Scientist, Analytical Development Cover Letter

I submit this application to express my sincere interest in the scientist, analytical development position.

Previously, I was responsible for expert challenge to drug projects and role model positive behaviours in exploring new ways of working and scientific development.

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

• Experience producing and characterizing antibodies, developing antibody-based assays, improving assays and solving analytical problems
• Industrial or academic experience in a laboratory setting, specifically in bacterial or viral characterization
• Demonstrable subject matter expertise in assay development and validation
• Working knowledge of the vaccines regulatory environment in US and/or EU
• Provide analytical oversight of external vendors for preclinical and Phase I - III CMC activities for small molecule drug substance (DS) and drug product (DP) with limited supervision
• Provide oversight and direction in phase appropriate development, validation and transfer of analytical methods for raw materials, in-process control, DS and DP testing for CMOs
• Participate in the development and revision of product specifications, provide scientific input and critique of analytical results
• Review the quality control testing of clinical trial supplies manufactured at CMOs

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

Previously, I was responsible for analytical development expertise to influence decisions on scientific/technical issues related to assigned internal and/or outsourced projects.

Please consider my experience and qualifications for this position:

• Understanding and practical knowledge of GMPs as applied to analytical requirements
• Strong awareness of industry/regulatory trends
• Expert in RNA biochemistry
• Experience in performing biophysical characterization of RNA
• Experience in performing RNA kinetic studies
• Experience of running cell based and biochemical assays to deliver decision making data for process development projects
• An interest in and willingness to develop skills in downstream process development of viral vector bioprocessing and scale up (up to 200L)
• Experience in running cell based assays to deliver critical data for project teams, with FACS and qPCR readouts, ideally that would include titration of viral samples to determine functional titres

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

In my previous role, I was responsible for sample testing support for process development, formulation development, critical reagent characterization and for on-going stability studies.

Please consider my experience and qualifications for this position:

• Participate in the preparation of CMC and IMPD sections of regulatory submissions along with other functional groups
• Ensure compliance with analytical requirements for CMC regulatory submissions
• Familiarity with a broad range of analytical techniques for characterization of pharmaceuticals including thermal methods, HPLC & GC with a variety of detection methods, wet chemical analysis (KF, dissolution, ), spectroscopic techniques, particle size, and heavy metal analysis
• Strong analytical, communication, presentation, and writing skills
• Experienced in protein purification via affinity, hydrophobic interaction (HIC), ion exchange (IEX), size exclusion (SEC) and mixed-mode chromatography
• Solid working knowledge of DOE
• Experience in the biopharmaceutical industry is preferred
• Experience with monoclonal antibodies is preferred

Please consider me for the scientist, analytical development opportunity. I am including my resume that lists my qualifications and experience.

In the previous role, I was responsible for scientific and technical guidance to analytical development programs in support of the development, qualification, GMP implementation, and scale-up of cell analytics methods.

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:

• Lateral thinking and creative
• Knowledge of the regulatory requirements (FDA, EMA) that apply to the development of physical/chemical methods for GMP control and release of biopharmaceuticals
• Ph.D in a scientific discipline such as Immunology, Virology, Biochemistry, Microbiology or Bioengineering or related discipline
• Hands on experience with ELISA, qPCR based assays, and cell based bioassays
• Knowledge of the principles and practices of basic computer applications used in general office settings, including word processing, spreadsheet, database management, presentation software, and internet search engines
• Positive attitude and motivation to work with the team to meet corporate and personal goals
• Knowledge of the regulatory environment, particularly guidelines on analytical method development and validation and application of compendial methods and standards
• Broad experience with cell-based assays

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

In my previous role, I was responsible for scientific and technical guidance to analytical development programs in support of the development, characterization, qualification, GMP implementation and scale-up of cell analytics methods.

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:

• Experience in the development of physico-chemical analytical methods (electrophoresis, western blotting, HPLC, particle size analysis, LC-MS, biosensors) to characterise viruses and cells
• Good understanding of statistics and application to method development
• Previous experience with sample handling and/or analytical testing
• Previous experience developing analytical methods in an industry or academic setting
• Experience with critical reagent generation and screening
• PhD or equivalent scientific education in the scientific field with an appropriate amount of industry experience within biopharmaceuticals development
• Scientific excellence, regulatory knowledge and technical expertise in relevant scientific field
• Project management skills to work as Project Team Member