Cerus Corporation is seeking a highly motivated and energetic Scientist with Drug Substance and Drug Product experience to join our CMC team. The successful candidate will play an integral part in strategic planning, coordination, and execution of drug substance and drug product development and commercialization activities as part of a multi-disciplinary team incorporating internal Cerus functions and contract manufacturing partners. The Scientist will be responsible for oversight of contract manufacturing partners (CMOs) for process development, including associated scale-up, process optimization, troubleshooting, technology transfer, manufacturing, and validation activities. This position will work in a collaborative environment to ensure manufacturing timelines are met, and the candidate must have a thorough understanding of major manufacturing processes and technical understanding of equipment used both liquid and solid dosage filling into a variety of container closure systems (glass vials, syringes, flexible plastic containers). Experience with sterilization techniques, especially terminal sterilization is a plus. The successful candidate must be able to clearly communicate complex technical data and principles to a wide variety of technical and non-technical audiences through oral presentations and written summaries. Previous experience in process validations and regulatory submissions for late-stage product is preferred.
- Senior-level individual contributor responsible for supporting drug substance and drug product manufacturing activities for Cerus’ Class III medical devices
- Develop technically sound protocols, reports, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliers
- Work with external contract manufacturers andtest laboratories for all process development, manufacturing, validation activities
- Responsible for ensuring compliance with global regulatory requirements and standards and work with Cerus Quality and Regulatory personnel
- Analyze, interpret results from process development activities and devise pathway for scale up for API and drug product as necessary
- Work with internal and external stakeholders to drive OOS and CAPA investigations to conclusion
- Author protocols and reportsas necessary for all development and validation reports and summaries of manufacturing campaigns for Cerus products
- Author/contribute to regulatory submissions and responses related to CMC amendments, annual reports and new filing for Cerus products. Include regulatory submissions for US, Europe, and rest-of-world.
- Participate on CMC team and cross-functional project teams as needed.
- PhD in a scientific discipline (pharmaceutical science, chemical engineering, or chemistry) with a minimum of 2 years’ experience in a development environment, M.S. with 10 years or exceptional B.S. candidates with a minimum of 13 years relevant experience will also be considered.
- Demonstrated technical project leadership skills.
- Strong understanding of drug substance and drug product manufacturing and global regulatory guidelines.
- Effective project management skills and in working on multiple projects simultaneously.
- Experience in process development and characterization; experience with both development and commercial products is a plus.
- Ability to troubleshoot complex technical issues with the manufacturing process and equipment.
- Experience in cGMP manufacture of parenteral drug products using aseptic technics or terminal sterilization.
- Experience in working with contract manufacturers (CMOs) to carry out technology transfer activities within defined budget and timelines
- Work with CMOs to organize and execute manufacturing schedules that meet the company plan and objectives.
- Experience with resolving process deviations and successfully closing out related investigations
- Experience with CAPA and Change Control
- Strong oral and written communication skills and interpersonal skills.
- Proficiency in all aspects of Microsoft Office (Excel, Word, PowerPoint, Project etc.) and Minitab
- Excellent communication skills including the ability to write technical reports and CMC sections for regulatory submissions.
- Ability to work independently
- Ability to work in a fast-paced, dynamic, environment.
- Up to 25% travel domestically and internationally.