Scientist - Pharmacokinetics

Job Description Summary

In the Senior Scientist role, the candidate will apply practical expertise to the design, development, qualification, and implementation of bioanalytical assays for pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity (IG) studies across all phases of the drug discovery & development pipeline in a non-regulated and GCP environment.

Job Description

Job specific responsibilities will include but are not limited to:

• Design, develop, qualify, and implement bioanalytical assays for PK, TK, PD, and IG assessment supporting various modalities such as biologics, cell and gene therapy, and oligonucleotides platforms using adequate techniques following SOPs and guidelines for GCP analysis.
• Deliver high quality data within defined timelines and aligned to current industry expectations.
• Complete study sample analysis and draft the bioanalytical report in support of project requests.
• Support in representing the bioanalytical function on project teams and present results, data interpretation, timelines, etc. at project team meetings.
• Collaborate with internal and external stakeholders to evaluate new bioanalytical technologies and solutions to support challenging project requests.
• Be responsible for all assigned study/lab/project activities and provide input to bioanalytical strategies.
• Independently or with the help of a team lead, design and develop, validate assays, and perform sample analysis.
• Process data, evaluate results, interpret data, and draw relevant conclusions. Critically analyze data on study and project levels.
• Conduct lab activities and keep timely raw data records in accordance with company and health authority guidelines.
• Maintain a high level of competence on routinely used laboratory equipment and/or LIMS systems. Evaluate and set up new technologies as they are introduced to the lab.
• Lead the general lab environment, including instrument maintenance, writing/updating templates and SOPs, software validation activities, ordering supplies, etc.
• Coach and mentor in a matrix team environment.

Experience:

• College/university degree in biological related sciences or equivalent, with 3+ (Masters) or 5+ (Bachelors) years of experience. Experience in biologics bioanalysis preferred.
• Strong laboratory skills with expertise in cell activation assays using reporter systems, ligand binding assays (e.g. ELISA, MSD or other), drug potency assays.
• Proficiency in protein purification, immunoprecipitation, and antibody pull-down assays will be an advantage.
• Ability to work with minimal supervision and organize work across multiple projects to meet timelines.
• Eagerness to take on additional responsibilities when required; flexibility to adapt to changing priorities and strategies.
• A collaborative spirit and willingness to mentor/coach peers.

Additional accountabilities:

• Skilled in collaboration across project team labs.
• May suggest/build new network connections within existing project teams.
• Routinely train members of lab and broader project team in familiar techniques.
• Expected (if needed) to undertake organizational responsibility (such as equipment power user, lab safety rep).
• Accountable for increasingly complex experiments; key contributor to the success of drug discovery, technology, and/or early development projects.
• Bring ideas from a concept or question to a decision in experimental design, based on previous observations.
• Report technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt - Distribution of marketing samples (where applicable).

Key performance indicators:

• Discoveries
• Developments
• Experimental methods
• Adherence to Novartis policy and guidelines
• Project & stakeholder feedback

Additional skills:

• Collaborating across boundaries.
• Project Management.
• Collaboration.
• Curiosity.
• Drug Development.
• Flexibility.
• Pipeline (Software).
• Teamwork.

Languages:

• English.

Skills Desired:

• Adobe Photoshop
• Chemistry
• Collaboration
• Compensations Management (Employees)
• Curiosity
• Drug Development
• Employee Recruitment
• Flexibility
• Oscilloscope
• Patient Care
• Pipeline (Software)
• Sales
• Small Business
• Teamwork