Process Development Scientist Cover Letter

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

In my previous role, I was responsible for routine GMP cell processing and facility/equipment support with research and development work on an as needed basis.

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 mentoring junior staff regarding laboratory procedures and scientific projects
• Knowledge of and hands-on experience with mammalian cell culture, bioreactors, bioreactor process development, and bioreactor data analysis is preferred
• Knowledge and hands-on experience with downstream processing and purification of antibodies, in particular chromatography and filtration is preferred
• Knowledge of analytical methods to characterize processes including cell based assays, flow cytometry, and proteomic/genomic methods
• A good understanding of protein biochemistry as it relates to protein purification process development
• Prior GLP/GMP experience
• Hands on experience with purifying proteins using equipment such as chromatography purification systems (e.g., AKTA Avant), TFF and NFF systems (e.g., AKTA crossflow, Pendotech TFF), and high throughout purification system (e.g., TECAN)
• Have a basic understanding of scale up and scale down principles for chromatography and filtration unit operations and column packing procedures

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

In my previous role, I was responsible for organic chemistry expertise and support cross-functional research activities as needed.

Please consider my experience and qualifications for this position:

• Physicochemical-based unit operations
• Experience of running biochemical assays to deliver critical data for project teams, especially ELISA assays and ideally the determination of physical titre and infectivity for viral vector samples
• Experience of analytical methods for biological molecules to determine concentration and critical quality attributes
• Experience of assay automation for cell based and biochemical assays
• Performing hands-on laboratory experiments involving filtration and chromatography
• Downstream process development, optimization, characterization, and tech transfer
• Support process scale-up activities in the pilot plant and clinical and commercial manufacturing sites
• Prepare/review technical documents including development / tech transfer reports, batch records, and SOPs

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

Previously, I was responsible for technical leadership and testing support to multiple lab areas, including elemental, organic chemistry, thermal, and physical measurements.

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

• Provide solutions to a variety of problems of diverse scope involving basic scientific principles
• Previous experience with purification and/or characterisation of nucleic acids desirable, but not essential
• Operating and maintenance of AKTA systems and knowledge of Unicorn software
• Experience of analytical methods for protein characterization with Waters or Agilent chromatographic systems
• Multifactorial Statistical Design software
• At least six months experience with aseptic and cell culture techniques
• Experience with cell-based (imaging, flow cytometry) and biochemical analytical techniques
• Experience in programming/coding

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

In the previous role, I was responsible for technical opinions and recommendations to the members of the Process Development Department in order to elaborate chemical manufacturing processes that are safe, economical, and in compliance with cGMP requirements.

Please consider my experience and qualifications for this position:

• Experience in Biotech or Pharmaceutical industry, preferably in a fully or partially automated lab environment
• Analytical chemistry/biochemistry experience with the emphasis on experience and in-depth working knowledge of LC, Caliper, CE, iCE and immunoassays
• Experience operating and maintaining laboratory automation/robotic systems
• Experience in cell culture and/or purification of proteins, viruses, VLPs, and/or other biological molecules
• Preferred knowledge and hands on experience with bifidobacteria and lactic acid bacteria physiology, genetics, and food fermentation systems, including cheese
• Preferred background utilizing genomics, transcriptomics, proteomics, and metabolomics methodologies for knowledge and discovery based improvement of lactic acid bacteria and bifidobacteria performance
• Development work experience using microencapsulation technologies
• Freeze drying (lyophilization) cycle development experience for drying and enhancing cell performance

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

In the previous role, I was responsible for support to the Managers and other team members, under a multi-shift manufacturing environment utilizing their organic synthesis experience.

Please consider my qualifications and experience:

• Experience in aseptic handling of Chinese hamster ovary cell cultures
• Demonstrated skills in cell culture media formulation preparation
• Experience with the operations of fed-batch and perfusion processes
• PhD in Molecular Biology or Biochemistry, with additional knowledge in Analytical Chemistry and/or Chemical Engineering
• Hands-on experience in upstream process development, including activities such as medium and process optimization, scale-down model development, process characterization, scale-up, and technology transfer
• Experience in applying QbD principles and Risk Assessment strategy to guide process development
• Experience authoring CMC sections of IND/BLA/MAA and other regulatory documents
• Upstream process development and manufacturing sciences experience