Associate Director Manufacturing Science & Technology
The Associate Director MSAT is responsible for the MSAT Department and will report to the VP Operations. This role is dynamic and involves a balance between technical expertise and management skills overseeing and supporting the integration of scientific, technical, and operational activities to ensure efficient manufacturing processes and quality outcomes for clients.
This will require collaboration with other departments, working closely together with QA, maintenance, validation, engineering & facilities, Supply Chain and project management, to ensure high-quality, cost-effective, and timely production of biotech products, with a strong focus on compliance and optimization.
Your tasks
- Align with business goals while maintaining the highest standards of quality, safety and efficiency
Lead and contribute to the development, scale-up, transfer and optimization of biotechnological manufacturing processes. - Oversee the technology transfer of processes and technologies from development to GMP (full scale) manufacturing, ensuring that all activities are aligned with regulatory requirements and client specifications.
- Serve as the primary technical point of contact for project teams and clients during the techtransfer and manufacturing, addressing client concerns and providing timely updates.
- Provide technical guidance during process development and manufacturing activities.
- Identify process or equipment-related issues, developing and implementing corrective actions to improve product yield, quality, and efficiency.
- Lead and mentor a team of MSAT professionals, fostering a culture of collaboration, continuous improvement, and technical excellence.
- Work closely with Quality Assurance (QA), Quality Control (QC), Engineering/Validation, and Production teams to ensure alignment and smooth execution of manufacturing activities.
- Ensure that all activities are documented in compliance with Good Manufacturing Practices (GMP), FDA, EMA, and other applicable regulatory requirements incl. review of batch records, SOPs, and technical documentation.
- Drive process improvements, implementing new technologies and methodologies to optimize manufacturing efficiency, quality, and cost-effectiveness.
You have
- MSc/PhD degree in a relevant field (e.g., engineering, biotechnology).
- At least 7 years of experience in working in a comparable role in a biopharmaceutical company with sound knowledge of GMP USP/DSP processes and technology transfer and process development.
- Proven leadership and team management experience.
- Excellent analytical and problem-solving abilities, solid understanding of regulatory requirements and quality management systems; knowledge of Lean Six Sigma tools and methodologies is advantageous.
- Strong communication and interpersonal skills.
- Good command of the English and language, both verbally as in writing. Dutch is advantageous.
- Ability to work collaboratively across departments and drive change.
Who are we looking for?
- Professional self-development
- Result oriented
- Accountability
- Cooperation
- Customer focus
- Planning & organizing
- Analytical thinking
Our offer
- You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
- A culture that is characterized by entrepreneurial spirit and close and transparent communication. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
- You will be working in our dynamic headquarters in Leiden.
- Being part of a company that is focused on excellence in GMP Manufacturing.
- A competitive salary that matches your responsibilities and experience.
Your application
We look forward to hearing from you! We are interested in your CV, but we also want to find out more about your ambitions, your personality and what drives you to apply. So be sure to include a brief cover letter telling us why you are a match for this position. The application process consists of an introduction by the Recruiter, two interviews either via video call or live at our office in Leiden with the Hiring Manager and/or a Department Specialist followed by contract negotiations. Depending on the vacancy, an assessment could be part of the process.
Important notice to search firms and recruitment agencies
HALIX does not accept unsolicited approaches from recruitment agencies and/or search firms (such as, for instance, the sending of resumes) for any job posted on this or a referring website. All recruitment agencies and search firms are required to contact HALIX Recruitment via recruitment@hal-allergy.com to enquire about a potential recruitment or search agreement with HALIX.
HALIX, Bioscience as a Service
HALIX is a fast growing, biopharmaceutical contract development and manufacturing organization (CDMO) focused on viral vector and recombinant protein products. We support our customers with the development & commercialization of biologics enabling the treatment & prevention of life threatening conditions such as cancer, COVID-19, influenza and other infectious diseases. Our state of the art GMP manufacturing facilities and our experienced and dedicated team of people ensures manufacturing capabilities which meet the highest quality standards, a service oriented way of working and a flexible mindset. If you too would like to become part of an innovative and challenging contract development and manufacturing organization (CDMO), then this is a perfect opportunity!
HALIX is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HALIX is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.
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