Client is dedicated to bring innovative therapies or unmet medical needs to patients. In doing so each function in Clientis 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 assay qualification, transfer, and troubleshooting as well as product characterization and early reference studies. The core tasks will be focused on designing and executing assay development and qualifications, lead assay transfer projects, and support consistent delivery and implementation of high-quality analytical methods and studies according to milestones across Clienttherapeutic programs. The Scientist will represent the PAD group on the CMC team for early stage development programs and participate in drafting regulatory submissions and associated documentation.
Place in the Organization
The PAD Group is embedded within the Analytical Development department, which also consists of Bio-Analytical Development, and Drug Product Development. The Scientist will be a contributor to the activities of PAD group with a specific attention toward these 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.
Integrating new program products into Clientanalytical platforms, to ensure timely progress of method transfers and regulatory filing efforts.
Representing the PAD group on CMC Teams.
Drafting regulatory filings and regulatory agency responses.
The Scientist reports to the Product Analytical Development Senior Scientist/Team Lead.
Key result areas (major duties, accountabilities and responsibilities)
Design experimental plans underlining qualification, transfer and troubleshooting of assays, and introduction of new analytical technologies.
Contribute to assay development, qualification and transfer activities within a project (including execution, and writing protocols and reports)
Support CMC activities or regulatory filing (e.g. extended characterization, early ref materials, etc.).
Execute experiments and prepare data overviews and reports, including interpretation of results. Suggest next steps in experimental design including rationale for suggestions.
Draft and review laboratory and technical documentation relevant to assay execution (Electronic Laboratory Notebooks, SOPs), qualification, transfer, troubleshooting or other PAD relevant studies (protocols, reports, position papers and memos)
Communicate and align with internal stakeholders on activities relevant to specific projects progression.
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.
Participate in process improvements.
Qualifications & Skills
Minimum of MSc with 4-6 years of industry experience or PhD with 2+ years experience in a Life Sciences-related field (e.g. biochemistry, molecular biology, biotechnology)
Strong interpersonal and communication skills in English, written and verbal including presentation of technically complex data.
Strong experience in assay design, assay development and trouble shooting.
Extensive knowledge and hands-on experience with aseptic cell culture techniques (e.g. insect and human cells)
Extensive knowledge and hands-on experience with relevant molecular biology techniques (e.g. (q)PCR, DNA electrophoresis)
Extensive knowledge and hands-on experience with biochemical analyses (e.g. protein electrophoresis, ELISA)
Experience in viral vaccines or gene therapy is a plus.
Experience in product characterization studies is a plus.
Awareness of GxP pharmaceutical regulations is a plus.
Computer software skills including Microsoft Office.
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
Planning and organizing:ability to plan own work and coordinate with contributing team members to achieve results in a timely way while ensuring the highest standard of quality, and to align planning of multiple complex activities simultaneously.
Detail oriented:strong analytical skills, high level of understanding of assay principles, ability to critically analyze 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 for follow up experiments)
Co-operative:ability and drive to work within an interdisciplinary team, good written and spoken communication skills, ability to communicate and align with internal stakeholders, ability and willingness to work in a fast-paced environment. Self-aware.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.