Senior Principal Scientist Job Description
Senior principal scientist
provides technical leadership to matrixed project teams within area of expertise and commits resources to execute specific project tasks.
Senior Principal Scientist Duties & Responsibilities
To write an effective senior principal scientist job description, begin by listing detailed duties, responsibilities and expectations. We have included senior principal scientist job description templates that you can modify and use.
Sample responsibilities for this position include:
Manage and oversee stability and analytical studies for projects
Develop and maintain appropriate cellular and molecular in vitro/ in vivo/ex vivo assays
Communicate results to multi-disciplinary teams
Capable of designing, conducting, interpreting, and reporting in vitro and in vivo data
Experience and expertise in the interpretation, analysis, documentation, and presentation of results to scientists and management at all levels
Comfortable and confident representing DMPK on multidisciplinary project teams
Contribute to technical reports and present results at periodic project review meetings
Comply with applicable regulations (GLP and GCP)
Author and oversee writing of study reports, patents, and peer-reviewed publications
Development and validation of analytical methods used in the leachable testing of drug products by means of various procedures including HPLC/UV, HPLC/MS GC, GC/MS, and ICP-OES
Senior Principal Scientist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Principal Scientist
List any licenses or certifications required by the position: DABT, MS, ECVP, ACVP
Education for Senior Principal Scientist
Typically a job would require a certain level of education.
Employers hiring for the senior principal scientist job most commonly would prefer for their future employee to have a relevant degree such as Master's and Bachelor's Degree in Chemistry, Science, Biology, Biochemistry, Engineering, Computer Science, Education, Statistics, Technical, Pharmaceutical Sciences
Skills for Senior Principal Scientist
Desired skills for senior principal scientist include:
Field of expertise
Field of toxicology
Specific platforms
Biopharmaceutical classification system
CGMP
Visibility outside of functional area
Certain aspects of process operations
IVIVC / IVIVR
Project teams to ensure delivery of project timelines according to customer needs
Advanced mass spectrometry
Desired experience for senior principal scientist includes:
Sound knowledge of drug disposition, drug metabolizing enzymes, transporters, management of laboratory and Ph.D.-level staff, and substantial experience representing DMPK on project teams
Understanding of chemical mechanisms, formation of reactive metabolites
A broad understanding of the role of DMPK in drug development would be an advantage, as the position will provide opportunities to appraise in-licensing candidates
Understanding of bioanalytical approaches for advanced therapeutic modalities a plus
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
Demonstrates a broad knowledge of field (electrophysiology, pharmacology, physiology, pharmacokinetics, pharmacodynamics or pharmaceutics)
Senior Principal Scientist Examples
1
Senior Principal Scientist Job Description
Job Description Example
Our company is looking for a senior principal scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior principal scientist
- Perform and/or assign other duties as requested to ensure smooth operation of department
- Ensure timely completion and delivery of analytical results and documentation (technical reports, SOPs, ) to support product development during clinical phases
- Independently design, conduct and analyze data for in vivo TK, PK and PK/PD studies in multiple veterinary species for large molecule and/or small molecule therapeutics
- Provide PK and PK/PD modeling and simulation to help select lead candidates and optimize dose regimens
- Serve as study director or principal investigator for in vivo PK, PK/PD or TK studies (GLP and non-GLP), including writing protocols and reports
- Work collaboratively with interdisciplinary teams to prosecute studies and projects in line with the strategic direction of the team
- Present results to scientific teams, management, and regulatory agencies
- Write sections of regulatory submissions, respond to inquiries from regulatory agencies, and maintain knowledge of regulatory guidance documents
- Mentor other scientists
- Represent Analytical Sciences on project teams and lead analytical subteams, collaborating closely with scientists from Process and Formulation Development, Biologicals Research, Clinical, Regulatory, Project Management, and Manufacturing/Quality Control to deliver robust methods and products
Qualifications for senior principal scientist
- PhD in Pharmacology, Biochemistry, or related discipline with a minimum of 4 years of industry experience in PK/PD of small or large molecules, or a BS/MS with a minimum of 8 years of relevant industry experience
- Demonstrated ability to design, analyze and interpret in vivo PK and PK/PD studies
- Skilled in the used of PK and PK/PD modeling and simulation software such as WinNonlin, NONMEM
- Highly independent with the ability to innovate within the discipline
- Working knowledge of analytical methodology for large molecule and small molecule analyses, including ligand binding assays (immunoassays) and LC/MS/MS assays
- Experience conducting GLP regulated studies
2
Senior Principal Scientist Job Description
Job Description Example
Our innovative and growing company is looking for a senior principal scientist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior principal scientist
- Lead diagnostic projects from concept to approval or launch, including the project planning to maintain timelines
- Lead through example by working hands-on at the bench to design and develop workflows for stable transfection of Chinese Hamster Ovary (CHO) cells for expression of monoclonal antibodies and recombinant proteins
- Establish protocols for CLD workflows that ensure clonality and stability of transfected cell lines
- Identify strategies that support the mid-term goals of the CLD function and some projects will be self-initiated
- Independently research and proposes PCR and PCR sample preparation technologies applicable to our PCR platforms
- Develop and validate PCR based diagnostic tests against a diversity of pathogens, including viruses, bacteria and parasites in collaborations with the instrument development team
- Functional lead and inspire a group of MRI research scientists in the organization
- Collaborate with global research team to carry out industrial research to fulfil local and global business needs
- Build up and enhance academic and clinical collaboration through open innovation
- Lead and oversee cross-functional teams to drive NTC-based candidate selection/nomination to contribute to BI’s pipeline in immunological diseases
Qualifications for senior principal scientist
- Experienced with monitoring work at CROs
- Experience developing population PK models and/or evaluating PK variance in clinical populations
- Experience with radiolabeled (14C and/or 3H) drug disposition studies
- A track record of success in a matrix research organization, know how to leverage all the resources available, even those outside your line, to accomplish your goals
- Previous experience in the Animal Health pharmaceutical/vaccine industry or of parasitology
- Has a good tool set (e.g., Access, Excel, R, SAS, Python, RDBMS, ClickView, Tableau)
3
Senior Principal Scientist Job Description
Job Description Example
Our company is growing rapidly and is looking for a senior principal scientist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for senior principal scientist
- Continue to develop scientific expertise, credentials and drug development expertise by keeping abreast of relevant literature, by expanding scientific/technical knowledge and by publishing in peer-reviewed journals and speaking at internationally-recognized scientific conferences
- Provide immunology and immunogenicity expertise to biologic drug development programs from early stage research to post-marketing
- Develop risk-based immunogenicity assessment strategies for novel biologic therapeutics with a focus on clinical impact
- Analyze and interpret immunogenicity data from nonclinical and clinical studies to determine clinical relevance and translatability
- Lead analysis efforts across clinical trials and biologic programs to better understand emerging immunogenicity trends across modalities and indications
- Represent the Immunogenicity Assessment function on multiple cross-functional development teams and contribute to strategic and scientific planning and execution
- Author Immunogenicity sections of regulatory submissions, such as clinical study reports, investigator brochures, integrated immunogenicity reports, and BLA/MAA dossiers
- Manage interactions with key opinion leaders and regulatory agencies on immunogenicity-related issues
- Present results and key messages of immunogenicity findings to internal teams, executive management, external collaborators, and regulatory authorities
- Author immunogenicity-focused publications and present findings at conferences and other public forums
Qualifications for senior principal scientist
- Strong technical and scientific background paired with several years of practical industry experience in development, characterisation, scale-up and launch of biomolecules, preferably vaccines
- Strong background in DoE/Process excellence and investigation tools
- MSc in molecular biology / biotechnology or related discipline with a minimum of 10 years of demonstrated work experience, including 5 years of PCR assay development experience
- PhD in molecular biology / biotechnology or related discipline with a minimum of 3 years of demonstrated work experience, including 2 years of PCR assay development experience
- Experience with Lab-on-chip / microfluidics technology
- 6-10 years of pathology experience post-DVM
4
Senior Principal Scientist Job Description
Job Description Example
Our growing company is hiring for a senior principal scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior principal scientist
- Collaborate extensively with other members of the Immune Modulation Group in Ridgefield and globally, the larger BI’s Global Immune Modulation Biotherapeutics Discovery (IMBD) Division
- Maintain close customer contact during projects
- You are accountable for all project biomarker deliverables
- We ask you to provide a biomarker plan (including time lines/ time frame, data analysis plan) and to identify and prioritize biomarker platforms
- Optimally address the research and development objectives on the assigned projects
- Developability assessment of Discovery portfolio leads
- Definition of the drug product trajectory
- Solid state form selection for the drug substance
- Characterization of Drug Substance, Raw materials and Drug Product
- Accountable for analytical method transfer from Medimmune’s Biopharmaceutical Development to commercial manufacturing sites within AZ Biologics operations outside testing laboratories
Qualifications for senior principal scientist
- Completed MSc and/or PhD in Electrical Engineering, Physics, Biomedical Engineering or other related field
- The candidate shall with have >8 years for MSc and/or >6 years for PhD on relevant working experience
- MR image reconstruction and/or MR imaging processing and analysis
- Development experience with MRI pulse sequences is a plus
- Highly motivated and passionate on MRI research
- Chinese is a plus
5
Senior Principal Scientist Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of senior principal scientist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for senior principal scientist
- Design and manage preclinical studies (GLP and non-GLP) for inclusion in regulatory submissions, including pharmacology, toxicology, and biodistribution/shedding studies
- Monitor conduct of preclinical study with CROs
- Develop, and write, position papers on safety, pharmacology and mode of action to support product development
- Prepare and edit non-clinical documents for regulatory submission
- Maintains a current understanding of pharmacology and toxicology literature and methodology, the scientific literature related to the specific drug discovery projects
- The Scientist will report directly to the Head ofPreclinical Development
- Lead in proposing and implementing new experimental designs and concepts that contribute to core group/research goals and reflect expert knowledge
- Independently communicates results by preparing clear technical reports, publications and oral presentations
- Functions as an acknowledged resource and technical leader within and outside of the department in a specific project-relevant area OR technology
- Independently designs and performs scientific experiments with a predefined goal including developing new methodologies, protocols and or test procedures that contribute to core group/research goals and reflect expert knowledge
Qualifications for senior principal scientist
- PhD from an accredited institution in Immunology or related field with minimum seven (7) years of post-doctorate experience, prior experience in biopharmaceutical industry R&D is highly preferred
- Strong understanding of immunological principles and disease mechanisms with excellent grasp of in vitro and in vivo experimental model systems for evaluating immune modulatory activities, in particular of myeloid cell types
- A solid understanding of multiple aspects of the drug development process, including target identification/validation, candidate selection, disease positioning and biomarker discovery
- A demonstrated track record of independent research and peer-reviewed publications in areas of immunology research, with prior experience in studying human immune system highly desired
- Excellent oral and written communication skills, with the ability to propose, articulate, evaluate and defend scientific ideas and data
- Experienced in both managing director reports and influencing without authority