Lead Manufacturing Biotech AssociateMy 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.