Analytical Development Cover Letter

I would like to submit my application for the analytical development opening. Please accept this letter and the attached resume.

In the previous role, I was responsible for analytical method Development expertise for global and local (India) projects in the area of pharmaceutical formulations and drug delivery systems.

Please consider my experience and qualifications for this position:

• Acknowledged SME in at least one core aspect of process development for vaccines
• Good understanding of the vaccines regulatory environment
• Good understanding of the USDA and GMP vaccines manufacturing requirements
• A significant academic or industry profile
• Excellent understanding of the vaccines regulatory environment
• Excellent understanding of the USDA and GMP vaccines manufacturing requirements
• Experience leading a team – potentially team lead rather than manager
• Analytical Method Development Experience (Developing is key)

I am excited to be applying for the position of analytical development. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for leadership and participates in performing method qualifications and transfer robust and compliant test methods via documented procedures and training of Quality Control, Process Development, and Manufacturing personnel in the execution of the newly developed assays.

Please consider my qualifications and experience:

• Practical knowledge JMP and Empower software
• Familiarity with methods for physicochemical characterization (XRPD, DSC, TGA)
• Proficient using MS-Office, experienced with common data systems for computer controlled instrumentation
• Significant theoretical and practical experience in several key technologies routinely applied to pharmaceutical and chemical analysis
• Good cross-functional understanding related to drug substance and drug product development
• Exhibit leadership/organizational skills in facilitating cross-functional scientific discussions, seeking input/support from subject matter experts to address/resolve issues and follow through with actions
• Experienced with writing/reviewing scientific documents, such as specifications, COAs, CQA risk assessments, protocols and reports
• Knowledge of FDA, EMEA and ICH guidelines

I would like to submit my application for the analytical development opening. Please accept this letter and the attached resume.

Previously, I was responsible for analytical testing to support process development teams as well as conduct Current Good Manufacture Practices analytical activities (analytical method development, validation and product stability testing).

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:

• Hands-on experience in analytical development in support of recombinant viral vector production, gene therapy or cell therapy
• Adhering to quality, regulatory and safety standards in the laboratory
• Hands-on experience in the performance of flow cytometry methods to characterize cells
• Familiarity with data analysis/statistical software packages
• Performance of cell culture based functional assays
• Experience with development, qualification and validation of biochemical protein characterization methods is preferred
• Experience with LIMS, ELN, CDS systems is highly desirable
• Organized and efficient worker

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

In my previous role, I was responsible for analytical expertise and support for the introduction of new products to the Cork site, including method assessment, method development, validation/qualification and transfer.

Please consider my experience and qualifications for this position:

• BSc level in biotechnology, biochemistry or life sciences
• In depth knowledge of, and experience in a broad range of analytical techniques
• Develop and execute protocols for test method and equipment qualification
• Ensures timely methods transfers to CRO’s, including protocols and reports
• PhD/MS in Analytical Chemistry, Chemistry, Pharmaceutics or related science or BS with equivalent experience
• Experience with basic protein characterization techniques such as UV-VIS, IEF/icIEF, SEC, and RP-HPLC
• Deep practical experience in separation techniques and detection methods, including reverse phase, normal phase, ion exchange, and size-exclusion chromatography
• Strong oral and written communication skills, with experience in preparing protocols, technical reports, and regulatory filings

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

Previously, I was responsible for scientific/technical consultation to other scientists and business units internally, including method and testing support to global plant and R&D analytical labs; Product Development; Quality Assurance; and Regulatory Affairs.

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:

• Demonstrated successes in a team environment, such as project teams, problem solving teams
• Stakeholder management of multiple decision makers, corporate colleagues, cross functional teams
• Project management qualification such as, Project Management Professional (PMP) Evidence of Continuous Professional Development
• Strong familiarity with regulatory agencies (ISO, UPS, ASTM, AAMI)
• Project coordination skills to head and steer technical projects
• Creativity, innovative mindset and leadership in evaluating and implementing new technologies or process improvements
• Demonstrated technical leadership and technical abilities, including working knowledge of modern analytical chemistry techniques, laboratory equipment and methods
• Will be exposed to some incidental chemical fume exposure, typical of a chemsitry laboratory environment