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Sr. Scientist, Formulation and Drug Product Development

Company: WuXi Biologics
Location: Avenel
Posted on: January 11, 2022

Job Description:

Job Summary
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 alive.

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 cycle.
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.

Requirements
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 timezones.

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 business needs.

Keywords: WuXi Biologics, Elizabeth , Sr. Scientist, Formulation and Drug Product Development, Other , Avenel, New Jersey

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