Product Manager, Biomanufacturing
3 months ago
Scismic is supporting the growth of a biotech startup in Cambridge, MA that is building an advanced biomanufacturing technology to scale production of personalized regenerative medicines, with a unique focus on autologous iPSC-based therapies.
The product team's goals are to advance the field of autologous iSPC-based cell therapies through internal and external efforts. The role of Product Manager, Biomanufacturing will play a critical role on the product team, and report to the Chief Product Officer.
Responsibilities
- Guide the development of the company's advanced biomanufacturing technology. Use a strong understanding of the needs of various therapeutic programs and manufacturing processes to iteratively guide the development of the company's advanced biomanufacturing technology capabilities, with an emphasis on enabling scalable production.
- Collaborate cross-functionally with engineering, software, automation, and bioprocess teams to define technology and product requirements based on a deep understanding of the company's strategic goals and the needs of the autologous iPSC-based cell therapy space.
- Maintain a strong understanding of the constantly-evolving regulatory landscape and use this understanding to guide decision-making with regards to the company's biomanufacturing technology and therapeutic program development plans. Use understanding of regulatory requirements to guide data collection and storage practices.
- Monitor industry trends and maintain knowledge of the competitive landscape. Use trends, advancements in the field, and awareness of competitive and complementary technologies and approaches to identify opportunities and guide technology development and application decisions.
- Develop and maintain product documentation, including specifications and version notes.
- Support the development of the company's manufacturing strategy, including prioritization of manufacturing capacity and modeling capacity, throughput, and cost-of-goods.
- Maintain relationships with key stakeholders, including key opinion leaders, cell therapy developers, healthcare professionals, regulators, and scientific advisors. Use the collective knowledge of the company's ecosystem to advance their technology and program development.
Requirements
- Advanced degree (Ph.D. preferred) in a relevant field such as biology, physics, or engineering. Multidisciplinary degree or experience (ie. bioengineering) strongly preferred.
- 3+ years hands-on experience medical device engineering and/or product management.
- Exceptional communication and interpersonal skills; ability to communicate clearly across a range of disciplines; proficiency presenting complex information and analyses at multiple levels.
- Strong analytical and problem-solving skills.
- Highly adaptable and self-motivated; ability to work in a fast-paced, multidisciplinary environment.
- Self-motivated and passionate about the potential for personalized regenerative medicine.
Preferred Skills and Background
- Knowledge of personalized regenerative medicine ecosystem ideal
- Experience in product management
- Understanding of cell therapy manufacturing processes and challenges
- Understanding of regulatory requirements for cell therapy manufacturing and GMP processes is a plus
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