Manufacturing Scientist Cover Letter

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

In my previous role, I was responsible for analytical support for clinical-scale non-GMP/ GMP IND-enabling manufacturing operations, including qualification of in-process and release methods, and tech transfer internally and externally, in support of manufacturing and release of clinical material.

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:

• Will require some leadership tasks, including training new operators and partnering with support functions to facilitate execution of production schedules
• Should be well organized, self-motivated and possess excellent time management skills
• Great attention to detail, with good problem solving and analytical thinking skills
• Successful track record showing technical proficiency, decision making, problem solving and troubleshooting
• Experience with process development and validation
• Experience with writing and review of regulatory documents and regulatory requirements such as cGMP, GXP, CLIA
• Experience with cGMP and other quality systems related to medical devices
• Experience in technical problem solving, statistical process control and preparation of submission documentation preferred

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

In the previous role, I was responsible for full analytical testing support in accordance with GMP practices against strict timelines to successfully meet client program milestones.

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

• Business level fluency in English is mandatory, Dutch and French language skills are an asset
• Experience in leading teams and mentoring others
• Project management skills and entrepreneurial drive
• Knowledge of cGMP and ISO requirements as they relate to devices
• Coursework (Design of Experiments, Statistical Process Control, Acceptance Sampling , Engineering)
• Basic knowledge in the handling of chemicals materials and biological samples preferred
• Prior laboratory work involving pipetting preferred
• MS or PhD in Chemical Engineering, Organic Chemistry, or related field

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

Previously, I was responsible for analytical support for clinical-scale non-GMP IND-enabling manufacturing operations, including qualification of in-process and release methods and assist in tech transfer internally and externally in support of GMP manufacturing and release of clinical material.

Please consider my experience and qualifications for this position:

• Experience with common data science toolkits, such as R, Python, Weka, NumPy, MatLab, etc
• Experience with data visualization tools, such as D3.js, GGplot, Tableau, Power BI
• Good scripting and programming skills on Python, R, Scala (Proficiency in one preferred)
• Experience articulating business questions and using mathematical techniques to arrive at an answer using available data
• In-depth knowledge of pharmaceutical/medical device product manufacturing for clinical trials comprising various dosage forms, such as solid oral, ophthalmic, sterile injectable, implant or topical
• Experience with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP)
• Thorough understanding of global regulatory requirements pertaining to clinical trial applications, technical aspects of Chemistry, Manufacturing, and Controls, medical device requirements
• Experience in contract manufacturing of pharmaceutical/medical device product, especially clinical study material

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

In the previous role, I was responsible for experimental and laboratory support in the evaluation and optimization of a diverse set of protein purification techniques through hands-on execution of experimental protocols.

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

• Understand all laboratory procedures
• Provides clear direction on product development requirements to meet exceptions
• Develop products/processes (design, quality improvements, research techniques, ) incorporating multiple tasks within area of expertise
• Independently plan, execute and manage projects/programs that both span multiple disciplines and incorporate novel methods, techniques or approaches
• Apply specialized technical and theoretical knowledge in creative ways to a broad range of difficult problems
• Typically PhD level or with equivalent experience Independently applies scientific knowledge and skills within respective discipline to a variety of assignments
• Leads the innovative efforts and advancing the organziation's intellectual property within own projects
• Supports business development activites

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

In my previous role, I was responsible for analytical support for raw material, in-process and stability samples in fast paced GMP laboratory environment.

Please consider my experience and qualifications for this position:

• Business level fluency in English together with fluency in either French or Dutch is mandatory
• Will perform media and solution preparation, maintain cell lines, small scale roller bottles and shake flask production, large scale bioreactor production, cell harvest, and conduct cellular based assays while utilizing aseptic techniques
• Will perform protein purifications, isotype testing, and analysis by SDS page and HPLC
• Familiar with protein purification methods
• Experience with wave bioreactor operation
• Experience with AKTA purification
• Plan and organize oneself in a consistent manner and maintain work schedules
• Develop skills to perform other duties as assigned