Job Title – QC Sr.Scientist-I, Project
Work Location – Cranbury, NJ
WuXi Biologics is a is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our
PROUD culture of Passion, Reward, Opportunity, Unity, and Determination. WuXi Biologics offers exciting job opportunities and
careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies
Job Summary
Supports Quality Control clients related integrated, standalone or related QC department projects and ad hoc work. Work closely and collaborate with external departments such as PM and CMC leaders with QC internal testing functions to ensure smooth orderly management of QC methods and timelines. Responsible for overall QC projects deliverables and meeting clients’ expectations regarding projects’ completions and IND filings. Responsible as the function lead or functional sponsor to managing specific QC projects’ communications and deliverables to clients. Demonstrates strong oral and written communication skills and actively contributes to project training, reports/COAs/COTs generation and documentation.
Responsibilities:
- Supports in overseeing the Quality Control clients related integrated, standalone or related QC department projects.
- Lead multiple matrix teams involving Analytical development, QC testing teams to establish and accomplish method transfer and Qualification Strategy.
- Attends regular internal or external QC projects clients’ meetings to understand each clients’ specific requirements and needs.
- Able to work and collaborate closely with external departments such as PM and CMC leaders and communicate certain needs to QC internal testing functions to ensure smooth orderly management of QC methods and timelines.
- Provides key input and recommendation of clients’ data review or investigation process. Serves as lead for client discussions regarding project quality or investigations/deviations.
- Strong Technical and Scientific knowledge of protein-based assays, including HPLC, CE electrophoresis, ELISA, PCR and/or potency methods.
- Ensure compliance to training, testing, documentation and general lab management requirements for Industry Standards and/or Regulations
- Participate in preparation of project-related audits when needed.
- Effective multi-tasking skills and time management required.
- Ability to evaluate technical data and record data accurately and legibly.
- Able to conduct or support clients’ site visits routinely or ad hoc basis.
- Supervises staff and manages staff’s deliverables to meet expectations
- Ability to work effectively as part of a team and exhibit effective interpersonal skills.
- Support any required QC documentations such SOP, protocols, final reports, investigations, and deviations when needed.
- Conducts critical review of results and reports data when needed.
- Supports in proposal drafting, providing pricing support.
Qualifications:
- Bachelor or advanced Graduate degree in Biology, Cell Biology, or equivalent field.
- A least 5+ years of relevant experience or equivalent for Bachelors’, 3+ years for Master’s in the Quality Control or related field or equivalent experience.
- Candidate must possess extensive knowledge and experience in analytical and QC operations of pharmaceutical industry, understand current regulations and industry trends of biologics product development, characterization and manufacturing testing requirement including cGMP, ICH, EMA, FDA, and other global compendia regulations and guidance.
- Solid track record of working experience in quality control operation to support clinical and commercial scale manufacturing product testing and regulatory IND/BLA filing.
- He or She should have demonstrated ability of problem solving and decision making.
- Ability to rapidly pivot between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives.
- Project management experience is preferred.
The salary range for this position is 72,800-116,500
The 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.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender