Biomanufacturing Technology Development Manager

5 days ago

Cambridge, Massachusetts, United States Scismic Inc Full time

Job Title: Product Manager, Biomanufacturing

Job Summary:

Scismic Inc is seeking a highly skilled Product Manager, Biomanufacturing to join their team in Cambridge, MA. The successful candidate will play a critical role in advancing the field of autologous iPSC-based cell therapies through internal and external efforts.

Key Responsibilities:

  • Guide the development of Scismic's advanced biomanufacturing technology, leveraging a strong understanding of therapeutic programs and manufacturing processes.
  • Collaborate with cross-functional teams to define technology and product requirements, ensuring alignment with strategic goals and the needs of the autologous iPSC-based cell therapy space.
  • Maintain a deep understanding of the regulatory landscape and use this knowledge to inform decision-making regarding biomanufacturing technology and therapeutic program development plans.
  • Monitor industry trends and maintain knowledge of the competitive landscape, identifying opportunities to guide technology development and application decisions.
  • Develop and maintain product documentation, including specifications and version notes.
  • Support the development of Scismic'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.

Requirements:

  • Advanced degree (Ph.D. preferred) in a relevant field such as biology, physics, or engineering.
  • 3+ years hands-on experience in medical device engineering and/or product management.
  • Exceptional communication and interpersonal skills, with the ability to communicate clearly across a range of disciplines.
  • Strong analytical and problem-solving skills.
  • Highly adaptable and self-motivated, with the 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 the personalized regenerative medicine ecosystem is ideal.
  • Experience in product management is highly valued.
  • Understanding of cell therapy manufacturing processes and challenges is a plus.
  • Understanding of regulatory requirements for cell therapy manufacturing and GMP processes is a plus.

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