Lead Manufacturing Biotech Associate

Lead Manufacturing Biotech Associate

My client is a seeking a Lead Manufacturing Biotech Associate to join their team an initial contract basis working in a cutting-edge, multi-product biotech facility where decisions are made at the point of data. As a Lead Manufacturing Biotech Associate, you will guide and support the manufacturing process, fostering a culture of safety, quality, and continuous improvement.

Key Responsibilities:

Execute and oversee manufacturing operations to achieve production goals. Guide teams in shift work, batch progression, and documentation following cGMP standards. Conduct sampling, in-process testing, and maintain production records. Review and author technical documents, ensuring compliance with good manufacturing practices. Provide coaching on documentation accuracy and safety protocols. Identify and address compliance, safety, and process deviations; support investigations and corrective actions. Lead cross-functional teams on continuous improvement projects and site initiatives. Troubleshoot equipment, manage maintenance schedules, and minimize downtime. Act as a point of contact for issue resolution and support task execution.

General Competencies:

Strong leadership and collaboration skills with a focus on continuous improvement. Ability to coach and develop team members into effective operators and subject matter experts. Excellent problem-solving and troubleshooting abilities.

Technical Skills:

In-depth knowledge of cGMP manufacturing, Lean methodologies, and automated systems (MES - PAS X, SAP, Delta V). Familiarity with plant equipment, safety, GMP, environmental, and validation procedures. Experience in hands-on and instructor-led training.

Qualifications:

Bachelor's degree in science, engineering, or a related field (Level 8) or equivalent with at least 5 years' experience in a GMP-regulated environment. Minimum of 3 years in Biopharma with experience in biologics manufacturing preferred. Proven track record in a regulated industry.

Additional Information:

This role is site-based and involves working shifts on a 24/7 basis.

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