Design and Development Program Manager

Summary

Join CellCarta, a Contract Research Organization, as a Design & Development (D&D) Program Manager. You will lead and oversee projects, collaborating with internal and external teams to ensure timely delivery. This role requires managing high-profile assay projects, overseeing timelines and resources, and conducting risk assessments. You will enhance efficiency by refining operational frameworks and optimizing processes. The position demands strong communication, organizational, and problem-solving skills. The ideal candidate will have a Master's degree in a relevant science field and 6+ years of project management or related experience.

Requirements

• A Master's degree in Sciences, Biomedical Sciences, Pharmaceutical Sciences, Medical Biology, Medicine, or equivalent expertise gained through experience
• 6+ years of project management, and/or CRA (Clinical Research Associate) experience, or a background in genomics or histopathology laboratories
• A strong curiosity and eagerness to learn, coupled with a humble and teachable attitude
• Proven track record of successfully managing (complex) projects to completion with excellent feedback, and the ability to prioritize multiple opportunities effectively
• Exceptional communication skills, fluent in English, with the ability to write clearly and present ideas persuasively
• Proficient in Microsoft Office (Word, Excel, PowerPoint, PowerBI)
• Excellent organizational skills with the ability to multitask
• Positive, energetic, and proactive attitude
• Able to take initiative, adapt, and thrive in a dynamic environment
• Detail-oriented with strong diligence
• Capable of working both independently and as part of a team
• Strong critical thinking and problem-solving skills
• Customer and project management service-oriented
• A solution-focused mindset with a persistent, can-do attitude

Responsibilities

• Lead a cross-functional team by actively engaging and aligning stakeholders to ensure successful assay development, deployment, and submissions that meet customer objectives
• Take responsibility for managing high-profile assay D&D projects, carefully overseeing timelines and resources to ensure on-time delivery. Develop and communicate a long-term vision, while regularly conducting risk assessments to identify and address potential challenges. Proactively manage the assay, anticipate risks, and communicate them to the customer, offering alternative solutions when obstacles arise
• Enhance efficiency and productivity by refining operational frameworks and optimizing processes. Conduct thorough evaluations to eliminate waste and continuously seek opportunities for improvement and innovation
• Ensure all essential documents for internal and external submissions are prepared and managed to achieve timely assay readiness
• Oversee study budget control
• Maintain clear and professional communication with the sponsor, cross-functional project teams, and management throughout the study
• Lead sponsor calls and meetings

Preferred Qualifications

• Experience with ISO13485
• Background in cancer research, with an understanding of clinical laboratory operations, assay/instrument principles related to in vitro diagnostic product design and usage, and the scientific, statistical, regulatory, and compliance requirements of clinical research
• Experience working in CAP, CLIA, and GCP environments, with a solid understanding of EMA and/or FDA guidelines for clinical trials
• Experience working in global settings

Benefits

• A competitive salary and comprehensive benefits package
• A dynamic, fast-paced global environment that fosters personal growth
• Opportunities for training and development in both technical and interpersonal skills
• Career advancement as the company experiences rapid growth
• A healthy work-life balance with options for both onsite and remote work
• A progressive company well-prepared for the future
• A supportive and talented team to collaborate with