Senior Director, Technical Operations

Senior Director, Technical Operations

Looking for an exciting opportunity to lead a position at CCRM Nordic contributing to Sweden’s vision of becoming leader in Advanced Therapy Medicinal Products (ATMPs)?
Consider applying for the Senior Director Technical Operations role at CCRM Nordic.

About CCRM Nordic

CCRM Nordic is a newly established national infrastructure for commercialization of advanced therapy medicinal products (ATMPs). CCRM Nordic is a not-for-profit company based in GoCo Health Innovation City, Mölndal that is establishing process development and GMP ATMP manufacturing capabilities during the coming years. CCRM Nordic vision is to benefit patients by enabling commercialization of advanced therapies.

Position

Senior Director, Technical Operations

CCRM Nordic office at GoCo Health Innovation City Mölndal Gothenburg, Sweden

Full time, 100%

About the role

The Senior Director of Technical Operations oversees the strategic vision, delivery and implementation of manufacturing processes for all advanced therapeutic modalities. This strategic leader drives innovation in technical operations, ensuring scalability, regulatory compliance and efficiency to meet clinical and commercial manufacturing goals are satisfied. The role demands strong technical expertise, proven leadership capabilities and strategic vision to contribute to the growth and success of the ATMP pipeline.
The role will also support the companies BD activities and actively be part of customer project strategies.
As a Senior Director in Technical Operations at CCRM Nordic you report directly to the CTO and you will play a pivotal role in advancing transformative therapies from concept to commercial success, contributing to groundbreaking treatments that address unmet medical needs globally.

Main tasks and responsibilities:

· Support the CTO in developing and leading the overall technical operations strategy for ATMP programs, ensuring alignment with corporate objectives.
· Collaborate with cross-functional teams, including process development, business development, regulatory affairs, quality and manufacturing, to ensure seamless integration of technical development into the product lifecycle.
· Establish and maintain relationships with external partners, including competence centers, sector collaboratives, professional networks, as well as strategic and consortium partners, contract manufacturing organizations, technology providers, and academic institutions.
· Design and optimize processes to produce ATMPs, focusing on scalability, efficiency, and cost-effectiveness.
· Drive innovation by implementing emerging technologies such as automation, PAT, bioreactor advancements, and novel purification methods that enhance the ATMP development process.
· Oversee the development of robust analytical methods to support process characterization and quality control.
· Ensure all processes meet regulatory requirements for clinical trials and commercial production, including cGMP and ICH guidelines.
· Support regulatory submissions by providing comprehensive technical development documentation.
· Oversee the planning and execution of technical development projects, ensuring timelines, budgets, and milestones are met.
· Optimize resource allocation to balance short-term deliverables with long-term innovation goals.

Qualifications/Skills:

· PhD or equivalent in Science (Biology, Chemistry, Engineering) with at least 15 years’ experience.
· Proven track record of leadership in the development and implementation of technology strategies within the biotechnology or pharmaceutical industry, preferably in the field of ATMPs.
· Excellent verbal and written communication skills, including ability to effectively communicate with customers, and present at relevant conferences and events.
· Understanding of ATMP and medical device regulatory requirements.
· Must have strong background of technology application in process development and production of ATMPs.
· Strategic thinking and ability to anticipate industry trends.


Why work at CCRM Nordic

This is an opportunity to make a real impact in the field, shaping the direction of regenerative medicine in the Nordics together with a dedicated enthusiastic team.
You should be based around the Gothenburg region and able to attend our Mölndal office on a regular basis.


Application

Please submit your application as soon as possible to jobs@ccrmnordic.se as interviews will be held continuously as strong applicants are identified. Please label your application with “Senior Director, Technical Operations”.

Closing date: December 20, 2024.