Sustainability Engineer

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

📋 Description

• Serve as the technical lead for tech transfer and manufacturing processes related to drug substance and drug product formulation, radiolabeling, and fill/finish of small molecule and biologic-based radiopharmaceuticals.

• Evaluate production processes and provide detailed reports. Identify and communicate any gaps, risks, and inefficiencies. Drive the implementation of process enhancements and risk mitigation strategies. Lead manufacturing investigations and conduct root cause analyses.

• Assist in the implementation of cold and hot analytical methods under the guidance of internal QC subject matter experts, ensuring compliance with approved methods, validation standards, and quality expectations.

• Support Regulatory Affairs in product IND and new NDA submissions, assist in inspection readiness, participate in regulatory agency inspections, and offer audit support as necessary.

• Oversee technical collaborations with various CDMOs to deliver technical assistance and achieve critical project milestones.

• Draft and review documents such as SOPs, batch records, protocols, and reports for the production of clinical and/or commercial products.

• Ensure compliance through document creation, review, approval, quality investigations, corrective actions, and change control within a Quality system.

• Adhere to procedures that support the protection of intellectual property.

• Provide primary technical support for ongoing batch manufacturing, serving as the first point of contact for technical inquiries, concerns, and/or escalations.

• Collaborate closely with Quality Assurance to continuously support manufacturing partners.

⛳️ Requirements

• Bachelor’s or Master’s degree in science or engineering with over 7 years of experience in the radiopharmaceutical industry, including GMP; or a PhD in science or engineering with more than 5 years of experience in the radiopharmaceutical or biopharmaceutical industry, including GMP.

• Practical experience with multiple isotopes such as F-18, Lu-177, and I-131.

• Proven leadership and managerial capabilities.

• Experience working collaboratively with a team of internal scientists and engineers, managing external CDMOs to ensure adherence to project timelines and cGMPs, as well as ongoing manufacturing operations.

• Familiarity with radiopharmaceutical manufacturing environments, including knowledge of radiation safety principles, ALARA, and relevant regulatory requirements.

• Proficient in MS Office suite applications (e.g., Excel, Word, Project).

• Experienced in authoring complex technical documents, including but not limited to protocols, reports, SOPs, and quality investigations.

• Background in radiopharmaceutical and process development.

🏝️ Benefits

• Competitive salaries.

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development.