Analytical Associate Cover Letter

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

In my previous role, I was responsible for technical support for analytical method development and validation of laboratory instrumentation and methodologies.

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:

• Familiarity with nucleic acid therapeutic characterization
• Experience in directing the work of experienced scientists and associates and thorough knowledge of cGMP, US and international regulatory requirements
• Experience in supporting CMC teams as an analytical lead
• Thorough knowledge of worldwide CMC regulatory requirements
• Expertise in the development, validation, and transfer of analytical methods
• Able to supervise, coach and develop staff
• Strong leadership/managerial skills and superior oral and written communication skills
• Experience with Hamilton Star/Tecan Evo liquid handling

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

Previously, I was responsible for analytical chemical testing/laboratory work in support of the QAS department, Operations and Quality where required for commercial product support including but not limited to method development, method validation, product testing, degradation profiles, impurity identification, extractable leachable testing, and material contact studies.

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:

• Industry Preference
• Knowledge of enzyme analysis
• Understanding of basic biology
• Hands-on experience with HPLC, UPLC, GC, LC/MS, IC and Dissolution Testing
• Broad knowledge of regulatory and compendial guidance (GMP, GLP, ICH, USP) and practical experience in meeting requirements in a phase-appropriate manner
• Proven track record in leading analytical development activities in various stages of development
• Extensive experience working internally with multidisciplinary teams, and externally with contract research organizations and contract manufacturers
• Proficiency in managing and mentoring analysts, including career development and performance assessment

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

In my previous role, I was responsible for analytical support for cleaning validations, laboratory support requests, equipment validations, method transfers, and API Stability Packaging Description (ASPD).

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

• Experience with ELISA automation
• Experience with the GyroLab Immunoassays
• Experience with Analytical Method Qualification and Validations
• Previous knowledge regarding proteins/antibodies and experience related to analytical methods
• Previous hands-on experience with chromatographic separation techniques like reversed-phase, size-exclusion, and hydrophilic interaction chromatography
• Familiar with advanced mass spectrometry technologies like Q-TOF, Orbitrap, Q-Exactive, Triple Quadrupole MS
• Strong organizational and communication skills and effective interpersonal skills
• Experience in HDX-MS or host cell protein analysis is preferred

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

Previously, I was responsible for oversight and delivery of new and existing analytical services and support to the site ensuring a safe, efficient and functional Laboratory, in accordance with cGLP and cGMP.

Please consider my experience and qualifications for this position:

• Previous pharmaceutical industry experience is preferred
• Basic Knowledge of Classical Wet Chemistry /Chromatographic and spectroscopic techniques
• Stake holder managing skills – Working with people
• Interpretation of spectra from NMR/IR/MS
• Method development using Wet Chemistry /Chromatographic and spectroscopic techniques
• Knowledge of lab auditing systems
• Knowledge of biochemical analysis
• Knowledge of Analytical/instrumental

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

In the previous role, I was responsible for supervision, technical leadership, quality assurance and overall management of the laboratory operations of the Analytical Chemistry Team (ACT) within the Analytical Sciences Division including accountability for team performance and productivity.

Please consider my experience and qualifications for this position:

• Extensive experience with executing a variety of analytical test methods, preparing protocols that comply with statistical randomization principles
• PhD in biological sciences, chemistry or related scientific disciplines with > 10 yrs
• Experience in writing CMC documents for submission to FDA is strongly preferred
• Experience with bio-analytical test methods is desirable
• Experience in supporting regulatory audits is preferred
• BS in a Biology or related field
• Size-exclusion, ion exchange, reverse-phase experience preferred
• Experience in analytical method development/validation and sample analysis