Laboratory Manager

Sterling Chemical Malta Ltd. is an Italian pharmaceutical company specialising in the development, optimization and manufacturing of high-quality generic Active Pharmaceutical Ingredients (APIs). Our purpose is to enhance people’s lives by developing innovative solutions to enable new treatment routes for critical diseases. Sterling’s mission is to ensure the highest levels of excellence both in its business approach as well as in the development of highly skilled employees.

We are currently looking for a Laboratory Manager who will be responsible for overseeing the quality control activities within Sterling Chemical Malta Ltd. This role ensures that all products meet regulatory and company standards for safety, efficacy, and quality.

The Laboratory Manager is part of the Quality unit and collaborates with cross-functional teams to maintain compliance with Good Manufacturing Practices (GMP), regulatory requirements, and company business and policies.

Key Responsibilities:

• Leadership and Management
  
  
  
  • Lead and mentor the Laboratory team, including chemists, analysts, and technicians.
  
  
  • Develop and implement training programs to enhance staff expertise.
  
  
  • Assign tasks / projects, monitor performance, and manage workloads to ensure timely completion of objectives.
  
  
  
  


• Quality Control Operations
  
  
  
  • Oversee the design, development, and validation of analytical methods for raw materials, intermediates, and finished products (Drug Substances).
  
  
  • Oversee the testing of raw materials, in-process samples, finished products, and stability studies.
  
  
  • Ensure proper documentation and adherence to standard operating procedures (SOPs).
  
  
  • Review and approve analytical data and reports for accuracy reproducibility, and regulatory compliance.
  
  
  • Investigate and resolve quality-related issues, deviations, and out-of-specification (OOS) results.
  
  
  • Troubleshoot analytical methods and optimize protocols as necessary.
  
  
  • Generate technical reports, validation protocols, and method development documentation.
  
  
  • Present analytical findings to stakeholders and cross-functional teams.
  
  
  • Support stability studies and impurity profiling as per procedures in force.
  
  
  
  


• Regulatory Compliance
  
  
  
  • Ensure laboratory operations comply with regulatory standards, such as GMP, FDA, EMA, and ICH guidelines.
  
  
  • Support regulatory submissions by providing analytical data, summaries, and responses to regulatory queries.
  
  
  • Participate in audits and inspections, providing documentation and addressing findings as needed.
  
  
  • Maintain knowledge of current regulatory requirements and industry best practices.
  
  
  
  


• Process Improvement
  
  
  
  • Identify opportunities to optimize QC processes, improve efficiency, and reduce costs.
  
  
  • Implement and validate new analytical methods and technologies.
  
  
  • Collaborate with R&D, Quality Assurance (QA) and manufacturing teams to support drug development and production to ensure smooth transitions of new products or processes.
  
  
  • Identify opportunities to improve existing methods, workflows, and productivity.
  
  
  • Provide technical expertise during technology transfer, process scale-up, and troubleshooting.
  
  
  • Stay updated on industry trends, scientific advancements, and regulatory changes.
  
  
  
  


• Documentation and Reporting
  
  
  
  • Ensure accurate and complete recording of all laboratory data, as per GMP requirements.
  
  
  • Prepare and review quality reports, metrics, and trends for senior management.
  
  
  • Manage the laboratory’s inventory, including chemicals, reagents, and equipment.
  
  
  
  

Qualifications:

• Education and Experience
  
  
  
  • Master’s or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
  
  
  • Minimum 7-10 years of experience in Analytical Research or Quality Control, with at least 3 years in a managerial role within the pharmaceutical industry, preferably API manufacturing.
  
  
  
  


• Skills and Competencies
  
  
  
  • Strong knowledge of analytical techniques such as HPLC, GC, LC-MS, NMR, FTIR, UV-Vis, and wet chemistry.
  
  
  • Proficiency in GMP, GLP, and regulatory requirements.
  
  
  • Strong understanding of ICH, USP, and regulatory guidelines for method development and validation.
  
  
  • Proficiency in scientific software (e.g., OpenLab) and data interpretation.
  
  
  • Excellent problem-solving and decision-making skills.
  
  
  • Strong leadership, communication, and interpersonal skills.
  
  
  • Ability to manage multiple priorities and work under tight deadlines.
  
  
  
  


• Work Environment:
  
  
  
  • Office setting, occasionally exposed to chemicals and laboratory equipment.
  
  
  • Occasional travel for training, audits, or regulatory inspections.
  
  
  • This role is critical to ensuring the production of safe, high-quality pharmaceutical Drug Substances that comply with regulatory requirements.
  
  
  
  

What We Offer:

• A competitive salary.


• A welcoming and inclusive environment.


• A state-of-the-art working facility.


• Medical check-ups.


• A culture where teamwork is the priority.


• A meaningful job where all employees contribute towards improving people’s lives.


• A challenging role with an innovative company.

Interested applicants are to send their CV to the Human Resources department via the apply button below.
Sterling Chemical Malta Limited - KMP-95893