QC RESEARCH ASSOCIATE
QC RESEARCH ASSOCIATE
Industriepark Zwijnaarde 7C, Zwijnaarde, Belgium
contract of indefinite duration
Precigen ActoBio is seeking a QC Research Associate to play a key role in the QC Team. This position will be primarily responsible to support the QC team with the planning and execution QC testing of samples from our unique drug delivery platform across a number of different indications.
DUTIES AND RESPONSIBILITIES:
Perform characterization testing of Investigational Medicinal Products (IMPs) or other products in development:
QC testing at release and stability studies;
Routine analyses include but are not limited to microbiological plating techniques, ELISA, Karl Fischer, disintegration testing and bioassay;
Perform and coordinate real-time and accelerated stability studies;
Assist in the development and validation of analytical methods and adapt to standardized methods;
Preparation and quality control of stock solutions, buffers and growth media;
Stock management of chemicals, materials & disposables and follow-up of deliveries;
Perform and record all laboratory weekly or regular checks, such as maintenance and calibration of equipment.
Support in Quality Management System:
Assist in writing deviations, investigations, CAPA, Change Controls and OOS;
Writing and review of SOPs and ensure compliance with SOPs, including temporary revisions to make the systems more efficient and effective;
Assistance in writing and review of validation plans and reports;
Meet identified goals and objectives;
Guarantee good documentation practices.
Development/optimization of fermentation processes: starting up and running of the fermentations and analysis of in process control and end of fermentation samples: microbiological plating techniques, ELISA, sugar content, bile resistance;
The QC Research Associate will report to QC Manager
EDUCATION AND EXPERIENCE:
Bachelor’s in Biomedical, Biochemistry, Pharmaceutical Laboratory Techniques, Industrial Engineering Biochemistry/Biotechnology or equivalent through experience.
Experience in the following domains is an asset:
Microbiological plating methods;
DESIRED KEY COMPETENCIES:
Accuracy and detailed reporting is a must.
Experience in a cGMP environment/setting & Quality Assurance is an asset.
Excellent understanding of MS Office (Excel, Word, PowerPoint, Outlook).
Sense for initiative, dynamic, flexible and creative.
Good communication and reporting skills and proficient in Dutch and English.
Maintain a high degree of ethical standard and trustworthiness.
Capable of fostering change and innovation in an organization.
Ability to think and adapt to a rapidly changing environment and demands.
Able to reach rational conclusions through complex processing of information.
Effective organization and implementation of group projects.
Capable of high performance in independent work as well as in team setting.
Ability to follow and apply Regulatory and cGMP requirements.
Ability to author technical documents using Precigen ActoBio’s templates.
Ability to meet timelines in all assigned projects and acclimate to changing priorities.
Ability to follow, review and revise SOPs.
Ability to work in a collaborative team environment.
Ability to recognize and communicate simple and complex problems with relevant team members, department management and cross-functional peers.
Precigen ActoBio™ is a clinical stage biotechnology company pioneering a new class of therapeutic agents created on the ActoBiotics™ platform. These are targeted, microbe-based, specifically designed agents that express and locally deliver potential disease-modifying therapeutics at disease sites including the intestine, the mouth and the nasopharynx, to treat a range of disorders. We have a strong R&D pipeline and an extensive portfolio of candidates advancing toward clinical development across a number of potential indications.
Precigen ActoBio™ is a wholly-owned subsidiary of Precigen. (Nasdaq: PGEN)
We invite you to discover more at Precigen ActoBio.
Recruiting Contact: Inge Vandenhove: email@example.com