Lead and shape the technical direction of Active Pharmaceutical Ingredient (API) manufacturing across external contract facilities in North America. This role is responsible for building and guiding a high-performing team that ensures robust, compliant, and efficient production of APIs, intermediates, and drug product components. You will provide strategic oversight to external manufacturing partners, aligning technical execution with business goals and regulatory standards.
What You'll Do
- Direct the Technical Operations team supporting API manufacturing at third-party sites, ensuring technical excellence and supply continuity.
- Drive continuous improvement initiatives using operational excellence methodologies to enhance efficiency and reliability.
- Lead process scale-up, optimization, and validation activities at contract manufacturing organizations (CMOs), including readiness for regulatory inspections.
- Develop and implement control strategies for new products, ensuring appropriate technical oversight during commercialization.
- Build a proactive monitoring culture to detect and resolve manufacturing deviations early.
- Collaborate with Supply Chain, Quality, and Business Development to manage sourcing, risk, and new product introductions.
- Strengthen technical capabilities across internal and external teams through training, knowledge sharing, and innovation.
- Establish a responsive, cross-functional network for rapid resolution of complex technical challenges.
- Support the integration of emerging technologies and modern manufacturing approaches into existing processes.
Requirements
- Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related field with at least 10 years of relevant industry experience; Master’s with 7 years or PhD with 5 years also accepted.
- Proven leadership in Technical Operations, Process Development, Manufacturing, or Quality within the pharmaceutical sector.
- Experience resolving complex technical issues affecting supply chain stability.
- Background in traditional API processing and demonstrated ability to implement new manufacturing technologies.
- Understanding of validation protocols, process performance qualification, and continued process verification.
- Willingness to travel up to 25%, primarily within North America.
Preferred Qualifications
- Exposure to biocatalysts and enzyme-based manufacturing processes.
- Experience with flow chemistry applications in pharmaceutical production.
- Familiarity with handling highly potent compounds.
- Knowledge of sterile or low bioburden drug substance manufacturing environments.
Benefits
- Eligible for annual performance bonus and long-term incentive programs.
- Comprehensive medical, dental, and vision coverage for employee and dependents.
- Retirement savings plan with 401(k) options and company match.
- Paid time off including vacation, sick leave, compassionate leave, and public holidays.
- Hybrid work arrangement: three days per week on-site, Friday remote unless business needs require otherwise.
