Job Specification: Analytical Microbiology - Quality Control
The Analytical Microbiology role in Quality Control is a critical position responsible for providing analytical leadership across all aspects of analytical technologies and methods. This role will focus on the development, validation, and lifecycle management of analytical methods for small molecules and therapeutic proteins within the new product introduction and commercial environment. The incumbent will be accountable for generating vital information to support manufacturing objectives, while actively participating in cross-functional teams to ensure compliance with regulatory requirements and manufacturing goals.
Key Responsibilities:
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Analytical Microbiologist Support:
- Conduct comprehensive analysis of raw materials, utilities, facility monitoring, and in-process samples or final products, ensuring adherence to quality and safety standards.
- Lead analytical investigations in case of non-conformance, employing Root Cause Analysis techniques as needed, and implementing necessary countermeasures.
- Develop and validate advanced, robust analytical methods that meet stakeholder requirements.
- Oversee testing protocols in compliance with local procedures and regulatory standards.
- Provide training and mentorship to Quality Control and cross-functional team members.
- Serve as Subject Matter Expert (SME) for specific technologies and business systems within Quality Control.
- Assist in the preparation of Annual Product Reviews (APRs) and Laboratory Periodic Review Reports (PRRs).
- Foster strong relationships with Global Regulatory Affairs and contribute to regulatory submissions.
- Support and participate in self-inspections and audits related to cGMPs as defined by Health Authorities and regulatory bodies.
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Leadership/Site Management:
- Support management decisions and strategies proactively.
- Exemplify high-performance standards and desired behaviours within the Quality Control team.
- Influence external partners and stakeholders to address critical issues and achieve desired goals.
- Participate in relevant technical forums and contribute effectively.
Pre-Requisites:
- Profound expertise in analytical/biochemical/microbiological techniques, including Quantitative PCR, Endotoxin, Bioburden, and rapid Bioburden techniques.
- Excellent laboratory techniques prioritising safety.
- Strong independent and collaborative problem-solving skills.
- Self-motivated and efficient in producing high-quality work.
- Meticulous attention to detail in all aspects of work.
Educational/Experience Requirements:
- BSc/MSc in Analytical Sciences (Chemistry, Biochemistry, Microbiology) with a minimum of 5 years of pharmaceutical experience; or PhD/Post Doctorate level in Analytical Science (Chemistry, Biochemistry, Microbiology) with 3-5 years of recent bench experience in a laboratory environment.
Additional Skills/Preferences:
- High learning agility and adaptability to achieve desired outcomes.
- Strong written and oral communication skills.
- Innovative approach to problem-solving and solution discovery.
- Conflict resolution abilities and promotion of effective decision-making among team members.
Key Attributes:
- Business Knowledge: High performance, initiative-driven, and proactive in work approach.
- Learning Agility and Curiosity: Adaptability to ambiguity and problem-solving skills.
- Positive Influence: Reliable, performance-driven, and open to feedback.
- Relationship Builder: Skillful in establishing and maintaining relationships across all organisational levels.
- Ability to Lead People: Proficient in leading and motivating teams.
- Communication: Effective communication skills in both one-on-one and group settings.
- Decision Making: Decisive with a demonstrated ability to gather and analyse information for optimal decision-making.