**Job Title:** BioPharma Senior Manufacturing Analyst
We are seeking a skilled and experienced BioPharma Senior Manufacturing Analyst to join our team. In this role, you will have the opportunity to plan and organize all aspects of operations and manufacturing technicians to execute a schedule defined by Supply Chain and/or other customers.
The successful candidate will ensure that all activities in the area comply with EHS and quality regulations. You will provide support to Manufacturing Technicians and Technical Shift Leads (TLSs) in achieving the overall business goals and objectives for the site.
You will communicate regularly with alternate shifts and other Departments such as Microbiology Lab, Maintenance, QA, Contamination Control Operators (CCO's), and others.
Why you should apply:
* This is an excellent opportunity to work in a world-class manufacturing operation with a strong culture of continuous improvement and innovation.
* We strive to develop solutions that improve health outcomes and dramatically improve people's lives.
* Our client is developing the capability to produce all its medicines, ensuring continuity of supply of our medicines as they expand internationally.
Key Responsibilities:
* Plan and schedule activities for Manufacturing Technicians, ensuring that all aspects of the area are fully staffed and any constraints are managed appropriately or escalated to the TSL.
* Schedule activities in a multi-product facility, switching between product campaigns seamlessly.
* Ensure all activities are completed in line with regulatory (QA & EHS) and corporate requirements.
* Triage and troubleshoot equipment issues as they arise, escalating to maintenance.
* Actively lead and/or participate in Root Cause Analysis of non-conformances, equipment issues, environmental monitoring out-of-limits, and complaints as they arise. Engage other Departments to resolve issues as required.
* Using skills matrix for Operations Team, drive cross-training to ensure performance of team and individuals.
* Lead and support continuous improvement initiatives as required to support the overall goals of Core 1.
* Promote and develop a culture of Right First Time.
* Provide leadership at Tier meetings to ensure focus is maintained on key objectives for the shift.
* Compile metrics as required for Perfect Index and others.
* Review and contribute to technical documents, including protocols, reports, and batch manufacturing documents.
* Other duties as assigned.
Requirements:
* Bachelor's degree in a related scientific field is required; and/or a minimum of 4 years' experience in aseptic manufacturing environment.
* Must have experience in aseptic techniques, formulation, aseptic filling of sterile product, and/or visual inspection of Parenteral products.
* Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
* Comprehensive understanding of contamination control principles.
* Possess strong technical knowledge and application of concepts, practices, and procedures.
* Good interpersonal skills to develop working relationships with people at all levels.
* Previous people management experience is desirable.