Title: Research Scientist

Location- RTP, NC 27709

Expected Start Date:10/28/2024 to End Date 07/25/2025

Duration- 9+ Months (With possibility of extension)

Work Hours: M-F 8:00 am - 5:00 pm

This position is in the Analytical Development group within Bio analytics.

• The selected candidate will be responsible for leading efforts to develop, qualify, validate and implement analytical methods (Biochemical, Immunological, Enzymatics and cell-based Methodology) necessary to support all phases of Drug development projects.
• This position is also responsible for characterizing process intermediates and drug products for current and novel biotherapeutics.
• The ability to analyse, interpret data (including troubleshooting) and relationships in data across different analytical techniques, is essential.
• The incumbent will be expected to work effectively under general supervision and contribute to team efforts to support CMC Development projects.

ESSENTIAL DUTIES and RESPONSIBILITIES include the following.

• Other duties may be assigned.
• Must have strong method development skills
• Must have advanced written and oral communication skills.
• Effectively communicates functional area and departmental technical data in cross-functional settings.
• Must be a subject matter expert in the development, validation and implementation of immunoassay and analytical software for non-linear regression models (e.g. 4 and 5 parameter logistic models).
• Must have considerable knowledge in professional field of specialization, including the awareness and application of applicable regulatory guidance documents.
• Independently applies sound scientific principles in development of innovative solutions to complex technical problems.
• Maintains laboratory facilities in accordance with company policies and industrial best practices.
• Proficient with the use of MS Office software

Requirements:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.
• The position requires PhD plus 2 years' experience, MS plus 3 + years or Bachelors plus 6 years.
• The candidate must have experience using modern instrumental analytical techniques, including plate reader, pH meter, balance, making solutions, single and multi-channel pipetting.
• The candidate should have experience in designing quantitative methods and method qualification/ validation.
• Experience with protein analytical techniques such as enzymatic assays (e.g. coagulation), cell-based assays, gel electrophoresis, and Western blotting is a plus.
• Experience working in a regulated environment and proficiency with statistical software such as SAS JMP is a plus.
• The candidate must be able to recognize when to modify a standard approach to be more effective and incorporates new technology when appropriate.
• Frequent communication with personnel from other departments is often necessary to fulfill project assignments. Excellent verbal and written communication skills are expected.
• The candidate must have a strong work ethic, the ability to exercise good judgment and to work independently with minimum supervision, and be proactive, results oriented, and have strong attention to detail.
• Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
• Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
• Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.

Occupational Demands:

• Work is performed in a clinical and/or a laboratory environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Exposure to chemicals.