Scientist II, Drug Product Development and Manufacturing

Scientist II, Drug Product Development

WuXi Biologics Cranbury, New Jersey, United States (On-site)

Job Title - Scientist ll, Drug Product Development and Manufacturing

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

Drug product development and manufacturing (DP) is seeking a scientist to join our department. The successful candidate will be expected to work as part of a team that focuses on the activities including but not limited to formulation development, drug product manufacturing process development and technical transfer, clinical in use compatibility study, and clinical drug product manufacturing. Work closely with analytical sciences (AS) and process development and drug product manufacturing teams to lead drug product process development and manufacturing projects. Responsible for study design, execution and troubleshooting to meet client project deliverables. Author technical documents including SOPs, protocols, study reports, etc.

Responsibilities

• Adhere to WuXi Biologics’ quality system and work under cGMP to manufacturing clinical drug products.
• Execute drug product manufacturing processes development and tech transfer.
• Execute liquid formulation development and fill/finish process scaled down model.
• 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.
• Support protein analyses and biophysical characterization of protein drug products in conjunction with analytical science team and process development team.
• Apply scientific knowledge and experience to assigned projects. 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.
• Communicate effectively on the findings of research and development internally and externally to ensure alignment among WuXi Biologics and with clients.
  
  
  
  

Preferred:

• Drug product process development experience with large molecules for parenteral administration
• Development and characterization of aseptic fill and finish operations including freeze/thaw, compounding, mixing, sterile filtration, filling, stoppering, visual inspection,
• Manufacturing experience of biologics drug product in clinical settings.
• Experience in biophysical characterization of the biologics drug products.
  
  
  
  

Qualifications:

• PhD with 0-2 years of experience in Pharmaceutics, Pharmaceutical Sciences, Pharmaceutical Chemistry or Chemistry Candidate must possess knowledge in formulation, and drug product process development areas. Understand current industry practice and scientific reasoning for biologics drug product process development.
• Be qualified to work in cGMP environment. With hands-on experience with Vanrx Robotic filling system.
• 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 time zones.
• The job description does not intend to list all the duties and responsibilities assigned to this position. Employees holding this position are required to perform other job-related duties/responsibilities based on their expertise and company business needs.
  
  
  
  

The Anticipated salary for this position is $70,000-110,000

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 identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability