Head of Operations - SmartCella

at  Haeger Carlsson Executive Search Interim AB

Play a vital role in a cutting-edge biotechnology company working on the intersection of therapeutics and medical devices
As SmartCella is set to accelerate customer onboarding in line with the strategic plan, the Head of Operations of the business unit SmartWise will provide strategic operational leadership, supply chain expertise, and technical acumen to successfully develop the global market roll-out for the business.
The Head of Operations role is a critical addition to the Business Unit’s Leadership Team for SmartWise and will report directly to the BU Head and CBO.
To thrive in this role, you should be results-oriented and strategic, with a customer-focused and solutions-oriented approach. You should also possess an entrepreneurial mindset with a can-do attitude and the ability to adapt to change.
About the company: SmartCella is a cutting-edge biotech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with innovative cell and mRNA therapies. The SmartCella group consist of ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 66 employees from more than 20 nationalities.
Read more:
https://www.smartcella.com/
https://www.smartcella.com/smartwise/

QUALIFICATIONS

• Relevant first degree, e.g. engineering or life sciences.
• Experience in managing outsourced manufacturing and in scaling up manufacturing from small scale manual production to large scale mass production including automated / semi-automated production.
• Experience in medical device development and manufacturing, incl. well established understanding of regulatory and quality frameworks, e.g. ISO 13485 and MDR.
• At least 5 years of experience in managing workflows and operations teams (Engineering/ Supply Chain/ Manufacturing.).
• Experience of managing employees, leading, and building teams, as well as comfort in operating in a matrix.
• Fluency in English is mandatory, Swedish highly preferred.
• Merit: Experience working with and implementing ERP systems.
• Experience of working in a small business environment is a plus.
  The role is based at the Swedish headquarters in the south of Stockholm.
  If you are interested in working with new therapeutics and novel products at the forefront of innovation, this is an opportunity you cannot miss. Join SmartWise’s exciting journey and the chance to work with a highly dedicated and passionate team. We are looking forward to your application.

• Responsibility for contract manufacturer-based manufacturing & supply of company’s medical device to customers on time and under quality requirements, within appropriate ISO standards.
• Support the transfer from development to production at the contract manufacturer, manage and plan the serial production of products in line with demand forecasts.
• Responsible for defining and ensuring compliance with the work plan, goals, and objectives (operational performance indicators and KPIs).
• Matrixed employee management throughout the department, including recruitment, training, mentoring, and development of employees as the organization develops.
• Leading and building work processes and procedures, continuous improvement methods, managing suppliers and subcontractors, and negotiating and closing strategic supply agreements.
• Managerial and professional responsibility for the company’s ERP system, incl maintenance and expansion of the system as growing needs arise.