GMP Team Lead Manufacturing and Quality Control

Job Title: GMP Quality Control Team Lead

Location: Hoofddorp, NL

Contract: 12 Months

Hours: 40 hours per week

Shift Pattern: Weekend shift once every 4 weeks

Salary: €68,000 per annum

Note: EU passport holder required, no VISA sponsorship available for this role.

Overview: i-pharm consulting is collaborating with a global biopharmaceutical company that specializes in pioneering cancer immunotherapies, with a primary objective of achieving rapid, enduring responses and alleviating the burden of chronic care. We are currently seeking motivated individuals to join their team in Hoofddorp, NL as Team Leaders on their manufacturing and QC departments.

Department Description:

As a Team Lead in GMP and Quality Control, you will be an integral member of a newly established team that values diversity and a wide range of experiences. This is a collaborative environment that is dedicated to saving lives by progressing towards a cure for cancer. You will report directly to the Senior Manager of Manufacturing.

Your Responsibilities:

We are in search of an efficient and capable Team Lead for GMP manufacturing / Quality Control, responsible for overseeing a team of manufacturing operatos/ QC Lab Techs within a commercial pharmaceutical setting.

Key responsibilities include:

• Supervising day-to-day operations of a commercial cell therapy manufacturing facility adhering to cGMP standards.
• Building and nurturing a cohesive team through training, coaching, performance evaluations, and recognition of direct staff.
• Developing Standard Operating Procedures (SOPs), Master Production Records (MPRs), and Standard Production Records (SPRs) for routine biologics manufacturing equipment and processes.
• Executing production schedules and resource allocations in alignment with operational plans.
• Ensuring the precise execution of process steps corresponding to the specific phase or stage of operation.
• Monitoring processes, utilizing databases, documents, and spreadsheets for business reporting needs.
• Reviewing completed manufacturing documentation in accordance with compliance standards and established timelines.
• Identifying issues, conducting root cause analysis, proposing process enhancements, and effectively communicating with senior management.
• Collaborating with external vendors and senior leadership.
• Participating in cross-functional project teams as required.
• Initiating corrective actions through change control procedures.

Your Profile:

Education:

• Bachelor's degree in biology or a related field (or equivalent experience), preferably accompanied by at least 5 years of staff supervision experience.

Knowledge/Experience:

• Proficiency in team formation and leadership, with the ability to train entry-level personnel.
• Previous experience in cell culture, highly preferred.
• Familiarity with Current Good Manufacturing Practices (cGMPs).
• Sound understanding of processes, systems, and equipment troubleshooting, providing solutions to senior management.
• Adequate knowledge of electronic quality systems.

If you're intrigued by this role or want to learn about other opportunities, please get in touch with Manpreet Bhullar at mbhullar@i-pharmconsulting.com or call UK:+44 (0)20 7551 0802 / NL:+31 20 809 0665.