Associate Principal Scientist Cover Letter

I would like to submit my application for the associate principal scientist opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for statistical support to study protocol for design and analysis of Real World Data, sample size calculation to determine power, and statistical analysis.

My experience is an excellent fit for the list of requirements in this job:

• Good working knowledge on key metabolic enzymes and related biochemical pathways
• Strong foundation in chemistry, materials science, and analytical sciences, with specific experience in separation technologies
• Knowledge of compendial methods, cGMPs and applicable guidance documents from various regulatory bodies
• Extensive experience with eCTD and other regulatory documentation focused on quality and drug substance
• Problem solving abilities and drive to create alignment between R&D, toxicology, quality, regulatory and other stakeholders in development
• An understanding of human genetics and the tools used to identify disease-associated genetic variation
• Strong in vitro and cell biology techniques including primary and recombinant cell culture, molecular cloning and gene expression in human cellular systems, Western blotting, immunocytochemistry
• Lead as a technical expert and scientific contributor

In response to your job posting for associate principal scientist, I am including this letter and my resume for your review.

In my previous role, I was responsible for statistical expertise, study design, and analysis and communicate data driven decisions for biologics process improvements, process understanding, method development, transfer and validation, and stability studies in collaboration with personnel.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Technical expert on post approval support and post commercial process enhancements
• Deep technical knowledge and in-depth experience with upstream process development including expertise in harvest and primary recovery unit operations (centrifugation, depth filtration) and raw materials
• Experience supporting/writing regulatory filings (IND, BLA), responding to regulatory questions and inspections with multiple agencies (FDA, EMA, JNDA)
• Demonstrated experience in a broad range of activities for atomic resolution single particle cryo-EM, including sample preparation, data collection, image processing & 3-D reconstruction
• Demonstrated potential to develop project management skills and identify/develop new areas of scientific expertise in cryo-EM
• In-depth technical knowledge and expertise in the characterization of biological molecules.　
• Experience with HPLC and/or UPLC method development and qualification
• Experience with people management and/or team leadership in late-stage development or commercialization teams.　

In response to your job posting for associate principal scientist, I am including this letter and my resume for your review.

In the previous role, I was responsible for technical leadership in tasks that include design of experiments (DOE), analysis of data, statistical process control (SPC), simulation, design of sampling plans, and problem solving.

Please consider my qualifications and experience:

• Technical expertise in purification of biological molecules from mammalian-based expression systems, including laboratory skills in chromatography and filtration systems.　
• Experience in of the following disease areas
• PhD in biosciences with postdoctoral training and research experience in the fields of human cancer immunology or human immunology
• Previous drug discovery experience in the areas of immunology or cancer immunology is an advantage
• Excellent team working, organizational and presentation skills (English as a working language, basic German an advantage)
• Extensive experience in noncompartmental analysis and pharmacometric modeling and simulation including use of WINNONLIN and NONMEM or similar statistical modeling software
• Knowledge of R, SAS, MATLAB or similar modeling software and substantial experience building NONMEM datasets
• Experience in oncology and immuno-oncology model development and application is essential, experience in translational aspects of hematology/oncology drug development is preferred

I submit this application to express my sincere interest in the associate principal scientist position.

Previously, I was responsible for statistical expertise and leadership for marketing and physician requests; including statistical methods, table and graph shells and statistical programming specifications, analyses and data presentation, and interpretation of results for abstracts, presentations, and manuscripts.

Please consider my experience and qualifications for this position:

• Can manage multiple projects under tight timelines
• Experience managing data transfer processes and timelines
• A solid understanding of foundations of regulated bioanalysis, drug metabolism, drug interactions, PBPK modeling, biomarkers and biostatistics
• Experience writing clinical pharmacology/pharmacokinetic/pharmacometric reports and regulatory submissions and performing quality control
• Solid knowledge of regulatory requirements governing drug development
• Resourcefulness, pragmatism, creativity and an independent work ethic
• Experience in recombinant protein expression, purification and analytics for target proteins and antibodies
• Multiple Publications and external presentations demonstrating creative application of computational approaches to problems of biological or chemical interest

I submit this application to express my sincere interest in the associate principal scientist position.

In my previous role, I was responsible for statistical support for clinical studies, including study design, sample size calculations, patient randomization, statistical analyses, interpretation of data, and reporting of results.

Please consider my experience and qualifications for this position:

• Providing technical and/or programming guidance and mentoring to colleagues
• Knowledge, understanding, and experience performing immunochemical and/or cell based assays
• Track-record of independent problem-solving and application of advanced innovative scientific approaches
• Committed to working in a collaborative manner across functional areas
• Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics , computational biology/chemistry, chemical/biomedical engineering, or a related field
• Proficiency in R, Matlab, SAS, or other similar programing language
• This includes experience with data analysis platforms such as MatLab, OmicSoft, or R
• Demonstrable and successful project management and team management experience