Research Associate III - Assay Transfer
This role is a key bridge between product development and manufacturing, leading complex laboratory work to support the transfer and scale-up of reagent products. The position focuses on process characterization, assay transfer, and continuous improvement within a regulated environment, using advanced wet lab and biological techniques to ensure products are manufacturable, robust, and aligned with quality standards.
Responsibilities
- Facilitate the transition of products from Development to Manufacturing as an integral member of the Assay Transfer team.
- Initiate, direct, and execute process characterizations, scientific research, and manufacturing process strategies to support new and existing reagent products.
- Investigate the feasibility of applying scientific principles and concepts to potential inventions, products, and problems to ensure manufacturability and improve processes, using Design for Six Sigma and Design for Quality and Manufacturability (DQM).
- Plan and execute laboratory research related to process characterization, scale-up activities, and improving process capability for reagent products.
- Maintain broad knowledge of state-of-the-art principles, theories, and experimental approaches relevant to biological assays and manufacturing processes.
- Prepare manufacturing documentation and complete transfer activities for new products, ensuring clarity, accuracy, and compliance with internal standards.
- Use professional scientific concepts to contribute to the development of product and process principles and achieve project objectives in creative and effective ways.
- Lead the design, execution, and troubleshooting of complex laboratory protocols and bench experiments with minimal supervision.
- Utilize deep analytical judgment as a subject matter expert to solve complex technical problems, optimize laboratory workflows, and identify opportunities for patents or publications.
- Maintain meticulous experimental records, analyze quantitative data, and generate comprehensive technical reports while championing Quality First Time standards.
- Partner actively across organizational boundaries, participate in cross-functional technical teams, and communicate experimental findings and recommendations clearly to stakeholders.
- Contribute creatively to project planning and strategy, helping to define experimental approaches and timelines for assay transfer and process improvement projects.
- Help implement laboratory improvements, including optimization of procedures, tools, and documentation practices to enhance efficiency and data quality.
- Train and mentor other team members in areas of expertise, including experimental techniques, data analysis methods, and best practices for documentation and quality.
- Search and review scientific literature to gain general and specific information that informs experimental design, troubleshooting, and process optimization.
Requirements
- Bachelor’s degree in a scientific discipline (such as biological science or related field).
- 4–6 years of post-college experience in a relevant scientific or technical role.
- Hands-on experience with wet lab and biological techniques, including routine and complex assay execution.
- Experience working in a regulated environment, ideally within product development and/or manufacturing operations.
- Demonstrated ability to design, execute, and troubleshoot complex laboratory protocols and bench experiments with minimal supervision.
- Strong analytical judgment and problem-solving skills for addressing complex technical challenges and optimizing workflows.
- Ability to perform process characterization and scale-up activities for reagent or assay-related products.
- Experience preparing clear and accurate manufacturing documents and technical reports.
- Proficiency in maintaining meticulous laboratory records and analyzing quantitative data.
- Capability to apply scientific principles and concepts to evaluate manufacturability and process improvements.
- Skill in searching and interpreting scientific literature to inform experimental design and problem-solving.
- Proficiency with word processing, spreadsheet, graphical, and presentation software applications.
- Effective communication skills for collaborating across cross-functional technical teams and presenting findings to stakeholders.
Additional Qualifications
- Diverse experience across different types of wet lab, assay, or biological science environments is a strong plus.
- Experience applying concepts from Design for Six Sigma and Design for Quality and Manufacturability (DQM) to product and process development.
- Experience in reagent product development and assay transfer activities is highly beneficial.
- Experience identifying patent or publication opportunities from technical work.
- Demonstrated ability to contribute creatively to project planning and laboratory improvements.
- Experience training and mentoring colleagues in laboratory techniques, data analysis, and documentation practices.
Work Environment
This is an onsite Research Associate III position within a laboratory and manufacturing support environment. The role involves extensive hands-on work in wet lab settings, including assay development, process characterization, and reagent product support. You will work closely with cross-functional teams in development and manufacturing, using standard laboratory equipment and analytical tools as well as common office software for documentation, data analysis, and presentations. The environment emphasizes high-quality documentation, adherence to regulated processes, and collaboration across organizational boundaries, with a strong focus on Quality First Time standards and continuous improvement.
Pay
The pay range for this position is $34.00 - $34.00 per hour.
Benefits
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental, and vision
- Critical Illness, Accident, and Hospital insurance
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short- and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation, or Sick Leave)
Schedule
This is a Contract, fully onsite position based in Oro Valley, AZ.