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Process Owner, Scientific Affairs at Cellares
South San Francisco, United States
Job Descrption
We are seeking an innovative and highly motivated Process Owner who will contribute significantly to the development and continued growth of our advanced cell therapy manufacturing platform.
The Process Owner will play a pivotal role in driving the successful adoption of our automated Cell Therapy Manufacturing Platform by engaging with partners and clients throughout the product adoption life cycle. The Process Owner will be responsible for establishing strong working relationships, understanding customer needs, and delivering tailored solutions to maximize customer satisfaction and adoption success.
This is a multidisciplinary role responsible for interfacing across many parts of the company (with Process and Analytical Development, MSAT, Product and Alliance Management teams) to develop the best solutions possible.
Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
Responsibilities
- Engage with partners to understand their unique requirements and challenges related to cell therapy manufacturing
- Understand the drug product release specifications and monitor the process translation acceptance criteria throughout development and characterization, ensuring alignment with regulatory requirements and industry standards
- Monitor and evaluate process performance against product specific success criteria, for in-process and final release
- Inform and/or develop plans for process development and analytical development to meet and/or exceed success criteria
- Serve as Subject Matter Expert (SME) of current and upcoming Cellares technology capabilities and performance specifications
- Establish and maintain strong working relationships with partners throughout the life cycle of programs, ensuring smooth communication and successful program outcomes
- Maintain an up-to-date awareness of the current state of cell & gene therapy through continuous monitoring of scientific literature and competitive intelligence
- Contribute to the development of marketing materials and case studies
- Develop strong working relationships with internal subject matter experts across the organization, fostering a collaborative and knowledge-sharing environment
- Drive overall customer satisfaction and engagement to foster lasting partnerships and promote the adoption of Cellares’ Technology Solutions in the industry
Requirements
- B.S. degree in life sciences, biomedical engineering or related discipline required
- 4+ years of experience working in cell & gene therapy drug development and/or commercialization
- 4+ years of experience in client services directly interfacing with partners and/or clients
- Experience working with and building strong relationships with cross-functional departments in Process and Analytical Development, MSAT, Product and Alliance Management, Regulatory and Quality
- Strong problem-solving skills and attention to detail, with the ability to troubleshoot technical issues and propose effective solutions
- Excellent communication and presentation skills, with the ability to effectively convey complex concepts to diverse audiences
- Experience with semi-automated instruments and/or bioprocess automation is a plus
Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.
This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
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