Production Manager
Are you an experienced Production/Manufacturing Manager looking to make your mark at a fast growing CDMO? Then read further and join us as Production Manager!
The Production Manager is responsible for the production department including the technology transfer of production processes for protein and viral products from development or from the customer to GMP. In case of routine production, the Production Manager will build the production team to meet the demand. You ensure an effective cooperation with the facilities, project management and the quality teams to ensure the Master Production Schedule is met.
Your tasks
Responsible for maintaining a safe working environment and drive zero incidents in the production department
Responsible for coaching of direct reports and ensuring processes in place to support adequate people management. You will build the production team capabilities to ensure current and future customer requirements are met as effectively and efficiently as possible.
Responsible for the EU GMP/FDA compliance of the production equipment, facilities and the production quality management system
Responsible for meeting the Master Production Schedule. Accurate (resource) planning, execution and reporting of all production and operational activities
Implementation of key performance indicators and continuous improvement programs
Reviewing and providing input into customer proposals for business development activities. Ensure business development and developing additional business with existing customers is a priority in the production organization
Developing plans and proposals for investments in cooperation with senior leadership
Tactical / strategical target setting for the Production department and the HALIX organization as a part of the Management Team
You have
At least an MSc degree in biotechnology, molecular biology, microbiology or in a comparable field.
At least 7 years of experience in a biopharmaceutical production environment, preferably in a CDMO, in which at least 5 years in a people management role. Solid understanding of EU GMP / FDA regulatory requirements
Strong experience in protein, vaccines and viral vector drug substance manufacturing using mammalian cells
Understanding of product lifecycle requirements – early / late stage process development, tox / engineering batch(es), production of clinical trial materials for phase I/II/III, process characterization and process validation
Good knowledge of English, both verbal and written. Dutch is considered as an advantage.
Who are we looking for?
You have a strong technical background; for example in Process Development, MSAT, CMC or Tech Transfer, with sound people management experience. You have an active hands on mentality but are able to think strategically and can convey your plans to senior leadership. As our Production Manager you like to work in a service business in which you communicate with our customers on operational progress, challenges and new business opportunities. You are able to work under time pressure, allocate your time flexibly and manage the Production Department in project-based matrix organization.
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.
.jpg)