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My company shares my
passion for helping to improve human health around the world."
"This is My MedImmune."
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc.
Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.
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Title: Senior Scientist
Location: MD, Gaithersburg - Corporate Headquarters
Req: 02089
Major Duties/Responsibilities
Provide expertise and scientific leadership for design, development and trouble-shooting of the development of formulations for protein therapeutics. Carry out formulation development, optimization, product characterization, and stability studies of proteins. Design experiments to meet specified formulation criteria. Support fill/finish operations and technical transfer to manufacturing for clinical and commercial products. Responsibilities also include application/development of formulation sciences technology to meet development objectives and timelines, as well as preparation and review of regulatory documents (INDs, CTAs, IMPDs) and response to regulatory questions. Experience in the management and development of people is also desired.
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Special Skills/Abilities
Good communication skills, strong interpersonal skills, demonstrated leadership qualities, and the ability to thrive in an interdisciplinary fast paced environment are also an integral part of this position. Demonstrated leadership through project team participation with internal and external alliances
Job Complexity:
Job is complex, requiring a through understanding of the biological and chemical properties of biopharmaceuticals, process development and CMC activities in support of product commercialization. Scientific and technical training in formulation and drug product development, fill-finish operations, biophysics, protein analytical techniques is required. Experience writing and reviewing regulatory documents is essential.
Supervision:
Person is required to have prior supervisory experience. Depending on hiring position, is expected to supervise scientists with BS, MS, and PhD degrees with zero to several years experience in this industry |
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Education:
Ph.D. in Chemistry, Biochemistry, Chemical Engineering or related field with 3-10 yrs relevant industry experience required.
Experience:
Responsible for the design and execution of experiments for protein pre-formulation and formulation development and optimization. Ability to develop analytical and biophysical methods to evaluate protein formulated products. Support reformulation studies, stability studies, technology transfer to manufacturing, and troubleshooting processes at the developmental and commercial level. Experience with calorimetry, HPLC, UV-visible spectroscopy, fluorescence spectroscopy, microscopy, circular dichroism, light scattering, lyophilization, development of modified release formulations (sustained and controlled release), protein modifications (pegylation, conjugation, refolding, etc), device development, GMP fill/finish operations, scale-up, and commercial product support and GLP/GMP are desired. Good communication skills, strong interpersonal skills, demonstrated leadership qualities, ability to work in matrix teams, and the ability to thrive in an interdisciplinary fast paced environment are also an integral part of this position.
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| None Specified |
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