Job Description:

Aldevron is the industry leader in manufacturing and testing of nucleic acid products supporting gene therapy, and has a challenging and rewarding position for an Associate Scientist/Scientist within the Bioanalytical Method Development and Validation group. This Associate Scientist/Scientist will be responsible for development and optimization of bioanalytical and molecular biological methods that will be used for Good Manufacturing Practices (GMP) release and stability testing of nucleic acid products. The Associate Scientist/Scientist will also be responsible for validation, verification, and transfer of these methods following regulatory guidance.

Responsibilities

• Develop molecular biological and/or bioanalytical methods such PCR, electrophoresis, spectrophotometry, ELISA, and/or HPLC in the laboratory and through collaboration with other groups, including contract testing laboratories Ensure that methods are robust and fit-for-purpose


• Lead activities associated with method validations and transfers including development of validation strategies to meet regulatory requirements including:




• Authoring qualification, validation, and verification protocols


• Analyze results against pre-determined acceptance criteria


• Authoring final reports




• Perform testing and sampling to support validation studies in a GMP environment


• Accurately generate quality laboratory data and validation documents following Good Documentation Practices (GDP)


• Provide training to analysts for newly developed methods that are ready for validation. Also provide additional training as needed related to method implementation into the Aldevron Quality Control release and stability testing laboratory or client site


• Identify and implement new techniques and instrumentation to expand internal capabilities. Prepare justification for new lab equipment

Required Skills

• Experience in assay development, optimization, experimental design, and data analysis, preferably in a GMP environment


• Strong background in development of bioanalytical methods focused on molecular biology, biochemistry, and/or separations including the following: qPCR, electrophoresis, spectrophotometry, chromatography, and/or ELISA


• Good documentation practices and data analysis proficiency are essential


• Experience in bioanalytical method validations and transfers is highly preferred


• GMP and industry experience preferred


• Work on cross-functional teams and apply influencing skills in a matrix environment


• Develop solutions for complex problems, which require a high degree of ingenuity, creativity, and innovation


• Demonstrate high ethical standards, trustworthiness with strong communication and leadership skills

Must-Haves

• Minimum 5 years of experience working in a molecular biology or biochemistry laboratory


• Ph.D. in biology, molecular biology, chemistry, biochemistry, or related scientific field with minimum 2 years of relevant work experience




• M.S. with minimum 4 years of relevant work experience


• B.S. with minimum 5 years of relevant work experience

Join Us Today!

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)

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