Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.)

Job Description

Job Responsibilities

Lead, mentor, and encourage the team to achieve flawless execution of tasks, strictly adhering to safety and biosafety standards.Manage resources effectively to ensure smooth operations and successful implementation of objectives.Coordinate team workflows to meet production schedules and maintain outstanding standards of cleanliness and equipment validation.Implement cGMP regulations and verify the accuracy and currency of all procedural documentation.Coordinate aseptic operations with logistics, quality control (QC), and quality assurance (QA) teams.Facilitate team meetings, address operational challenges, and provide solutions to your supervisor.Actively participate in risk analyses related to processes, doses, and containers.

Team Leadership

Ensure initial and ongoing training for team members to perform their tasks competently.Serve as a role model and mentor, encouraging a collaborative and inclusive team environment.Motivate and manage the team, addressing conflicts and promoting autonomy and responsibility.

Documentation Management

Participate in drafting and verifying production plans and protocols.Review and verify completed reports and batch records, ensuring compliance with CAPA and deviation management protocols.Collaborate with QA to validate and implement Standard Operating Procedures (SOPs) and other relevant documents, ensuring adherence to documentation formats, deadlines, and priorities.

Performance Reporting

Communicate effectively with internal and external collaborators, including subcontractors.Establish and uphold performance metrics, guaranteeing that weekly reports are current.Engage in necessary meetings to fulfill the role's requirements.

Qualifications and Experience

Master's degree or engineering background in a scientific field or equivalent experience.At least 3 years of proven experience in an industrial (pharmaceutical) environment and team management.Proficiency in English (both oral and written).Expertise in GMP, GDP, and quality system implementation.Strong operational, writing, and leadership skills.Ideally, experience with SAP and MS Office Suite (Excel/Word/PowerPoint).