Description

Who We Are

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

QC Shift Lead – In-Process Control - Shift

Closing date: 3rd January 2025

Exciting opening in a newly 5S certified Analytical lab within QC In-Process team at BioMarin.  This is a very diverse role which encompasses all the in-process testing (both analytical and microbial) for the Drug substance and Drug product facilities on site.  In addition, the in-process team support testing for all incoming raw materials and testing of the incoming packaging materials for the pack lines.

Due to the fast-paced nature of the in-process group the team is a shift-based team, operating a 4 cycle shift pattern.

QC In-Process are a high-performing, team-based group, where colleagues are flexible, multi-skilled and empowered to make decisions. QC In-Process operates to an extremely high standard of quality and compliance. 

A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.

Reporting to the QC Manager, the primary role of the QC Shift lead is to lead the shift to provide support to internal customers by providing quality testing and delivering results in accordance with GMP standards.

There are no direct reports as part of this role.

QC Shift lead Roles and Responsibilities

Lead:

• Stay connected to the schedule – Manage changes as needed.
• POC for QC for the MFG floor and rest of site out of hours.
• Drive the schedule. Troubleshoot and escalate delays appropriately.
• Troubleshoot and escalate testing issues, safety, and quality issues.
• Drive good practices in respect to alarm response on the shift
• Attend face to face handover with incoming/outgoing shift lead.
• Authorise Sys Suit Retests and Raise/support LIR/dev investigations.
• Provide morning update at 08:30 meeting.

Organise:

• Owner of the shift to shift in-person handover process.
• All non-routing tasks (strangers – scanning TR’s, authorising results for MFG etc.) on the shift come through shift lead who is responsible for reviewing, challenging, and delegating these.
• Approve safety permits and delegate approval to shift where possible.
• Where required, assign meeting attendance on the shift.
• Attend, and contribute to the organization of, quarterly shift lead meetings
• Ensure low stock/shortages are escalated in a timely manner.

Develop:

• Guide training with days team for that shift to cover most critical gaps first.
• Assign time for projects (CI’s, RCARs etc.) where time is free in schedule.
• Mentor new starts on shift.
• Provide input to recruitment decisions and shift structure with Sr’s/TL/MGR.
• Identify proxy to step in when shift lead is out.

Other responsibilities include:

• Testing of all sample types (this is the majority of the job and it is a still a very lab based role) on time in full that come to the team.
• Perform primary review of QC raw data and trend results
• Prepare protocols, summaries, and reports
• Draft/Update QC SOPs
• Act as technical resource (SME) and train other analysts in areas of expertise
• Evaluate results against defined acceptance criteria
• Conduct and document laboratory investigations to completion
• Maintain the laboratory in an inspection-ready state
• Interact directly with regulatory agency inspectors during audits when required.
• Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary
• Other Duties as assigned.
  
  

Desirable Skills:

Excellent communication skills both written and verbal
Proven knowledge/experience of the workings in the QCIP team in BioMarin is desirable.
Customer focus; takes personal responsibility for speed; quality and accuracy of delivery
Self-motivated and ability to work under pressure
Team Leadership – active participation team development and continuous improvement including robust handover shift to shift, standard work and 5S
Successful track record in achieving goals as part of a team within a growing, dynamic environment
Demonstrated adaptability and flexibility to support a growing organization

Demonstrated leadership of a team

Education:

BSc in a scientific/engineering discipline with 5+ years (MSc with 3+ years) of relevant (cGMP) laboratory experience.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.