Scientist
Company: Alpha Consulting Corp.
Location: Gaithersburg
Posted on: May 28, 2023
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Job Description:
SCIENTIST GAITHERSBURG, MD Project Description: Members of the
tech transfer function are responsible for transfer of upstream
processes from process development into clinical and commercial
manufacturing. They work closely with the process development
scientists (located in the US and UK), clinical/commercial
manufacturing organizations, CMOs, and QA to ensure appropriate
scale up and transfer of clinical and commercial processes to GMP
manufacturing production. Routinely transfer multiple projects as
upstream tech transfer representative. This includes Fit-to-plant,
process risk analysis, timely generation of tech transfer
documentation, batch record review/approval, technical
collaboration with receiving organizations, campaign monitoring and
support, performance analysis and interpretation, investigation
support, campaign summary report authoring, and routine
presentations to cross-functional teams and management . Builds and
maintains relationships with partner groups . Proactively addresses
risks/issues to avoid non-conformances and enable efficient
transfers . Effectively communicate and collaborate in a matrix
team setting to implement technical solutions . Write technical
reports and deliver presentations . Contribute to the improvement
of the tech transfer business processes through idea generation and
implementation activities . Required Skills: A bachelor's or
master's degree in an engineering or scientific discipline. A focus
in a process engineering field (e.g., chemical, or biochemical
engineering) is strongly preferred. The candidate must have
relevant industry related experience (BS 5-8, MS 2-5). Cell culture
tech transfer and/or development experience . Hands on experience
with bioreactors (bench, pilot, or production scale) . Fundamental
understanding of upstream unit operations such as mixing, inoculum
expansion, bioreactor, centrifugation, and filtration. Knowledge of
GMP manufacturing principles and documentation . Excellent written
and verbal communication skills . Experience with data and
statistical analysis . Experience with primary clarification via
continuous centrifuge . Identify and solve complex manufacturing or
bioprocess technical problems with limited data in a timely manner
. Demonstrated ability to defend a technical position . Experience
in a cGMP-regulated environment and/or large-scale bioprocessing
laboratory . Fermentation or viral based production experience .
Skilled in conducting process transfer/process
development/technology development projects . This 12+ month
position starts ASAP. Please E-MAIL your resume (attachment to
email) with rate and availability to Rose: Rose@alphaconsulting.com
ALPHA'S REQUIREMENT #23-00829 MUST BE ELIGIBLE TO WORK IN THE U.S.
AS AN HOURLY W2 EMPLOYEE
PDN-990b15c6-f697-40d0-a63b-8c62af5aaea1
Keywords: Alpha Consulting Corp., Washington DC , Scientist, Other , Gaithersburg, DC
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