Sr. Scientist, Formulation and Drug Product Development
Company: WuXi Biologics
Posted on: January 11, 2022
Lead formulation and drug product process development (DPD)
development activities including but not limiting to formulation
development, drug product manufacturing process development and
tech transfer, clinical in use compatibility study, and drug
product manufacturing support. Work closely with Analytical
Sciences and other process development and drug product
manufacturing teams to lead formulation development projects.
Responsible for study design, execution and trouble shooting to
meet client project delivery goals. Author technical documents
including SOPs, protocols, study reports, etc. The responsibility
will also include work on DPD Lab start up efforts and support
overall efforts to bring new drug product manufacturing facility
Essential Job Functions
Develop formulation for biological to support product stability for
product development success including study planning, design,
execution and author study report to manage the DPD project life
Develop injectable drug product manufacturing process including
container closure selection, drug product compatibility with
manufacturing process, and provide tech transfer and manufacturing
support including deviation investigation and trouble shooting.
Author technical documents including SOPs, protocols, study
reports, and support regulatory filing.
Play an important role in Formulation/DPD Lab startup efforts
including Lab design, equipment selection/procurement,
documentation preparation and team development.
Apply industry technical knowledge and experience to project work
assigned. Interface extensively in a matrixed environment with
process development, analytical development and Manufacturing teams
for process investigation support, assess new formulation/DPD
technologies, support on-going and upcoming client projects.
accountability for project success and results delivery.
Maintain and support development of internal lab into a safe state
of the art formulation development lab.
Conduct effective Communicate research and development findings
internally and externally to ensure alignment among WuXi Biologics
and with clients.
Performs other duties as assigned.
Ph.D. or M.S in Biochemical/Chemical engineering or related
biotechnology discipline with minimum of 2-5 years of relevant
biopharmaceutical or biotech industry experience.
Candidate must possess strong knowledge and experience in
formulation and drug product process development areas. Understand
current industry practice and scientific reasoning for biologics
product formulation development.
Strong communications skills. Great team player and ability to
build positive collaboration with internal stakeholders, vendors
and clients to achieve alignment and work effectively.
Must work in a self-motivated, multiple tasks, highly flexible,
well-organized and detailed-oriented style. May require some
evening work hours and conference call time to meet global team
Job description does not intend to list all the duties and
responsibilities assigned to this position. Employee holding this
position would be required to perform other job-related
duties/responsibilities based on their expertise and company
Keywords: WuXi Biologics, Elizabeth , Sr. Scientist, Formulation and Drug Product Development, Other , Avenel, New Jersey
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