07 September 2022 – Job opportunity Biotech associate at Medace
Medace is a unique service provider in the medical industry. Located in the South of the Netherlands, Medace offers a full service ISO13485 certified and GMP compliant work-learning environment where customers are trained and guided in developing their medical product towards clinical implementation and market introduction. From building the product / technical dossier needed for clinical validation to producing the clinical grade product in our state-of-the-art research and cleanroom facilities. Our clients range from academic groups to corporates, with the main audience being startups active in the field of Medical Devices and cell-based Medicinal Products. This results in a vivid biomedical co-working space where entrepreneurship and science thrive. For more information about our company visit www.medacespace.com.
What are we looking for?
The ideal candidate has previous experience in cell biology/biotechnology in an industrial setting. The candidate is a team player and critical thinker, with the ability to ensure compliance in production meets the required quality standards. You are able to define quality criteria for development and production of medical products (cell-based medicinal products and medical devices) and have strong written and verbal communication skills to provide concise and clear quality documentation and guidance to our clients. You’ll take on the responsibilities for guiding our clients in their production cycle, by training and supporting them in cleanroom behavior, including gowning, cleaning, sampling up to aseptic manufacturing. You have a high level of adaptability and are open to broaden and share your quality expertise in different biomedical product development areas. As Biotech associate, you will also work closely with the GMP Quality and Operations team for initiation and follow-up of deviations, CAPA and changes to maintain and improve Medace’s QMS as well as providing support during internal / external audits.
Biotech Associate responsibilities
- Provides advice, facilitation and training to the multi-disciplinary teams (Clients) in GMP production processes in a cleanroom environment
- Provides hands-on support in GMP production and QC processes (e.g. carrying out aseptic manufacturing procedures, write and review quality documentation, validation of QC protocols)
- Works with the quality and operations team to develop quality control methods, and for initiation and follow-up of deviations, CAPAs and changes
- Help set up and conduct trainings on general cleanroom behavior, quality concepts and tools
- Support the GMP quality and operational team during internal/external audits
Biotech Associate qualifications
- Bachelor’s degree or equivalent experience in cell biology/biotechnology
- 1-2 years of cell- or tissue culturing experience in a GMP environment, preferably within an industrial setting
- Experience with current GMP regulations and quality events (non-conformities, CAPA, change control) in the medical field
- Experience with working under a Quality Management System
- Experience in technical writing, creating and reviewing SOPs, verification and validation protocols
- Acquainted in providing support during audits (internal, external, supplier)
- Basic knowledge of Risk Management processes (FMEA, ISO 14971)
- Hands-on teaching/training skills
- Independent thinking and planning ability
- Initiator, self-propelling and contribute actively to solve problems
- Excellent command of English, spoken and written
- Good communication/presentation skills
- Critical, accurate, and precise
- Team player
- Multitasker with high stress level
- Proactive and service mindset to deliver the highest quality possible
What we offer
Medace offers a challenging job in an inspiring and ambitious young organization. Communication lines are short and personal initiative is highly stimulated and appreciated. We offer a full time position via a one year contract with a possible prospect on a permanent employment. We are committed to support your professional and personal development and give you the opportunity to cooperate with talented people in an informal, transparent and open culture. Working closely with the GMP quality team as well as the operational team at Medace will help develop your skills in this role.
Interested in joining Medace as Biotech Associate?
Please submit your motivation and resume via firstname.lastname@example.org before September 30th.
Acquisition as a result of this vacancy is not appreciated!