Careers at SONA
Biosciences

Position Summary:

We are seeking a highly organized and experienced Biorepository Project Manager to oversee and manage biorepository projects. This role involves coordinating the collection, storage, and distribution of biological samples for research purposes, ensuring compliance with industry standards and regulatory requirements. The Biorepository Project Manager will be responsible for managing timelines, budgets, and resources, while working closely with cross-functional teams to ensure the efficient and accurate management of biospecimens. The role also requires strong leadership, attention to detail, and the ability to drive continuous improvements in biorepository operations.

Key Responsibilities:

• Manage the day-to-day operations of biorepository projects, ensuring timely and accurate collection, storage, and distribution of biospecimens.
• Coordinate with research teams, clinical teams, and external partners to facilitate the smooth execution of biorepository activities.
• Develop and maintain project plans, including timelines, milestones, and resource allocation.
• Oversee the implementation and adherence to quality control procedures for biospecimen management to ensure the integrity and compliance of all stored samples.
• Ensure compliance with regulatory requirements, including GxP, FDA, HIPAA, and other relevant guidelines.
• Monitor and manage project budgets, ensuring resources are allocated efficiently and expenses are controlled.
• Identify and address project risks and challenges, proactively implementing solutions to maintain project timelines and quality standards.
• Prepare and present progress reports, project updates, and scientific findings to senior management and stakeholders.
• Lead and mentor a team, fostering collaboration and continuous professional development within the biorepository unit.
• Assist with audits and inspections, ensuring biorepository operations meet all regulatory and operational standards.

Requirements:

• Years of Experience : 3-5 years of experience in project management, preferably within biorepository, clinical research, or healthcare settings.
• Education : Bachelor’s or Master’s degree in Life Sciences, Biology, or a related field.
• Skills :
  • In-depth knowledge of biospecimen management, including collection, storage, and distribution.
  • Familiarity with regulatory standards (GxP, FDA, HIPAA) and quality management systems.
  • Strong project management skills, including budgeting, scheduling, and resource management.
  • Excellent leadership, communication, and interpersonal skills, with the ability to collaborate effectively across departments.
  • Ability to manage multiple projects simultaneously while maintaining attention to detail and meeting deadlines.
  • Strong problem-solving skills and the ability to adapt to evolving project needs.
  • Proficiency with project management software (e.g., MS Project, Asana, Trello).
  • Proficient in Microsoft Office Suite, Google Workspace, or related tools.
  • Strong communication skills in English (both written and verbal).

Skills:

• Biorepository Operations and Management
• Biospecimen Collection, Storage, and Distribution
• Regulatory Compliance (GxP, FDA, HIPAA)
• Project Management and Resource Allocation
• Budget and Risk Management
• Leadership and Team Collaboration
• Quality Control and Process Optimization
• Data Management and Reporting
• Attention to Detail and Time Management
• Proficiency in Microsoft Office Suite, Google Workspace, or related tools

Position Summary:

We are looking for a highly skilled Clinical Research Associate to join our team overseeing biospecimen collection programs. The CRA will be responsible for monitoring and managing the collection of biological samples for research purposes, ensuring compliance with regulatory standards, and maintaining effective communication between research sites and project teams. The role requires attention to detail, strong problem-solving skills, and the ability to ensure the integrity and accuracy of all biospecimen collection activities.

Key Responsibilities:

• Monitor and manage biospecimen collection processes at research sites, ensuring compliance with study protocols and regulatory guidelines.
• Collaborate with clinical teams to ensure accurate and timely collection, handling, and transportation of biological samples.
• Train site staff on proper biospecimen collection, storage, and documentation procedures.
• Conduct site visits, audits, and ensure proper documentation of sample chain of custody.
• Ensure that biospecimen collection meets quality standards, including compliance with GxP and other applicable regulations.
• Address and resolve issues related to biospecimen collection and ensure all deviations are documented and managed appropriately.
• Provide regular updates on the status of biospecimen collection and ensure timelines are met.
• Maintain accurate records and databases related to biospecimen collection and tracking.

Requirements:

• Years of Experience : 2-3 years in clinical research or biospecimen collection management.
• Education : Bachelor’s degree in Life Sciences, Clinical Research, or a related field.
• Skills :
  • Strong knowledge of clinical research regulations (GxP, FDA, ICH).
  • Excellent organizational and communication skills.
  • Proficient in managing and tracking biospecimen collection.
  • Attention to detail and ability to follow complex protocols.

Position Summary:

We are seeking a Quality Assurance Manager with expertise in biospecimen collection programs to ensure that our processes meet the highest standards of quality and regulatory compliance. This role will oversee quality control measures and lead audits for biospecimen collection, storage, and transportation, ensuring all activities adhere to required guidelines.

Key Responsibilities:

• Develop, implement, and monitor quality assurance processes for biospecimen collection, ensuring compliance with industry regulations and standards.
• Lead audits of biospecimen collection activities and report findings to senior management.
• Implement corrective actions to address non-conformities in biospecimen handling, storage, and documentation.
• Ensure proper training of staff involved in biospecimen collection on quality assurance standards and best practices.
• Review and update Standard Operating Procedures (SOPs) related to biospecimen collection.
• Maintain records of audits, deviations, and corrective actions, ensuring regulatory compliance.
• Conduct risk assessments and provide solutions to improve quality in biospecimen collection programs.

Requirements:

• Years of Experience : 4-5 years in Quality Assurance, with experience in biospecimen collection or clinical research.
• Education : Bachelor’s or Master’s degree in Life Sciences, Quality Management, or a related field.
• Skills :
  • Deep knowledge of GxP, FDA, and HIPAA regulations.
  • Strong audit and quality management experience.
  • Leadership and training skills for quality initiatives.

Position Summary:

We are looking for a Kitting Specialist to join our biospecimen collection program team. The role involves preparing and assembling kits for sample collection, ensuring proper labeling, inventory management, and compliance with all regulatory requirements.

Key Responsibilities:

• Assemble and prepare kits for biospecimen collection, ensuring that all components are accurate and meet regulatory standards.
• Label and pack kits for distribution to research sites, ensuring compliance with biospecimen collection protocols.
• Manage inventory of kitting materials and order supplies as needed.
• Coordinate with logistics teams to ensure timely delivery of kits to research sites.
• Conduct quality control checks on assembled kits to ensure all components meet required specifications.

Requirements:

• Years of Experience : 2-3 years in kitting, logistics, or biospecimen management.
• Education : Bachelor’s degree in Life Sciences, Supply Chain, or a related field.
• Skills :
  • Experience with biospecimen collection kit assembly and inventory management.
  • Knowledge of GxP, GMP, and biospecimen regulatory standards.
  • Strong organizational and communication skills.

Position Summary:

We are seeking a Logistics Manager to oversee the transportation, storage, and distribution of biospecimens. This role ensures timely and compliant delivery of biospecimens from collection sites to laboratories or storage facilities.

Key Responsibilities:

• Manage the logistics of biospecimen collection, including transportation, storage, and tracking of samples.
• Ensure timely and secure delivery of specimens to appropriate destinations while maintaining compliance with regulatory standards.
• Develop and optimize transportation and storage protocols for biospecimens.
• Oversee the coordination of biospecimen shipments and resolve any issues related to logistics.

Requirements:

• Years of Experience : 4-5 years in logistics, with experience in biospecimen management or clinical operations.
• Education : Bachelor’s degree in Logistics, Supply Chain Management, or Life Sciences.
• Skills :
  • Knowledge of biospecimen transportation regulations (GxP, FDA).
  • Strong logistics and supply chain management experience.
  • Leadership skills to manage logistics teams and workflows.

Position Summary:

We are looking for a Site Operation Specialist to manage the operations and compliance related to biospecimen collection at research sites. The role involves overseeing site processes, coordinating with clinical teams, and ensuring proper sample collection, storage, and documentation.

Key Responsibilities:

• Oversee biospecimen collection processes at research sites, ensuring compliance with all protocols and regulatory standards.
• Coordinate training for site personnel on biospecimen collection and handling procedures.
• Conduct regular site visits to ensure compliance and quality in sample collection.
• Resolve any issues related to biospecimen collection and provide solutions for continuous improvement.

Requirements:

• Years of Experience : 3-4 years in clinical operations or biospecimen management.
• Education : Bachelor’s degree in Life Sciences, Clinical Research, or a related field.
• Skills :
  • Strong understanding of biospecimen collection processes and compliance.
  • Ability to work directly with clinical sites to ensure adherence to protocols.
  • Strong organizational and problem-solving skills.

Position Summary:

We are seeking a Business Development Manager to grow and expand our biospecimen collection programs. The role involves identifying new opportunities, building relationships with potential clients, and overseeing the development and implementation of biospecimen collection strategies for new business.

Key Responsibilities:

• Develop and execute strategies to expand biospecimen collection services.
• Identify potential clients and partners in the healthcare, pharmaceutical, and research sectors.
• Negotiate contracts and agreements related to biospecimen collection services.
• Manage client relationships and ensure high levels of satisfaction.
• Collaborate with internal teams to ensure the successful delivery of biospecimen collection projects.

Requirements:

• Years of Experience : 5+ years in business development, with experience in biospecimen collection or clinical research.
• Education : Bachelor’s degree in Business, Life Sciences, or a related field.
• Skills :
  • Strong negotiation and relationship-building skills.
  • Experience with biospecimen collection programs and the clinical research industry.
  • Ability to manage multiple business opportunities and stakeholders.