Scientist Product Analytical Development

---

Job description

*Scientist Product Analytical Development*

Our client is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

*Purpose of the role*
The Scientist Analytical Development will be part of the Product Analytical Development (PAD) group. The Scientist will focus on experimental planning and setting timelines within a project, scientific review and giving scientific input in assay design, development, qualification, troubleshooting and transfer as well as product characterization and early reference studies the scientist will be a bridge between departments. The core tasks will be focused on project specific tasks, like designing, executing, and reporting experimental campaigns, supporting others to consistently deliver high quality analytical methods and studies according to milestones across therapeutic programs.

*Place in the Organization*
The PAD Group is embedded within the Analytical Development department, which also consists of Bio-Analytical Development (BioAD), and Drug Product Development (DPD). The Scientist will be a contributor to the activities of PAD group with a specific attention toward the critical activities of the PAD group:
* Developing, qualifying and transfer of product-specific assays to be used for release testing, stability testing, and extended characterization.
* Providing analytical support to DPD and PD (Process Development) activities by ensuring consistent and timely execution of standardized platform product characterization assays, including data review, storage, and trending.
* Integrating new program products into analytical platforms, to ensure timely progress of transfer and regulatory filing efforts.
The Scientist reports to the Analytical Development Senior Scientist /Team Lead.

*Key result areas (major duties, accountabilities, and responsibilities) *

* Design experimental plans underlining development, qualification, transfer and troubleshooting of assays, introduction of new analytical technologies, or relevant to CMC activities or regulatory filing (e.g., extended characterization, early ref materials, etc.).
* Plans and executes experiments and prepare data overviews and reports, including interpretation of results. Propose next steps in experimental design including rationale and timelines.
* Drafts and reviews laboratory and technical documentation relevant to assay execution (Electronic Lab Notes, SOPs), assay development, qualification, transfer, troubleshooting or other PAD relevant studies (protocols, reports, position papers and memos)
* Coordinates activities to be executed by the team and with help of other teams (AD Lexington, QC, PD), support within the team, assist team members with their planning and coordination of daily activities.
* Communicates and aligns with internal and external stakeholders including CMC on PAD activities relevant to specific projects planning and progression.
* Train technicians, QC analysts or other players as part of the technology transfer and qualification activities
* Responsible for multiple development, qualification, and transfer activities in one or more projects (including execution and writing protocols and reports)
* Ensure all laboratory activities are performed according to applicable protocols and follow safety and quality procedures to ensure a safe working environment and high data quality.
* Improvement of skills and knowledge necessary to successfully support assigned tasks and projects through training and independently. Continuously improve and update her/his area of expertise.
* Provide improvement suggestions and support the improvement implementation.
*Qualifications & Skills*

* Minimum of MSc with 6-8 years of experience or PhD with 2-4 years' experience in a Life Sciences-related field (biochemistry, molecular biology, biotechnology)
* Extensive scientific knowledge and hands-on experience with aseptic cell culture techniques (e.g., insect and human cells)
* Extensive scientific knowledge and hands-on experience with relevant molecular biology techniques (e.g. (q)PCR, DNA electrophoresis)
* Extensive scientific knowledge and hands-on experience with biochemical analyses (e.g., protein electrophoresis, western blotting, ELISA)
* Experience in assay design, assay development and trouble shooting.
* Strong experience in setting timelines within a project planning, alignment and helping others to meet timelines.
* Experience in product characterization studies is a plus.
* Experience in viral vaccines or gene therapy is a plus.
* Working experience in a regulated setting (GxP), technical documentation writing (SOP, Protocols, Reports), and awareness of GxP pharmaceutical regulations
* Computer software skills including Microsoft Office.
* Strong interpersonal and communication skills in English, written and verbal including presentation of technically complex data.
*Core competencies*

* *Detail oriented:* strong analytical skills, strong understanding of assay principles, ability to critically analyse and present complex data sets.
* *Thorough:* ability to set up and carry out tasks with an eye for completeness (e.g., results achieved according to self-prepared protocols, results compiled in clear overview and proposal including timelines for follow up experiments)
* *Analytical Thinking and Problem Solving:* signals problems, recognizes important information, traces possible causes of problems, thinks about, and implements new working methods or new applications, brings forward and implements original solutions for problems related to the department and function helps others in signalling problems and implementing solutions.
* *Planning and organizing:* Strong ability to plan own and other's work to achieve results in a timely way while ensuring the highest standard of quality, discuss within the team and with external stakeholders to align planning of multiple complex activities simultaneously*, *scheduling activities with technicians within the team and help team members with their planning.
* *Co-operative:* ability and drive to work within an interdisciplinary (project) team, good written and spoken communication skills, ability to communicate and align with internal stakeholders and CMC team, ability, and willingness to work in a fast-paced environment. Self-aware.
* *Soft Skills:* dependable, proactive, motivated, flexible