organizations as they move from legacy systems to modern digital CMC frameworks. This is a hands-on consulting role where delivery excellence, analytical thinking, and cross-functional communication are critical. The work directly contributes to accelerating the development of life-changing therapies in a highly regulated global industry.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Digital CMC Consultant (Life Sciences) based in the United States.
This role sits at the intersection of life sciences innovation and digital transformation, focusing on how Chemistry, Manufacturing and Controls (CMC) processes are modernized through technology and data-driven approaches. You will work closely with pharmaceutical and biotech organizations to translate complex scientific and regulatory requirements into scalable digital solutions that improve speed, quality, and compliance in drug development and manufacturing. The environment is highly collaborative and client-facing, involving senior stakeholders across R&D, QA, regulatory, and manufacturing functions. You will play a key role in shaping transformation strategies and guiding organizations as they move from legacy systems to modern digital CMC frameworks. This is a hands-on consulting role where delivery excellence, analytical thinking, and cross-functional communication are critical. The work directly contributes to accelerating the development of life-changing therapies in a highly regulated global industry.
Accountabilities:
- Lead and deliver complex Digital CMC workstreams and transformation projects across development and manufacturing environments.
- Analyze business and technical requirements and translate them into clear digital solutions aligned with client objectives and regulatory expectations.
- Support end-to-end project execution while ensuring quality delivery, stakeholder alignment, and measurable client outcomes.
- Advise clients on best practices in CMC, QA, and regulatory processes while supporting the shift toward digital and automated workflows.
- Collaborate with executive stakeholders to define scope, align on transformation goals, and secure buy-in for proposed solutions.
- Act as a liaison between clients and internal product and engineering teams to ensure accurate requirements capture and solution alignment.
- Bachelor’s degree in life sciences, engineering, business, or a related field, or equivalent professional experience.
- 10+ years of experience in life sciences, consulting, or software delivery within regulated environments.
- Strong domain expertise in pharma CMC, QA, regulatory affairs, or GMP manufacturing workflows such as validation, tech transfer, or supply chain.
- Proven experience in customer-facing consulting roles, including managing senior and executive-level stakeholders.
- Strong analytical, problem-solving, and structured thinking capabilities.
- Experience working with global pharmaceutical or biotech organizations is highly desirable.
- Willingness and ability to travel up to 30% as required.
- Competitive compensation package including salary, equity, and performance-based bonuses.
- Flexible work arrangements with hybrid and remote options depending on location.
- Unlimited PTO and family-friendly policies designed to support work-life balance.
- Strong learning and development culture with ongoing training and professional growth opportunities.
- Stipends and support for professional development and role-related success.
- Commuter benefits available in select locations, including Dublin, supporting sustainable travel options.
- Inclusive, global work environment with opportunities to collaborate across international teams.