The Scientist I, Analytical Method Validation (AMV) in Technical Operations is responsible for validating bioanalytical methods that are transferred either from clients or from the Analytical Method Development (AMD) group. This role will mostly focus on performing experiments to generate data to support validation of these methods. Duties include, but are not limited to, performing experiments, interpreting results, communicating results, and drafting documentation. The Scientist I must interact closely with the AMD team to ensure that methods are transferred correctly.
With guidance from the Senior Scientist, the Scientist I designs and executes validation protocols. The Scientist I relies on education and experience to troubleshoot experiments, with technical oversight provided by the Senior Scientist, when necessary. The Scientist I will also be qualified to train others on the methods they have validated.
* Work closely with scientific staff to execute laboratory experiments in support of validation of biochemical assays
* Analyze and summarize experimental findings
* Identify problems, reports issues to staff scientists, and assist in troubleshooting
* Prepare reagents and buffers
* Prepare presentations to report scientific findings
* Successful execution of method validation protocols
* Generation of validation final summary reports as assigned
* Review completed validation documentation to ensure actual results match expected results and all deviations that occur during the validation process are resolved appropriately
* Provide input for Standard Operating Procedures (SOPs) and validation documentation consistent with FDA and European Union regulations and customer requirements.
* Perform other duties as assigned
* All employees are responsible for the general upkeep of work and shared spaces
* Punctual and regular attendance is required of all employees
* Knowledge of GMP regulations in cGMP manufacturing and testing environment
* Knowledge of documentation protocol
* Good communication, planning, and organizational skills
* Good working knowledge of Microsoft Office
* B.S. in Microbiology, Biochemistry, Biotechnology, or related field with 1-3 years of laboratory experience; preferably in a cGMP and/or Quality Control environment
* Experience with plate readers, ELISA, electrophoresis equipment, HPLC, capillary gel electrophoresis, RT-PCR, digital droplet PCR, and aseptic techniques
* Experience working with nucleic acids and/or proteins
* Expert experience with pipetting techniques
Monday-Friday – 8 am – 5 pm
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Join a team committed to making lives better. Aldevron provides high-quality plasmid DNA, proteins, enzymes, antibodies, and other biologics to help our partners achieve significant breakthroughs for a variety of life science applications.
If you would like to thank someone for referring you to this role, please apply at www.aldevron.com/careers, and include their first and last name as a referral source!
Aldevron is committed to equal opportunity for all employees and applicants. We are committed to creating a diverse workforce and consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identify, or protected veteran status among other factors.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)