Current Openings at Synexa Life Sciences

Job Purpose:

• The Project Manager (PM) is the responsible person for study delivery, budget management and customer communication for a given portfolio of customer projects. The PM works alongside internal stakeholders to drive delivery, anticipate risks, problem solve and manage budgets, while acting as the primary point of contact for a sponsor/customer, ensuring we deliver against agreed milestones while delivering strong customer satisfaction. A senior Project Manager will additionally act as a mentor to other team members, drive internal process improvements and use experience to manage more complex customer projects. Will act as the backup for the Head of Project Management when needed.

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

Skills and Competencies required:

• General understanding of bioanalytical & biomarkers services to provide support if needed.
• Excellent interpersonal skills
• Ability to drive and motivate internal stakeholders.
• Ability to prioritise tasks and manage time effectively.
• Detail orientated approach and ability to work well under pressure.

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Job Purpose:

• Under direct supervision, uses fundamental concepts, practices, and procedures, together with particular platforms, to perform routine clinical sample processing. These tasks may require the application of established techniques, standard procedures, and criteria in the execution of laboratory testing. To support the laboratory operations team with sample processing and day to-day administration duties.

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.

Skills and Competencies required:

• On-going professional development is strongly encouraged; this may take the form of training, workshops, seminars etc.
• Good knowledge of written and spoken English.
• Proficient in Excel and Microsoft.

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JOB PURPOSE

• The specimen management unit is responsible for the day-to-day management of specimen shipments, specimen handling and specimen logging. Specimens are biological samples collected from either humans or animals and are a valuable resource. Specimens are essential to the biomarker and bioanalytical services conducted at Synexa and are vital to allow us to deliver for our customers.
• The unit is a key part in study delivery and supports Synexa delivery teams to achieve study milestones and accomplish deliverables, while delivering for our customers and supporting the teams to deliver revenue targets.

MAIN AREAS OF RESPONSIBILITY

General

• Provide administrative support as required by the laboratory.
• Perform designated duties in an efficient manner and completing tasks timeously.
• Where required, liaise with procurement and study management teams to arrange couriers for shipment of specimens or compounds/reagents and ensures these are in line with project budgets.

Specimen Management

Pre-Specimen Receipt

• Primary point of contact for external and internal communication related to specimens and Sponsor provided compounds/reagents.
• Confirm timelines for specimen shipments and ensures updated information is visible to the study delivery team via the Odoo planning app.
• Track incoming specimen and Sponsor provided compound/reagent shipments via courier on-line tracking systems and inform the study delivery team regarding any changes in expected timelines or any challenges/issues identified.
• Upon early receipt of shipping manifest for frozen specimens, log specimens and ensure source quality control checks are performed in the study specific sample log sheet, ensuring compliance with quality control method sheets.
• Highlight and resolve any queries related to specimen shipment manifests, requisition forms or equivalent documentation with the relevant CRO and/or Sponsor and ensure the communication is filed (hardcopy and/or electronic) for traceability.
• Ensure up to date sample log sheets are always available for study delivery team usage.

Specimen Receipt

• Ensure adherence to safety procedures upon handling of specimens.
• Receive specimens (as required per site), complete required paperwork and ensure sample log sheets are appropriately updated.
• Where required, file (hardcopy and/or electronic) temperature monitoring data provided by courier and share accordingly with CRO and/or Sponsor upon shipment receipt.
• As required, assist with labelling, sorting and storage of specimens and  Sponsor provided compounds/reagents.
• Upon receipt of fresh specimens, log specimens in a timely manner within study specific sample log sheets and conduct source quality control checks of paperwork ensuring compliance with relevant study documentation. This is time sensitive and critical to be prioritised to allow the study delivery team to perform required specimen testing.
• Review documentation received alongside specimen shipments and verify accuracy. Ensure the specimens meet GCP standards and document any integrity related issues.
• Escalate and resolve queries timeously and upon completion, file (hardcopy and/or electronic) paperwork appropriately.
• Communicate receipt of samples to relevant study delivery team members as well as externally to CRO and/or Sponsor.

Specimen Storage

• Ensure specimens are stored at the correct temperature and storage location is logged in the study specific sample log sheets.
• Alongside relevant laboratory personnel, manage storage location capacity.
• Maintain storage location upkeep by facilitating scheduled sample reconciliations.
• Upon completion of a project, enquire the fate of specimen(s) with the CRO and/or Sponsor and action decision accordingly.
• Based on laboratory requests, retrieve specimens for sample analysis from storage location and following testing, return and store appropriately and update relevant sample log sheets accordingly.

Specimen Administration

• Provide support to the delivery of the lab manual alongside the scientific team to outline specimen collection, processing, storage, and shipment instructions to ensure optimal specimen quality for required testing.
• Assess country specific import/export requirements for biological specimens or Sponsor provided compounds/reagents.
• Where applicable, together with site appointed biological safety officers, assess study specific GMO requirements and support with regulatory application and submissions.
• Where required, complete, submit and track permit applications to approval status from regulatory authorities ensuring no risks to overall study delivery.
• Manage and track permit validity and timeously submit re-applications to relevant authorities where required.

Phlebotomy/Specimen Collection

• Ensure local regulatory approvals are in place to allow donor sample collection to proceed.
• Ensure process specific documentation are completed as per local regulatory guidelines, approvals, and internal workflows.
• In response to laboratory requests, perform required tasks to arrange specimen collection from in-house donor(s) or external network.
• Per site requirement and capacity, manage consumables for specimen collection and as required, place orders via LIMS to replenish stock.
• Where qualified, support with blood draws and other sample collection techniques, following appropriate training and certification.
• Log billable units linked to specimen collection/phlebotomy in Odoo Projects.
• Highlight scope change needs to study management based on approaching out of scope specimen collection requests received from the lab.

EXPERIENCE & QUALIFICATIONS

• Bachelor’s degree or 2-3 years of experience in relevant field of work.
• Ability to oversee sample management activities across multiple studies
• Microsoft Office proficiency including Excel, Word, and Outlook.
• Demonstrated ability to collaborate with a diverse group of lab staff, clinical team members, vendor labs and stakeholders to support delivery milestones.
• ISO, GCP, GLP awareness. 
• Trained Phlebotomist.
• LIMS/LabKey software experience.
• Knowledge of clinical trials and understanding of the role of bioanalytical laboratory assessments in clinical studies.
• Working knowledge of clinical laboratory specimen management.
• Health and Safety knowledge

SKILLS AND COMPETENCIES REQUIRED

• Strong attention to details and quality.
• Excellent written, verbal, organizational and interpersonal communication skills to update stakeholders efficiently and succinctly in English.
• Prioritization skills.
• Ability to multitask.
• Good computer and IT skills.
• Professionalism.
• Eager to grow and develop capabilities.
• Problem solving skills.
• Good time management skills.
• Able to take initiative and work both independently and in a team.
• Administrative skills.
• Innovative.
• Works successfully under pressure.

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Job Purpose:

• Implementation and maintenance of quality assurance at Synexa Life Sciences. Ensuring that procedures are in compliance with GCP, GLP and GCLP.

Main areas of responsibility:

• Responsible for implementing the quality assurance program at Synexa Life Sciences in Cape Town in compliance with GLP, GCP and GCLP. Continuous improvement of quality system. Auditing according to QA SOPs. Global QA harmonization.  

Qualification/Experience:

• More than 5 years experience of GCP and GLP QA work or equivalent
• Applicable natural science
• Good knowledge of the principles of GLP, GCP and GCLP
• Good knowledge of written and spoken English
• Willingness to continuous training and act as trainer for Synexa Life Sciences personnel
• Ability to cooperate and negotiate.
• Persistent and independent way of working
• Knowledge of laboratory SOPs, analytical methods and laboratory functions in general
• Willingness to travel when necessary.
• Working knowledge of LIMS and eQMS systems.

Skills and Competencies:

• To assure that studies are performed in compliance with GCP, GLP and GCLP, and facilities and processes fulfill GCP, GLP and GCLP requirements.
• To follow and implement the South African law, EudraLex, OECD, EMA and FDA guidelines to SOPs.
• To improve of quality system continuously.
• To maintain the audit master list.
• To maintain the CAPA system.
• To maintain the Risk register.
• To write QA SOPs and review other SOPs.
• To participate in computerized system validation team.
• To give GCP, GLP, GCLP and SOP training to personnel.
• To conduct supplier audits. Coordination of authority and sponsor inspections
• To coordinate inspections by the authority and audits of the sponsors.
• Provides guidance and consultation in quality-related issues.

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JOB PURPOSE

• The primary objective of the Procurement and Logistics Officer is to perform logistics and procurement related activities globally within the Synexa group. This includes and is not limited to all goods and services procured, as well as being the central point of contact for logistics related activities.

RESPONSIBILITIES (may include, but not limited to):

• Perform all work as stated by SOPs, Policies, forms and training manuals.
• Receiving all reagents, consumables, equipment and stationery in accordance with company policy and standard operating procedures
• Inspect contents received (verify according to order placed)
• Assist in managing and controlling high risk stock
• Primary liaison to courier companies.
• Organise shipping & liaise with couriers to/from all Synexa sites.
• Maintain good relations with couriers/evaluation and review of couriers
• Receive shipments, check & sign paperwork
• Capture receive dates / ETA dates on order books.
• Receive samples, check & document sample conditions. Label deliveries and allocate to designated areas/staff.
• Maintain general stock levels and attend to weekly consumable stocktake.
• Assist where required with monthly reagent stock take
• Create Material Codes for new materials, and link to suppliers (Order Platform).
• Process goods received (GRV) on inventory platform & assign to projects
• Insert rejected stock on inventory platform. Report irregularities, return stock as needed.
• Assist Sample Management with test collection kit preparations.
• Manage and report courier cost overview.
• The lists of tasks and responsibilities is not exhaustive.
• Should obey a reasonable and legitimate instruction from the manager or a senior employee in authority.

QUALIFICATIONS

• Grade 12 certificate with 5-10 years' experience in field would be essential.
• Diploma or degree in procurement/logistics with 3 - 5 years' experience in related field.

CORE COMPENTENCIES

• Proficient using MS-Word, Excel, Power Point, Outlook
• Organized, attention to detail, able to work alone and part of a team.
• Exhibit timely and professional communication.

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JOB PURPOSE

• Forming part of the Shared Services dept., the Infrastructure officer oversees and performs activities related to equipment & facility management, under the guidance of the infrastructure manager.

RESPONSIBILITIES (may include, but not limited to):

• Read, write, review and update standard operating procedures (SOPs).
• Identify suitable suppliers/vendors based on company needs.
• Implement & maintaining the supplier/vendor database.
• Initiate vendor account application as needed.
• Maintain good relations with vendors/evaluation and review of vendors (approval).
• Review of products and services to suit company needs.
• Coordinate, the procurement, installation, maintenance, qualification, and repairs of equipment and the facility.
• Conduct internal equipment verifications/checks as needed (e.g. temperature alert system).
• Respond to relevant after hour crises (Electricity, water, temperature).
• Request quotes, Purchase Orders.
• Management of Job Cards/Delivery notes related to infrastructure.
• Receive equipment, initiate IQ/OQ/PQ documentation.
• Implement/Maintain an accurate equipment database/Asset register.
• Implement/Maintain accurate service records.
• Implement/Maintain equipment cost/service cost database.
• Preparing purpose/service plans, performing cost analysis and reports for review.
• Support and oversee duties related to the facility staff (Cleaning, Security, Maintenance). Performing minor repairs.

QUALIFICATIONS & EXPERIENCE

• Relevant diploma/certificate in science/procurement/logistics/equipment management
• Two to three years’ work experience in similar role.
• The ideal candidate will have knowledge or experience working with laboratory related materials, products and equipment.
• The ideal candidate will have experience managing equipment and its maintenance.
• Strong background using Microsoft Word, Excel, Outlook, other software platforms.
• Position level will be determined based on skills, education & experience.

CORE COMPENTENCIES

• Excellent leadership, interpersonal, organizational, strong sense of teamwork and multi-tasking skills.
• Experience in managing a small team and their core tasks’ completion is an advantage.
• Ability to handle pressure, interact and function in a highly productive work environment.
• Flexible, adaptable to new tasks and challenges.
• Willing to work afterhours/weekends.
• Ability to work independently, pay attention to detail and think critically is a must.
• Ability to maintain composure and focus on situations of ambiguity and uncertainty.
• Communication skills: should be fluent in English (read, written, spoken).