Vacancies Available at Synexa Life Sciences

Main areas of responsibility:

Laboratory & Scientific Duties

• Take on responsibility as Analytical Project Manager (APM) on clinical projects.
• Oversees the work of others team members (Lab technicians/Research Associates/Scientists)
• Assists in capacity and reagent planning and inventory as needed.
• Develop and validate genetic/genomic assays to meet the company or client’s needs as per SOPs and latest guidelines.
• Sample analysis and reporting.
• Reporting and presenting genetic data generated to clients.
• Draft guidance and reporting documents for projects (lab manual, VPP, MDP, SAP, SAR etc).
• Trouble shooting when required: doing literature research and sharing solutions.
• Sharing of knowledge and providing input on training and scientific development of junior staff.
• Use of Odoo platform to complete timesheets and planning.
• Involvement in pre- and post- contracted phase (eg. reagent plans, quote review, protocols, out of scope work, etc).

Ad-hoc

• Write and/or review SOPs and forms.
• Oversee the work of others (RA/other Scientists) – assist in capacity planning as needed.
• Provide training and share insights regularly.
• Support in achieving Synexa revenue targets and reaching monthly targets.
• Study lead on 3+ studies.
• Direct communication with a client
• Assess systems being used and identify areas for improvement.

Qualification/Experience required:

• A minimum level of a PhD degree in genetics, or 5+ years of experience in a relevant field of work is required.
• On-going general International Organization for Standardization - ISO, Good Clinical Practice (GCP), Good Clinical Laboratory Practice - GCLP and Good Laboratory Practice - GLP awareness training needs to be provided to all staff.
• Experience in pipette handling, following protocols and using basic equipment (e.g. centrifuges, biosafety cabinets, incubators). The ideal candidate should have significant prior experience working with PCR and sequencing instruments.
• Experience in genetic data analysis, database searching, unique primer design and optimisation.
• Previous work experience in a relevant field.
• Working within a good practice (GxP) and/or Good Clinical Laboratory Practice (GCLP) accredited environment.

Skills and Competencies required:

• Strong project leadership skills with a proven track record of leading projects to timely completion.
• Excellent organisational skills with the ability to prioritise multiple tasks.
• Ability to work both independently and in a team, with a proactive approach to resolving technical challenges.
• Excellent interpersonal, communication and presentation skills.
• Proficient in the use of Microsoft Word, Excel and PowerPoint.
• Ability to review and assimilate new information rapidly and effectively.
• On-going professional development is strongly encouraged; this may take the form of training, workshops, seminars etc.
• Good knowledge of written and spoken English

Genetics:

• Excellent practical knowledge of genetic and molecular biology techniques, including microbiology and virology.
• Expert knowledge and use of molecular biology equipment such as next generation sequencers, digital and quantitative PCR instruments.
• Experience working as part of a multi-disciplinary scientific team, with a strong academic research background. 
• Expertise in various genetic assays including nucleic acid isolations, genotyping, microbiome sequencing, DNA sequencing, multiplex analysis, absolute quantification, relative quantification and gene expression.)
• Proven experience in genetic data analysis and working knowledge of analytical software platforms.

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Main areas of responsibility:

• Performs routine clinical sample analysis as per in-house standard operating procedures (SOP´s) and validated protocols under the guidance of Scientists.
• Ensures clear audit trails by performing quality control of all information and data generated.
• Reporting data generated and assisting in the transcription checking of data generated.
• Assists with multiple projects in a fast-paced laboratory environment.
• Management, monitoring and ordering of consumable stock thereby ensuring that sufficient reagents are available to perform assays.
• Stock takes (this includes stock management on a Laboratory information management system (LIMS)).
• Strong adherence to regulatory compliance and safety requirements involving good clinical laboratory practices (GCLP), SOPs, Health & Safety policies, and other related documents.
• Assumes the responsibility of Chief Analyst on assay methods.
• Odoo timesheet and planning accurately and efficiently.

Ad-hoc

• Writes and/or reviews/validates SOP´s, standard working procedures (SWP´s), documents, forms, and spreadsheets.
• Documents and updates the installation, operation, and performance qualifications (IQ/OQ/PQ) of equipment e.g., new equipment, preventative maintenance (PM), services etc.
• Ensures that equipment being used for assays are fit for purpose and are not used outside of service dates.
• Updates equipment service databases as well as service labels and IQ/OQ/PQ´s (equipment custodian).
• Performs set-ups, start-ups, and verification of various analysers (e.g., electrochemiluminescence analysers, microplate readers, flow
• cytometers etc.) and laboratory equipment (e.g., centrifuges, pipettes, timers, and thermometers etc.).
• Performs daily good housekeeping (GHK) duties.
• Completes and maintains relevant documentation related to clinical trials such as overview documents, sample logistics tracking forms, worksheets, and method sheets etc.
• Ensures correct, timeous, and documented receipt of all sample as well as reagent deliveries including proper storage thereof (this includes locating and drawing of samples and reagents when needed).
• Assist with the training of other staff members in company procedures.

Qualification/Experience required:

• A minimum level of vocational training as a Medical/Biomedical laboratory technician (i.e., National Certificate in clinical pathology from recognized institution) or 2-3 years of experience in the equivalent work or in a relevant technical role.
• On-going general International Organization for Standardization (ISO), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) awareness training needs to be provided to all staff. The job holder needs to ensure that he/she is up to date with the available training.
• Experience in pipette handling, following standard protocols and using basic equipment (e.g., centrifuges, biosafety cabinets, plate washers and incubators).
• The ideal candidate should have prior experience working with analysers e.g., electrochemiluminescence analysers, microplate readers, Flow cytometers etc.
• Working within a good practice (GxP) and/or Good Clinical Laboratory Practice (GCLP) accredited environment.

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Main areas of responsibility:

• Ensures that all samples are processed according to the sample analysis plan as well as timely delivery of study deliverables.
• Assists in the laboratory with tasks associated with Method Development and Validation, under the supervision of the APM/ Senior Scientists.
• Is able to work on multiple platforms with minimal supervision.
• Works as the main analyst on multiple studies at any given time.
• Is able to troubleshoot methods and instruments on a technical level
• Ensures that the Odoo planning app is accurately and efficiently updated
• Generates revenue by processing clinical samples and performing Method Development and Validation work as per Method Sheets
• Provides support to up to 10 team members and oversees their work and training
• Ensures study teams work with minimal errors (data and paperwork) and supports members in executing preventative actions
• Ensures the upkeep of Study Files and documentation
• Identifies and document deviations within the study
• Assumes a leadership role in training team members on specific aspects of multiple studies, methods and company procedures
• Oversees and drives the performance of team members while setting an example for others; is a strong driver of teamwork
• Manages equipment which includes being custodian of a range of equipment and identifies issues, including troubleshooting.
• Ensures reagent orders are within the budget of quote, is involved in reagent planning and management
• Supports the writing of reports and documents for projects (Lab Manuals, Validation Phase Plans, Method Development Plans, Sample Analysis Plans, Sample Analysis Reports etc.)

Ad-hoc

• Creates customer satisfaction by flawless study execution and oversight on selected studies and shows good verbal communication with key players.
• Strong adherence to regulatory compliance and safety requirements, involving good clinical laboratory practices (GCLP), SOPs, Health & Safety policies, and other related documents.
• Assesses systems being used, identifies gaps and identifies areas for improvement.
• Writes, maintains and reviews SOPs and forms.

Qualification/Experience:

• A minimum level of vocational training as a Medical/Biomedical laboratory technician (i.e., National Certificate in clinical pathology from recognized institution) with 4-5 years of experience in the equivalent work or in a relevant technical role.
• On-going general International Organization for Standardization - ISO, Good Clinical Practice - GCP and Good Laboratory Practice - GLP awareness training needs to be provided to all staff. The job holder needs to ensure that he/she is up to date with the available training.
• Experience in pipette handling, following protocols, and using basic equipment (e.g., centrifuges, biosafety cabinets, incubators). Can independently troubleshoot equipment-related problems and perform multiple assays.
• Working within a good practice (GxP) and/or Good Clinical Laboratory Practice (GCLP) accredited environment.
• The ideal candidate should have prior experience working with analysers (MSD, Epoch), Flow cytometers, PCR.
• Someone who has a strong understanding of the day-to-day operations within a laboratory and who has a strong ability to lead, train others, and influence their productivity.

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Main areas of responsibility:

General

• Prepares overall study plan and ensures compliance with standard processes, policies and procedures to allow project execution.
• Anticipates risks within study, identifies mitigation strategies, continually monitors and implements corrective actions as required.
• Drives project/study completion and continued project progression.
• Manages delivery in line with customer budget.

Communication

• Primary point of contact for internal and external communication for study delivery.
• Works with internals stakeholders to ensure agreed study delivery timelines remain on track.
• Provides clear, concise, professional communication to keep customer/sponsor updated with study specific progress, timelines, and budget management.
• Responds to customer emails within 24 hours.
• Shares progress updates as required to ensures all members remain engaged and aligned.
• Follows internal escalation process for resolution of challenges identified within projects.

Timeline management

• Liaises with internal stakeholders to ensure appropriate resource allocation to allow timely delivery of milestones, as per contract.
• Where possible, accelerates delivery of project milestones for timely closure of project(s).
• Is the point of contact to explain timelines and next steps to the customer/sponsor.

Management of budget

• Manages delivery of the project within the contracted budgeted.
• Updates the customer/sponsor of any additional budget requirements and works with the assigned APM and Business Operations to develop quote updates if scope changes.
• Has a thorough understanding of study budget(s) and prepares revenue forecast, monthly invoices, and end of study reconciliation.

Qualification/Experience required:

• Bachelor’s Degree in life sciences or related field 
• Knowledge of Good Clinical Laboratory Practice
• 5+ years global project management experience
• 5+ years experience of clinical trials and drug development
• Highly experienced in complex budget management

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MAIN AREAS OF RESPONSIBILITY

Planning & reporting

Preparing service plans, performing cost analysis and reports for review.
Managing the coordination of minor repairs, assess/improve workflow of business activities.
Ensures processes are executed as cost-effective and efficient as possible (i.e. automation / identifies areas of optimisation of processes).

Facilities & Infrastructure

Responsible for maintenance and facilities staff (i.e. effectiveness, efficiency, job satisfaction, remuneration, career and skill progress, annual performance management).
Respond to relevant after hour crises (Electricity, water, temperature).
Act as administrator to temperature monitoring system.
Support and oversee duties related to the facility staff (Cleaning, Security, Maintenance).

Safety and Compliance

• Develop and implement equipment maintenance schedules, including calibration and regular servicing, to ensure the equipment remains in optimal working condition.
• Arrange for repair or replacement of faulty equipment.

Vendor Management

• Identify suitable suppliers/vendors based on company needs relating to responsible areas.
• Coordinate the procurement, installation, maintenance, qualification, and repairs of equipment and the facility.
• Maintain good relations with infrastructure and facilities related vendors.

Equipment management

• Maintain equipment database (Implement/Maintain accurate service records as applicable)
• Management of Job Cards/Delivery notes related to infrastructure.
• Implement/Maintain equipment cost/service cost database.
• Supporting the lab with Gas supply, receipt, storing and connect.
• Receive equipment, initiate IQ/OQ/PQ documentation.
• Conduct internal equipment verifications/checks as needed (e.g. temperature alert system).

Quality related

• Read, write, review and update standard operating procedures (SOPs).
• Participate in audits and related corrections as per SOP.

Security

• Implement security measures to safeguard sensitive research data, materials, and equipment.
• Control access to the laboratory.
• Manage the external third-party security team to ensure the safety of the laboratory complex and staff working on site.

Documentation & Record Keeping 

• Maintain records of equipment maintenance, safety inspections, and laboratory modifications.
• Ensure that documentation is organised and accessible for audits and regulatory compliance.

Emergency Response Planning

• Develop and maintain emergency response plans for various scenarios, including fires and other safety incidents.

QUALIFICATION AND EXPERIENCE

• A diploma in a related scientific field. 
• Experience in a Laboratory environment.
• B.Sc. +
• Two or more years’ experience in a laboratory environment / infrastructure related