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BioPharma Senior Manufacturing Analyst, Mayo
Team Horizon is seeking a BioPharma Senior Manufacturing Analyst for our client based in Mayo. In this role, you will organize and plan all aspects of operations and manufacturing technicians to execute a schedule defined by Supply Chain and/or other customers. You will ensure compliance with EHS and quality regulations. The role involves supporting Manufacturing Technicians and Technical Shift Leads (TSLs) in achieving site goals, with regular communication with other departments such as Microbiology Lab, Maintenance, QA, and Contamination Control Operators (CCOs).
Why you should apply:
* This is an excellent opportunity to join a world-class manufacturing operation with a strong track record of delivering high-quality medicines globally.
* The company fosters a culture of continuous improvement and innovation to enhance health outcomes and improve lives.
* The client is expanding its manufacturing capability to ensure supply continuity as it grows internationally.
What you will be doing:
* Plan and schedule activities for Manufacturing Technicians, ensuring proper staffing and managing constraints or escalating them to the TSL.
* Schedule activities in a multi-product facility, switching seamlessly between product campaigns.
* Ensure all activities comply with regulatory (QA & EHS) and corporate standards.
* Triages and troubleshoots equipment issues, escalating to maintenance as needed.
* Lead or participate in Root Cause Analysis of non-conformances, equipment issues, environmental monitoring out-of-limits, and complaints, engaging other departments to resolve issues.
* Use skills matrix for Operations Team to drive cross-training, ensuring team and individual performance.
* Lead and support continuous improvement initiatives to support core site goals.
* Promote a culture of Right First Time.
* Provide leadership at Tier meetings to focus on key shift objectives.
* Compile metrics for performance indices such as the Perfect Index.
* Review and contribute to technical documents, including protocols, reports, and batch manufacturing records.
* Perform other duties as assigned.
What you need to apply:
* Bachelor’s degree in a related scientific field or a minimum of 4 years’ experience in an aseptic manufacturing environment.
* Experience with aseptic techniques, formulation, sterile product filling, and/or visual inspection of Parenteral products.
* Knowledge of cGMP and regulatory requirements in the pharmaceutical industry.
* Understanding of contamination control principles.
* Strong technical knowledge and application skills.
* Good interpersonal skills for working with diverse teams.
* People management experience is desirable.
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