"Alerted.org

Duration: 12 months contract, Full-Time

Job Description:

+ This is an onsite, lab-based contractor role located in Malvern, PA. The Analytical Method Development Scientist will execute routine cell culture and develop cell-based assays for acidity and impurity analysis, including ELISA.

+ Responsibilities include developing and coordinating analytical methods for clinical and commercial therapeutic products, collaborating with cross-functional lab teams, and working on multiple experiments as indicated by internal needs. The Scientist will analyze data, maintain documentation, and contribute to method development activities prior to manufacturing.

Responsibilities:

+ Executing routine cell culture and cell-based acid development assays

+ Developing, validating, and analyzing ELISA and impurity assays (including HCP)

+ Collaborating with client scientific analysts and lab managers to coordinate lab support

+ Working within a cGMP environment to ensure compliance

+ Maintaining thorough documentation and analyzing experimental data before initiating new experiments

+ Supporting developing methods for clinical and commercial therapeutic products

+ Participating in a dynamic, cross-functional team to address job board requests and lab priorities

Experience:

+ Direct experience in analytical method development, preferably prior to manufacturing

+ Minimum 2 years of relevant industry experience.

+ Experience working within a cGMP environment

+ Strong technical writing and verbal communication skills

+ Excellent interpersonal skills and ability to collaborate across teams

+ Proficient in using Electronic Notebooks for documentation

Skills:

+ Proficient in at least two of the following: cell-based potency assay, ELISA, FRET, qPCR, cell culture and aseptic technique, flow cytometry, plate-based biochemical assays (e.g., impurity, HCP)

Education:

+ Master’s degree in a relevant field with a minimum of 1 year of industry experience.

+ Bachelor’s degree in biology, Biochemistry, or a related field.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com (http://www.ustechsolutionsinc.com/) .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,

national origin, disability, or status as a protected veteran.