Job Opportunity

Job Opportunity

Bioprocessing Associate l, MFG DSP (Contractor)

Bioprocessing Associate l, MFG DSP (Contractor)

United States Posted 2024-05-01

Senior Bioprocessing Associate

Job Summary

The primary responsibility of this role will be to support and deliver on process and equipment operation activities during manufacturing operations. As a Senior Bioprocessing Associate, you will be expected to be a subject matter expert in Downstream purification and in process analytical equipment. A key responsibility of this role will be to coach and mentor Technicians (Bioprocessing Associate). Detailed knowledge of the process will be vital to ensure optimum process operations, as well as a high level of understanding of GMP/GDP requirements.

Essential Duties and Responsibilities

Provides co-ordination of scheduling activities and ensures all production supplies are available for day-to-day operations.
Organise daily activities and work with Bioprocessing Associates in executing those activities in a safe, compliant, and efficient manner to maintain production schedules.
Act as designee for the Supervior in their absence. Duties in this situation would include but is not limited to attending and leading meetings, time off coverage, use escalation process, act as a point of contact for Bioprocessing Associates during shift.
Senior Bioprocessing Associates will perform all core production tasks in the areas of downstream and all ancillary tasks.
Write, review and update of area Standard Operating Procedures (SOPs), On the Job Training (OJT’s), Production Batch Records (PBRs), Logbooks, Training Competencies and Work Instructions.
Carry out all production operations in the assigned area as directed by the relevant SOPs and Manufacturing Batch Records. Perform initial troubleshooting of issues identified during routine operations. Adhere to Right First Time (RFT) principals at all times.
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.
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.
Lead and actively participate in shift handovers. Liaise with Supervisor regarding issues which may arise from the production area including highlighting process bottlenecks.
Where necessary assist in any facility, equipment start up and validation activities.
Provide input on equipment installation, operation and troubleshooting to support introduction of new products into sustaining operations. Work with cross functional teams to facilitate the development and validation of the Biologics manufacturing facility.
Senior Bioprocessing Associate will also develop and demonstrate individual skills as subject matter experts and are required to display technical leadership by acting as ‘Champion’ to drive improvements and excellence within specific aspects of the manufacturing operation within the shift team.
Assist in driving and maintaining a safety orientated Culture, cGMP/GDP compliant work environment at all times.
Liaise with other groups and individuals to ensure planning of tasks are effective and linked into the manufacturing process plan.
Use Lean Tools as part of daily operations (Standard Work, 5S, TPM, Method 1, 2 etc.) to optimize efficiency and drive the culture of Continuous Improvement (CI) and Zero Defects.
Support Equipment Design and risk assessments as per requirements.
Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule delivery, EHS metrics, Production Plan, Overall Equipement Effectiveness (OEE), compliance and team training.
Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.
Due to the start-up nature of the project there will be an expectation for flexibility and an ability to take on varied tasks at short notice not covered extensively within this job description.
Conducts all activities that are in accordance with Company policies & SOPs, WuXi Biologics values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc. Advise management of non-conformance issues and opportunities for (CI).
Shift working is required. The shift pattern may be varied according to business requirements and will typically require weekend working.
Identify and manage equipment training gaps and requirements.
Perform all duties in accordance with GMP requirements, SOPs and controlled documents
Will be flexible to take on additional tasks and responsibilities at the discretion of the Supervisor
Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi Biologics corporate core values and PROUD culture.

Person Specification

Technical Competencies

Comprehensive knowledge and experience of relevant cGMP, safety and environmental regulations within the biopharmaceutical industry

Experience

Demonstrated experience as an SME in a biopharmaceutical operation
Experience of operating automated control systems such as CCP, Unicorn or similar systems is desired
Demonstrated career progression is desirable
Previous experience acting as supervisor or designee is preferred
Experience in coordinating shift activities and escalation of issues to ensure all manufacturing processes are adhered to

Knowledge

Strong demonstrated knowledge in downstream 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
Experience in lean 6 Sigma tools in standard work and 5S are an advantage
Good level of knowledge and execution of validation protocols is an advantage

Qualifications

Certificate, Diploma, Degree in Science, Engineering or related field or equivalent experience in the biopharmaceutical industry is essential

Behavioural 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

Onerous requirements

This role may initially be day based to support onboarding and training but will migrate to a permanent shift schedule as per business requirement

Delegation of Responsibilities

When absent from the site duties and responsibilities will be delegated to the following designates:

Job Title: MFG Supervisor

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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