Manufacturing Lead Associate (Tech Ops)

Role Summary

The individual in this role will be responsible for supporting the operations in a cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role is primarily responsible for performing daily manufacturing operations and will also support additional manufacturing responsibilities.

Responsibilities

• Provide routine on-the-floor support and execute operations.
• Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients.
• Assist the supervisor leading daily operations and resolving floor issues.
• Assist the supervisor to ensure all operational duties are completed each day/shift.
• Assist in development and implementation of GMP SOPs related to Manufacturing Operations.
• Maintain production facilities at a high standard of cleanliness and organization.
• Perform equipment maintenance and calibrations as required.
• Maintain appropriate level of training for assigned responsibilities.
• Identify and report risks in the manufacturing areas that could negatively impact the quality of patient therapies.
• Ensure timely review and closure of electronic batch records, exceptions, deviations.
• Assist with CAPA and change controls as needed.
• Be a team player, offer assistance, and respond well to requests for help from team members.
• Use strong communication and build relationships.
• Demonstrate technical acumen, operational understanding, and GMP compliance.
• Support operational excellence initiatives.
• Promote a culture of safety and GMP compliance.
• Identify opportunities for continuous improvement.
• Lead team huddles.

Qualifications

• Minimum 8 years’ experience in GMP biopharmaceutical operations preferably with experience in cell therapy, mammalian cell culture, and/or microbial fermentation.
• Experience with quality management systems (e.g. Deviations, CAPAs, Change Management).
• Experience with electronic systems such as MES and ERP.
• Familiar with regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, and viral vectors for clinical phase therapies.
• P wen track record in cGMP manufacturing operations, including producing therapies safely and right the first time.
• Fast learner, adaptable, and excellent cross-collaboration and inter-personal skills.
• The desire and ability to work in a fast-paced, start-up environment.

Skills

• Strong communication and relationship-building
• GMP compliance and safety mindset
• Operational excellence and continuous improvement orientation
• Technical acumen in manufacturing operations

Education

• BSc degree in a relevant field (e.g., biochemistry, chemical engineering, bioengineering, or related scientific field)

Additional Requirements

• Physical requirements: ability to confirm visual information in the environment (batch records, SOP steps, equipment parameters, and material/product status). A vision test may be required; use of corrective lenses is acceptable.
• Stand and step over a gowning bench (12–24 inches) and aseptically don head-to-toe non-sterile and sterile gowns.