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Pharmaceutical Research Associate
2 months ago
Key Responsibilities:
The selected candidate will become a vital member of the Injectable Drug Product Development team within Integrated Resources, Inc's Pharmaceutical Development and Clinical Supply (PDCS) division. This role involves conducting experimental investigations on various facets of drug product characterization, which includes analytical assessments, biophysical comparability evaluations, and process innovation to facilitate drug product manufacturing. The ability to operate independently while also collaborating effectively within a team is crucial.
Primary Duties Include:
- With limited oversight, design and implement development studies for clinical drug candidates and commercial offerings, focusing on the characterization of protein drug stability and colloidal properties using established methodologies (e.g., circular dichroism, differential scanning fluorimetry, analytical ultracentrifugation, size-exclusion chromatography with multi-angle light scattering detection, etc.).
- Manage multiple assigned tasks and projects efficiently, demonstrating the capacity to work autonomously as well as collaboratively.
- Conduct drug development studies encompassing physico-chemical characterization, UPLC analysis, and stability assessments for drug candidates and commercial products.
- Assist in the preparation of internal technical documentation regarding the studies conducted with minimal supervision.
- Engage in cross-functional development teams to enhance collaborative efforts.
Qualifications Required:
A Bachelor’s or Master’s degree in Biochemistry, Pharmaceutical Science, Chemical Engineering, or a related discipline, accompanied by 2 to 4 years of relevant experience in a pharmaceutical or biotechnology setting.
A solid grasp of protein stability, thermodynamics, and the mechanisms of protein degradation is essential.
Experience with analytical techniques such as imaged capillary electrophoresis (iCE/Maurice), H/UPLC's (IEX, SEC), DLS, CD, DSC, AUC, and NanoTemper is preferred.
The ability to conduct experiments with minimal oversight is a requirement.
Strong interpersonal, collaborative, and communication skills are necessary, along with proficiency in various software applications, including MS Office programs (Word, Excel, Outlook, PowerPoint).
Physical Requirements:
This role is conducted in a laboratory environment. Candidates must be capable of lifting/carrying 15/30 pounds unassisted/assisted and working comfortably in a controlled setting with biological, infectious, and hazardous materials. Responsibilities include gowning/degowning PPE, utilizing a computer, engaging in communications via phone, video, and electronic messaging, and collaborating with others while maintaining general availability during standard business hours.
Preferred Qualifications:
- Experience in characterizing and testing sub-visible particulates.
- Familiarity with biophysical and analytical testing methodologies.
- Knowledge of regulatory guidelines.
- High proficiency in MS Office software, including Word, Excel, Outlook, and PowerPoint.
- Experience with electronic record-keeping software, such as ELN, EndNote, e-logbooks, and maintaining laboratory instrumentation.
- Proactive problem-solving skills and the ability to find solutions to scientific challenges.
- Excellent communication skills and the ability to work effectively in a team-oriented environment.
