*Scientist for Evening/Nightshift, Quality Control
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Are you eager to join a fast-growing international CDMO organization producing new biological medicines? Are you experienced working In Quality Control and working during evenings and nights? Do you have a can-do attitude and taking ownership of dedicated area of expertise? Then look no further, and come and join our diverse and international team with amazing colleagues.
In QC Bioassay Evening/Nightshift we are looking for a Scientist to take ownership and ensure timely deliverables with method validation studies, stability studies, batch release testing and stop/go support for manufacturing of biopharmaceuticals. As Scientist in QC Bioassay Evening/Nightshift, you will be involved in a broad range of tasks to supporting timely QC deliverables in AGC projects with customers from around the globe. You will join a team of 3 scientists and 6 technicians and report to the Manager of the QC Bioassay Evening/Nightshift team.
About The Department
QC Bioassay Evening/Nightshift is part of the Copenhagen based Quality Control organization, which consists of around 150 dedicated and skilled colleagues divided into five departments (Bioassay, Chemistry, Microbiology, Support and Equipment & Planning). Together, as one department we use our technical expertise when working side by side with customers, to provide innovative solutions to secure timely delivery of reliable and compliant products for patients.
In QC Bioassay, we are a group of dedicated scientists and technicians divided into 3 teams (QC Evening/Nightshift, QC Bioassay and QC Bioassay Cell and Support). In QC Evening/Nightshift team we perform a broad range of tests (e.g. SoloVPE, OD, Osmolality, pH, Appearance, Visual Inspection) and ensure timely review and approval of test results. The team is responsible for diverse tasks such as analytical method validation, batch release testing, stop/go testing and stability testing of phase I/II and phase III/Commercial products (DS/DP), as well as coordination and planning of analytical activities and troubleshooting; All to support our customers.
Roles And Responsibilities
In the vacant scientist position, you will be involved in multiple different tasks all related to ensure timely release testing of product (DS/DP) for our customers. Thus you will be responsible for analytical transfer activities and validations, laboratory investigations, and compliance activities. Your primary responsibilities will be focused on supporting n the QC laboratory during evenings and nights both on weekdays and weekends. As a scientist working in the evening/night you will be part of a team focusing on good collaboration both within the evening/night shift team as well as with your, QC Bioassay colleagues and other stakeholders to achieve goals together.
Your key responsibilities:
- Ensure on-time delivery of results for stop/go testing to support our manufacturing production
- Review and approval of analytical results for stability studies and batch release
- Responsible for method validations according to current ICH guidelines
- Troubleshooting and scientific support on a broad range of analytical methods
- Drive compliance documents related to QC activities, such as deviations, Laboratory investigations and CAPAs
- Involved in coordination and execution of analytical activities in QC Bioassay and across the QC area
- Collaboration with multiple stakeholders, including Analytical Development, Project Managers, Manufacturing and QA
- Ensuring all tasks performed in cGMP compliance
Your Profile
The ideal candidate holds a MSC or PhD degree in Biochemistry, Biology, Engineering or other related field of study, and has preferable experience from the pharmaceutical industry from Quality Control, or Quality Assurance, Production or CMC areas. You enjoy working in a dynamic environment and are able to keep the overview of multiple simultaneous tasks also when priorities are frequently changing.
We expect that you thrive working in a dynamic environment and able to keep the overview of multiple simultaneous tasks also when priorities are frequently changing. Moreover, we expect you bring some of the following characteristics and capabilities:
- Experience with Bioassay and pharmacopeia methods such as SoloVPE, OD280, Osmolality, pH, and Appearance testing
- Experience within testing by Octet is an advantage, but not a requirement,
- A strong analytical mindset and troubleshooting skills
- Structured and detailed-oriented but also demonstrating a pragmatic can-do-attitude
- Hands-on experience with handling laboratory investigations, deviations, change requests and CAPA’s
- The ability to handle multiple tasks simultaneously in a busy environment
- Experience working according to cGMP
- Good collaboration skills and teamwork
- Good communication skills and a service-minded attitude to meet customer requests in a positive and professional way
- Fluency in English is a requirement as English is our corporate language
Application
For further information regarding the position, please contact Manager Abdurrahman Sahan , on +45 27602468 We treat the applications as we receive, and conduct interviews with qualified candidates. Therefore, please submit your application as soon as possible. When the right candidates are found, the add will close.
Want to keep posted about our growth and to learn more about our company?
We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !
AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 9.2.2023, men kan have været deaktiveret og genaktiveret igen.
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