Job Opportunity

Job Opportunity

Bioprocessing Associate III, MFG USP

Bioprocessing Associate III, MFG USP

United States Posted 2024-06-27

Bioprocessing Associate III

WuXi Biologics 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

The primary responsibility of this role will be to support and deliver on process and equipment operation activities during manufacturing operations. As Bioprocess Associate III, you will be expected to be a subject matter expert in Upstream and in process analytical equipment. Detailed knowledge of the process will be vital to ensure optimum process operations, as well as a high level of understanding of GDP.

Responsibilities:

Assist in driving and maintaining a safety orientated Culture, cGMP/GDP compliant work environment at all times. Guide BPA’s in executing daily activities in a safe, compliant, and efficient manner to maintain production schedules.
Conducts all activities that are in accordance with Company policies & SOPs, WuXi values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, and controlled documents., etc.
Provides co-ordination of scheduling activities and ensures all production rooms are ready for day-to-day operations.
Bioprocess Associate III will also develop and demonstrate individual skills as subject matter experts and are required to display technical leadership by driving improvements and excellence within specific aspects of the manufacturing operation within the shift team.
Bioprocess Associate III are expected to be able to perform all core production tasks in the areas of upstream and all ancillary tasks that related to production activities.
Act as designee for the Senior Bioprocess Associate (BPA) in their absence. Duties in this situation would include but is not limited to attending and chairing meetings, Shift handcover, use escalation process, act as a point of contact for BPA’s during shift.
Liaise with Senior BPA regarding issues which may arise from the production area including highlighting process bottlenecks.
Assist where necessary with the training of colleagues in SOPs, process execution and equipment operation. Support the development of training matrices and ensuring compliance to training requirements.
Assist as a member of the Production team, towards the delivery of production output targets and quality levels on schedule
Carry out all production operations in the assigned area as directed by the relevant Standard Operating Procedures (SOPs) and Batch Records.
Report issues identified during routine operations to Senior BPA and/or Supervisor and perform initial troubleshooting.
Escalation of any deviation from SOPs and batch records and provide assistance with investigation of deviations through the Trackwise system while using scientific, engineering and lean principles.
Liaise with other groups and individuals to ensure planning of tasks are effective and linked into the manufacturing process plan.
Where necessary assist in Facility and Equipment start up and Validation activities.
Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new equipment. Work with cross functional teams to facilitate the development and validation of the Biologics manufacturing facility.
Write, review and revision of area SOPs, Batch Records, Logbooks, On-The-Job Trainings (OJT) etc.
Seek opportunities for Continuous Improvement.
Identify and manage equipment training gaps and requirements.
Provide assistance and/or support to maintenance, engineering, quality or other colleagues as requested.
Will be flexible to take on additional tasks and responsibilities at the discretion of the Senior BPA and Supervisor.
Shift working is required. The shift pattern may be varied according to business requirements and will typically require weekend working
Will be flexible to take overtime work and may work during holidays.
Will act as a role model for the Manufacturing function and also the wider organization in adherence to the WuXi corporate core values and PROUD culture

Qualifications:

2 - 5 years’ experience in biopharmaceutical or pharmaceutical cGMP manufacturing
Demonstrated experience as an SME in a biopharmaceutical operation
Demonstrated career progression is desirable
Previous experience acting as designee to the shift lead role is preferred
A degree in science or chemical engineering is preferred; or equivalent demonstrated experience in the biopharmaceutical industry as specified above.

Knowledge / Skills / Abilities:

Strong demonstrated knowledge in upstream processing is essential
Requires understanding of scientific principles, operational aspects of production equipment and automation control
Demonstrated experience of working in a cGMP/GDP environment
Good level of knowledge and execution of validation protocols is an advantage

Behavioral Competencies

Self-motivated with excellent communication and interpersonal skills
High level of adaptability working in a fast paced environment and champion change
Ability to positively influence and work well with others
Show leadership and support to junior team members
Ability to troubleshoot and strong analytical skills
Comfortable making risk based decisions
Results driven and a proven record of being a high achiever

WuXi Biologics is 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

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