Recruitment Associate @ Baker Finn Recruitment
ADC Biologics Manufacturing Team Lead
As a Team Lead in our clients Biologics division you will assure the long‑term effectiveness of the team: deliver high levels of customer service, ensure quality of product and services, comply with all regulatory requirements, and build an inclusive culture of high performance for the team.
Responsibilities
* Lead and manage the operations team, ensuring adherence to safety, regulatory, and operational requirements.
* Foster a high-performance culture focused on customer service, quality, compliance, financial performance, and inclusion.
* Oversee and execute filling, lyophilization, equipment preparation, formulation, buffer preparation, and support processing activities.
* Prioritize safety and compliance in all activities, conducting regular safety Gembas and promoting a culture of zero safety incidents.
* Review daily work activities to identify and address high‑risk activities.
* Ensure compliance with EHS standards, procedures, and policies.
* Promote a culture of contamination control and adherence to aseptic best practices.
* Effectively deploy and manage team members to meet production schedules.
* Provide daily reporting on the status of operations and support activities.
* Lead, motivate, and direct the manufacturing team to maximize effectiveness.
* Foster team engagement through regular one‑on‑one meetings, clear expectations, feedback, performance reviews, and action plans.
* Develop direct reports through training, challenging tasks, and performance reviews.
* Promote a culture of Right First Time execution, Behavioral Based Safety, Always Audit Ready, and Human Error Reduction.
* Drive operational excellence and achieve key operations targets, including OEE.
* Ensure compliance with safety, environmental, and quality‑related SOPs.
* Collaborate with other Technical Shift Leaders for interdepartmental planning and execution.
* Schedule human and material resources to meet production schedules.
* Utilize management infrastructure tools, trackers, visual management, tier meetings, and Gemba walks.
* Ensure smooth shift handover and communication of performance metrics.
* Identify and supervise critical process steps during your shift.
* Achieve financial targets by improving overhead spend, material usage, and labor efficiency.
* Manage cycle time and identify improvement opportunities.
* Collaborate with program management, supply chain, technical operations, quality, and engineering for effective planning, scheduling, and execution.
* Provide technical guidance and approval for manufacturing batch records.
* Verify and update manufacturing control system transactions accurately and timely.
* Serve as the key technical contact for aseptic fill‑finish activities.
* Support the documentation and investigation of NCRs.
* Interface with QA department for interactions with HPRA, FDA, and other health authorities.
* Lead cross‑functional risk assessments and continuous improvement projects.
* Compile and analyze data to track process performance.
* Provide technical expertise for investigations, root cause analysis, CAPAs, process improvements, and change control reviews and approvals.
* Manage compliance issues that may arise during shifts and ensure adherence to regulatory requirements.
Qualifications
* Degree, Masters or PhD in Life Sciences, Process Engineering, Biopharmaceutical Engineering or Chemical Engineering discipline.
* A minimum of 5 years experience in batch processing, automation, commissioning and validation in a FDA/HPRA regulated industry.
* Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
* Comprehensive understanding of the principles of contamination control and regulatory expectations for aseptic processing.
* Has a technical background in pharmaceutical, biologics, or similar industries.
* Experience of start‑ups and/or new product introductions to bio‑pharmaceutical/pharmaceutical facilities (Biologics Preferred). Must be able to lead & project manage these activities.
* Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality and safety requirements.
* A minimum of 1 year team direct supervisory experience in a team environment.
* Possesses a strong technical knowledge and application of concepts, practices, and procedures.
* Works on problems of complex scope where analysis of situations or data involves multiple competing factors.
* Exercises judgment and advises management as to the appropriate actions.
Senior level
* Mid‑Senior level
Employment type
* Contract
Job function
* Manufacturing, Production, and Science
Industries
* Pharmaceutical Manufacturing
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