WuXi AppTec

Senior Scientist - Process Development, Downstream

Job Locations US-PA-Philadelphia
Job ID
2021-8091

Overview

Works closely with Supervisor in the development and improvement of Downstream processes. Rigorous scientific skills in the general area of Downstream process development and a strong working knowledge of the technical and Good Laboratory Practice (GLP) / current Good Manufacturing Practice (cGMP) compliance requirements for biosafety testing. Prepares Downstream process protocols and Standard Operating Procedures (SOPs), assists in preparing new client protocols, and revises documents as needed. Conducts, schedules, and directs scientific development projects and keeps appropriate records according to and in compliance with GLP, cGMP, Code of Federal Regulations (CFR) and/ or Points to Consider (PTC) guidelines and SOPs.

Responsibilities

  • As assigned by Management, supervises, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining facility's standards.
  • Recommends hire/transfer/promotion/discharge and salary changes and acts on employee problems.
  • Conducts employee performance appraisals in a timely and objective manner.
  • As assigned by Management, acts as Principal Investigator for assigned work and assumes all associated responsibilities.
  • Responsible for appropriately conducting work in accordance with GLPs or cGMPs.
  • Assures that laboratory personnel are following all company SOPs and safety rules.
  • Prepares and revises technical documents (Laboratory Protocols, SOPs, etc.)
  • Assures that batch records and other paperwork are completed according to GLPs / cGMPs and company SOPs.
  • Provides technical information to clients and prospects as needed.
  • Reviews Final Reports for protocols assigned Study Director and participates in critical review and interpretation of test results.
  • Conducts critical review of results and reports data to appropriate internal staff.
  • Reports observations of ongoing tests to appropriate internal staff.
  • Interacts with pertinent internal departments (i.e. Quality Assurance and Project Management) to assure that appropriate testing information is effectively communicated and documented.
  • Effectively interacts with clients to address scientific and related issues.
  • Interacts with subcontractors (as appropriate) and assumes responsibility to ensure timely and accurate completion of all subcontracted assays.
  • Designs and coordinates scientific development projects from inception to completion for the development of new Downstream processes.
  • Generate / organize data for presentations (internal and external)
  • Works on routine assignments per written procedures, where the ability to recognize deviation from accepted practice is required.
  • Normally receives minimal instructions on routine work and detailed instructions on new assignments.

Qualifications

  • 4-7 years of relevant experience or equivalent with a Bachelors’ degree
  • 3-6 years of relevant experience or equivalent with a Masters’ degree
  • 2-4 years of relevant experience or equivalent with a Ph.D. degree
  • Degree with a focus on Biological or Chemical Engineering, Biological Sciences or another science-related topic

 

Knowledge / Skills / Abilities:

  • Experience with the development of downstream bioprocess unit operations such as tangential flow filtration and chromatography.
  • Knowledge of cGMPs is preferred.

 

 

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

 

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

 

WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

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