As a Application Laboratory Manager, you will be the point-of-contact and subject matter expert for all laboratory related activities and will partner with cross-functional teams including R&D, Commercial, Operations, Compliance, Quality and Regulatory to manage the BioProduction Application lab and facilitate client demonstration and support any development activity, internal or external.

Duties & Responsibilities

• Manage the application lab which serves to all current and prospective Bioproduction customers in SEATw region, execute timelines, report progress using clear metrics, demonstrate role model leadership, think outside the box and be a champion for the business
• Use your comprehensive knowledge of Bioprocess to help customers on their trial/Scale-up runs or any assigned custom development project using Thermo Fisher’s Bioproduction offerings including Single Use Technology, Cell Culture, Purification and Pharma Analytics
• Actively participate in establishing deliverables, meet goals, and communicate effectively in a multi-team environment
• Construct and verbally deliver technical presentations that articulate the complete, hypothesis driven experimental path, all relevant outcomes including technical challenges, successes, failures and the key conclusions, including recommended next step
• Contribute to the team as a player-coach with thoughtful guidance and feedback in the related areas of scientific expertise
• Communicate with departments as a technical representative to assist in process improvement, customer inquiries, and staff training as needed
• Work closely with global product management to capture product requirements effectively and translate into project deliverables
• Work closely with SEATw commercial and Technical team to effectively complete the project deliverables
• Perform supply logistics which includes forecasting and procuring materials for R&D demand and inventory control.
• Manage laboratory day-to-day operations including lab organization (5S), laboratory facilities, lab accessibility and security, and safety protocols.
• Ensure adherence to regulatory and quality requirements to be in compliance with lab certifications
• Perform equipment life cycle asset management duties including maintaining instrument calibrations and validations, servicing laboratory equipment, and managing a validated equipment and asset database.
• Participate in site audits as subject matter expert in the areas of lab asset management, equipment servicing and related Quality Management System (QMS) processes.
• Drive the improvement and development of lab management
• Ensure the safety of the own and of others when performing high-risk procedures.
• Review laboratory protocols, maintaining laboratory standard operating procedures (SOP) and risk assessment (RA) documentations.
• Ensure all equipment in the laboratory setting meets safety standards.
• Manage, train and supervise laboratory staff.
• Resolve technical problems in consultation with respective SEATw technical team
• Implement new programmes, methodologies and laboratory equipment when required.
• Tracking progress of projects and collaborations.
• Lead planning and policy of the laboratory;
• Access lab instruments/equipment and facility, make recommendation and improvement
• Sustained evaluation and awareness of competitor activities & innovations within the marketplace in general & ensuring that relevant information is circulated within the organization

Minimum Requirements/Qualifications:

• Master’s degree in Chemical Engineering, Biomedical Engineering, Biotechnology or related field with a minimum of 8-10 years of related industry experience with 2 or more years of prior lab management experience. A PhD will be a plus
• A highly competent and motivated individual with industry or equivalent experience in developing bioprocesses for mAb’s, Vaccines, Cell therapy etc
• Demonstrated knowledge in BioPharma development and manufacturing
• An excellent operational understanding of Bioprocess and Analytical instruments like Single-Use bioreactors, fermenters & mixing vessels, Chromatography, PCR, Sequencing instruments etc

• Ability to work effectively in a matrixed environment, managing complexities while being flexible enough to adapt to a changing environment
• Ability to conduct independent research and development work with clear deliverables and meeting commitments, guide technical areas, be able to make decisions in designing, performing, analyzing, and presenting experimental results
• Availability to travel to visit relevant scientific conferences and visit collaborators as needed