Bio-Processing Shift Lead
Posted on Sep 24, 2021 by Elevate Direct
Bio-Processing Shift Lead
Reporting to the Manufacturing Associate Director in MFG suite 6 or 7, the Shift Lead will initially be responsible for supporting all operational readiness activities to ensure the facility design meets end user requirements. Upon successful commencement of commercial operations, the role will evolve to leading a team of highly trained professionals in the manufacture of biological products in adherence to the highest standards of quality and regulatory compliance. The Shift lead will be responsible for the recruitment, development, and retention of the team in order to consistently deliver on the specific KPI's and also to meet with the expectations of our customers.
Leadership & People Management
You will be responsible for leading Upstream or Downstream bioprocesses. This may involve overseeing cell culture, solution prep, purification and drug substance filling activities, managing and leading a large team of Bioprocess Associates (BPA) on shift
Manages shift activities with production needs, prioritizes tasks and assigns resources accordingly.
Makes technical decisions and escalates issues promptly.
Manages all training and team communications including assignment and prioritization of work activities.
Delivery of objectives is a key element of the role and managing performance management and development of direct reports.
The shift lead will lead all employee relation matters and ensure challenges and opportunities are addressed proactively and in a timely basis.
Will play an important role in the execution of the business plans while ensuring cross functional collaboration and leadership execution.
Responsible for schedule adherence metric on shift; drives performance to ensure throughput and changeover targets are met.
Responsible for emergency procedures, safety systems, safety performance, communication and behaviours on the shift.
Leads team safety audits and walk downs as required and advocates a strong safety ethos with all employees.
Actively participates in HAZOPs and other risk assessments as required.
Reports and leads the investigation of safety or environmental incidents on the shift and records, reports and resolves/escalates unsafe conditions or near misses that are observed. Acts as authoriser for the Permit to Work in manufacturing during normal day shifts and in all areas across site in the out of hours.
Compliance and RFT:
Ensures that the plant and equipment is operating in a compliant manner and that all activities are conducted to meet GMP regulations, site and corporate quality standards and any additional regulatory requirements as required.
Reports and investigates batch deviations or quality issues on the shift and escalate issues promptly.
Oversees the review of completed documentation and is responsible for RFT on shift.
Conducts any checks, inspections or audits necessary.
Responsible for housekeeping and audit preparations in assigned areas.
Manage training for their shift team and own the respective training plan.
Write, review, revise and approve of area SOPs, Batch Records, Logbooks & Training Competencies
Technical Transfer and Project Support
Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products.
Where necessary, assist in Facility and Equipment start up and Validation activities.
Seek opportunities for Continuous Improvement through the use of Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5S, Method 1, 2 etc.)
Experienced in supporting a Manufacturing department and building a team in a greenfield' context of similar size and scale is desirable.
Strong level of supervisory/leadership experience in the pharmaceutical/biopharma industry in a manufacturing leadership role is desirable.
Extensive experience in leading teams, supporting the continued development of employees, motivating and engaging them to achieve their potential.
Experience driving high employee engagement through positive employee relations.
Must have experience in leading or participating in medium/large projects and possess demonstrated project management capabilities.
In-depth knowledge of relevant cGMP, safety and environmental regulations.
Expert knowledge and experience of automated processes, equipment, and single use technologies relevant to bio-pharmaceutical industry is advantageous.
Excellent knowledge of the documentation standards and protocols in a pharmaceutical/biopharma manufacturing environment.
Possess strong knowledge of recombinant protein manufacturing techniques and methods, which include bioreactor culture and harvesting, liquid solution preparations, and purification and formulation of recombinant protein is desirable.
This is an excellent opportunity to join an established company as it expands its Irish operations. This is a permanent Full time opportunity and comes with excellent salary and full benefits package.