MS&T Scientist III
Company: Renaissance Services
Posted on: November 16, 2022
All qualified applicants will receive consideration for employment
without regard to race, color, sex, sexual orientation, gender
identity, religion, national origin, disability, veteran status,
age, marital status, pregnancy, genetic information, or other
legally protected status.
As MS&T Scientist III, the successful candidate will work on
significant technical/scientific project activities to execute
strategies and technical solutions that meet Renaissance's and
their client's needs and expectations through broad expertise. The
successful candidate will be expected to maintain a high level of
expertise within their field and engages in creation of processes
and equipment design for clinical, scale up, and/or registration
batches, including technology transfer of projects from client
sites. Assume technical ownership of a given product across the
various stages of development and commercialization in coordination
with other functional areas.
The MS&T Scientist III will be responsible for designing,
leading, and executing studies to support product and process
optimization and automation, investigation on deviation and root
cause analysis; technology transfer activities, and product
characterization studies, and any other activities required by the
--- Utilize and apply knowledge of basic scientific principles,
theories and concepts to develop solutions to problems of moderate
to high complexity. Lead multidisciplinary teams in developing and
--- Perform site transfer activities to Renaissance from business
partner locations and provide scientifically sound development
--- Develop and optimize manufacturing processes for clinical,
registration and commercial scale batches for sterile and
--- Prepare and review Master Batch Records for
experimental/engineering, registration, scale-up and process
--- Prepare robust pharmaceutical/process development reports and
other CMC documentation for regulatory submissions and represent
Renaissance as SME during internal/external regulatory audits.
--- Use statistical process control and other statistical tools for
comparison and hypothesis testing. Apply engineering,
pharmaceutical sciences or materials sciences fundamentals to model
the product and process to solve complex technical problems.
--- Evaluate and implement advance technologies for process
evaluations and optimization (e.g., Process Analytical Technology,
electronic batch records etc.)
--- Review and provide inputs for validation master plans,
validation protocols, validation reports, continued process
verification (CPV) plans and statistical sampling plans, among
other important strategic documents.
--- Acts as internal/external Subject Matter Expert (SME) for drug
product and process related technical issues and provide technical
support to Formulation, Manufacturing, and Quality.
--- Identify potential root causes of variation and deviations
using a systematic approach. Expertise in use / application of
variety of problem-solving tools e.g. Ishikawa, Kepner-Tregoe (KT),
five-whys, etc. and lead technical Deviation write-ups and CAPA
--- Work closely with process engineering team to develop robust
user requirement documents for process equipment including
manufacturing and packaging.
--- Provide technical input to management team regarding site
capacity to evaluate new projects.
--- Lead and guide other scientists/associates in process
development and manufacturing.
--- Experience in cGMP manufacture of commercial or late phase
clinical products. Experience with technology transfer and scale up
--- Familiarity with statistical process control (SPC), complex
data analysis, mathematical modeling, and optimization software
(like MiniTab, JMP, etc.) is a must.
--- Knowledge and experience in cGMP, risk assessment and
investigation tools and techniques.
--- Able to work on multiple projects simultaneously. Familiarity
with project management concepts is preferred.
--- Proficiency with Quality by Design (QbD) concepts and design of
--- Demonstrated ability to provide scientific input and make
decisions to resolve problems with minimal supervision.
--- BS/MS/Ph.D. in pharmaceutical sciences/chemistry (or related
field like organic, physical, biochemical, chemical engineering)
with 6+ years (BS,), 4+ years (MS) or 2 years (Ph.D.) industrial
Keywords: Renaissance Services, Lakewood , MS&T Scientist III, Other , Lakewood, New Jersey
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