Sr QC Specialist
We are looking for a Senior QC Specialist to strengthen our QC team!
The Senior QC Specialist owns the qualification, validation and implementation of new assays for QC testing and is responsible for the existing portfolio QC assays to ensure that they remain in a qualified/validated state.
In this role you are responsible for data integrity management of the QC assays, for designing the stability study and for the stability protocol- and reports.
Within HALIX, you will be the Subject Matter Expert in regard to assay qualification, assay validation and stability study design in different stages of the product life cycle.
Furthermore you will work closely together with both internal and external stakeholders to scope and define the specific deliverables regarding the assays and the stability study. You work also closely with QA and the QP to ensure data integrity and assay compliance for all QC assays.
Your tasks
- Ensure adherence to all relevant (bio) safety procedures, guidelines and regulations within the QC Analytics team and the QC lab areas
- Provide functional people management of all QC Technicians in the Analytics team (e.g. through technical coaching, training, broad oversight).
- Ensure all QC assay verification/qualification/validation and stability study related activities are performed in accordance with EU GMP, ICH and FDA procedures, guidelines and regulations.
- Ensure adherence to relevant guidelines and regulations in regards to the QC lab area and the QC equipment park.
- First point of contact for Business Development in scoping the work packages for QC assay verification/qualification/validation and stability study design in the proposals.
- Providing guidance to the internal and external stakeholders (e.g. customers) on the requirements for assay verification/qualification/validation in the different stages of the product lifecycle.
- First point of contact for Customers for all activities in relation to QC assay verification/qualification/validation and stability study design and performance.
- Ensure internal QC assay portfolio remains in line with guidelines and regulations (e.g. changes in compendia).
- Ensuring all QC project deliverables in regards to QC assay verification/qualification/validation and stability study design and performance are met in accordance with project timelines.
- Ownership of reference standards and critical reagenets
- Ownership of storage of reference and retain samples in accordance with relevant guidelines and regulations.
- First point of contact for customer audit and authority inspections regarding QC assay verification/qualification/validation and stability study design and performance.
- Ensure data trending is performed in accordance with guidelines and regulations.
You have
- Msc or PhD Degree in the field of life sciences.
- 5+ years of experience in QC assay development and verification/qualification/validation in a pharmaceutical biotechnology company, preferably a CDMO.
- Proven experience in implementing relevant guidelines and regulations towards assay development and assay verification/qualification/validation.
- Proven experience in communicating with external stakeholders (e.g. customers, authorities).
- Strong grasp of English, both verbal and written. Dutch advantageous.
Who are we looking for?
We are looking for an accountable, customer focused and cooperative attitude with a passion for QC.
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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