Sr Associate Research Scientist II

2 weeks ago

Clayton, United States TalentBurst, Inc. Full time

Industry: Medical Practice
Position: Sr Associate Research Scientist II
Location: Clayton, NC - 27520
Duration: 12 Months Contract with chances of extension 

Overview:
  • The incumbent will provide technical and scientific expertise in the research and development of plasma derived or recombinant proteins or in support of the manufacture of plasma derived or recombinant proteins. The incumbent is a technically competent professional who uses their expertise to assist in executing a compliant stability program to support licensed products and developmental projects, ensuring the on-going quality and safety of marketed material, in addition to implementing solutions to a variety of company related objectives. .
  • Incumbent will be responsible for providing stability support for company's products (marketed and/or development), generation of stability protocols and reports, reviewing and analyzing incoming data, and authoring Stability documents in support of Regulatory submissions. He/she may participate in interdepartmental product project teams and present stability data to peer and management groups.
  • In addition, he/she will work in partnership with Manufacturing/Technical Operations/Supply Chain/Research and Development to conduct and resolve investigations of unexpected stability data and trends.T
  • Additional responsibilities may be assigned by department manager. Responsibilities for Sr Associate Stability Research Scientist II · With supervision, develops action plans in support of departmental goals. · Executes action plans independently or as part of a team. ·
  • Capable of reporting project activities to immediate supervisor and within group meetings. · Independently prepares procedures or technical reports, including data interpretation. · With minimal supervision, prepares and effectively communicates technical results in cross-functional team settings. 
  • Independently applies sound scientific principles in development of solutions to complex technical problems within area of expertise. · Applies professional principles, established techniques, and company's policies and procedures in completion of job tasks. · Assists in the design of scientifically complex experiments.
  • Executes and interprets results independently. · Position requires great organizational and experimental design

Skills. ·
  • Knowledge of the Regulatory guidelines, licensed product lines, routine test methods, and developmental projects related to stability studies. · Demonstrated ability in technical report writing and attention to detail. · Knowledge of site systems (such as SAP) to perform stability study related activities.
  • Able to communicate effectively and promptly supporting department objectives and management decisions. · Collects, reviews, and analyzes stability data.
  • Technical knowledge sufficient to conduct and resolve stability investigations is expected. · Provide support for company's products (marketed and/or developmental). · Provide stability support for the research and development of plasma derived proteins. ·
  • Author stability reports/documents to support the annual product reviews and regulatory submissions under direction of supervisor.

Additional Responsibilities: ·
  • Maintains work areas in accordance with company policies and industrial best practices. · Provides support for research and developmental studies, clinical or commercial manufacturing as needed. · Identifies, implements, and qualifies, as necessary, equipment to meet industrial best practices or achieve compliance with regulatory expectations. Knowledge, Skills, and Abilities: · Ability to set and meet deadlines, multitask, and prioritize personal tasks based on project needs. · Must have strong written and oral communication skills. · Applies scientific principles in problem solving. · Proficient with the use of MS Office software.

Requirements:
  • The Sr Associate Stability Research Scientist II position requires no degree with a minimum of 9 years relevant experience, OR a BS in Life Sciences with a minimum of 5-6 years relevant experience, OR MS in Life Sciences with a minimum of 3 years relevant experience. Strong working knowledge of SAP highly desirable.
  • Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects.
  • Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Repetitive foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand. The ability to listen to and understand information and ideas presented through spoken and written words and sentences.
  • Performs tasks by following a set of written or oral instructions/procedures.

TB_PH

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