Job Rotation

4 weeks ago

Fremont, United States BI Fremont Full time

The Manufacturing MSAT WT organization is responsible for the plan, design, and execution of new product introduction (NPI) activities to support the GMP production of biopharmaceutical drug substances including process scale-up. Additionally, the MSAT team performs on-the-floor support, process monitoring, troubleshooting, process optimization, and data analytics for all campaigns. Moreover, the MAST team is responsible for data wrangling/verification for each PPQ campaign and FDA filling.

**Capacity **40% for 6 months

**Duties & Responsibilities**:
**This individual will be responsible for **planning and execution of assigned deliverables (i.e., Pre-campaign activities) needed to support biopharmaceutical production in the West Train. This individual will co-lead/support campaign readiness activities specifically to the MSAT group and perform on-the-floor troubleshooting during the campaign.

This individual will work with matrix cross-functional teams on a routine basis to develop and track execution plans including pre-campaign activities, risk evaluations, change control, deviation investigation, and CAPA implementations. This individual will drive the execution to meet the endorsed timeline and scope. This person will identify, mitigate, and escalate risks of the campaign to ensure timely delivery of the high-quality product.

This person will assume ownership of operational tasks of the MSAT WT team such as setting up meetings, defining agendas, assigning action items, and summarizing meeting minutes.

**Requirements**:
**Eligibility Requirements**:

- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.**Desired Skills, Experience and Abilities**:

- Strong process and equipment knowledge of biopharmaceutical manufacturing facilities.
- Experience with LIMS, DeltaV, PI historian, BioMes, SAP, and GoTrack.
- Strong team player with good communication skills and a can-do attitude.
- Possess exceptional planning and organizational skills.
- Ability to collaborate closely with cross-functional teams, drive executions, and ensure timely delivery of all required deliverables.
- Knowledge of GMP, compliance & Regulatory requirements.
- Extensive knowledge of MS Office, including MS Project, databases, etc. Willing to provide support outside of normal business hours as needed.**From this development opportunity, the individual will develop **the technical skills and scientific knowledge to resolve manufacturing issues, make data-driven recommendations, and drive project implementation and process improvement. The individual will become familiar with all the required campaign readiness activities before the start of production in the B3 GMP facility. The individual will gain the technical knowledge for all the unit operations, learn troubleshooting strategies, and resolve the issue(s) encountered during production. The individual will build a strong relationship with cross-functional teams and develop his/her technical skills in deviation investigations, CAPA implementations, and data analytics.

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