CMC Data Compilation & Partner Transfer Support

CMC Data Compilation & Partner Transfer Support Contractor This contract role focuses on compiling, organizing, and securely transferring CMC-related documents and raw development data to an external partner. You will prepare comprehensive analytical development and process development data packages that enable efficient, traceable, and compliant technology transfer. The position requires significant onsite presence to access instruments and raw data systems and to collaborate closely with analytical development, process development, quality, and legal teams, while working primarily at a desk within a highly innovative oncology-focused biotech environment. Responsibilities Compile, organize, and prepare CMC documentation and raw development data for transfer to an external partner, ensuring clarity, traceability, and usability. Support data and document preparation for Analytical Development, including raw analytical data, method development reports, and qualification reports. Support data and document preparation for Process Development, including process development data, run summaries, and supporting documentation. Identify, retrieve, and organize raw data from multiple sources such as instruments, electronic lab notebooks, and data management systems. Ensure data packages are interpretable and logically structured for external review, including consistent file naming, indexing, and use of metadata where appropriate. Identify data gaps, inconsistencies, or ambiguities and proactively collaborate with subject matter experts to resolve issues or clearly document limitations. Review documents and datasets for sensitive or confidential information and perform careful redaction in line with internal guidance and partner agreements. Navigate and extract relevant records from systems such as Benchling, electronic lab notebooks, and LIMS platforms, including linking raw data to reports and summaries. Track information efficiently across programs and datasets, following data trails back to source documentation to maintain strong data traceability. Work closely with Analytical Development, Process Development, CMC, Quality, and Legal team members to clarify data context, fill information gaps, and resolve questions. Maintain version control and documentation status tracking to support timely, accurate, and auditable partner data transfers. Use project tracking tools such as Smartsheet and Excel to monitor progress, maintain trackers, indexes, and data inventories, and report on status. Coordinate and communicate frequently in person with cross-functional stakeholders to align on priorities, timelines, and data requirements. Manage routine and repetitive data compilation tasks with consistency and accuracy, ensuring high-quality outputs for partner-facing data packages. Apply an understanding of flow files, plate reader outputs, and chromatograms to correctly interpret, organize, and link analytical data. Handle confidential and partner-sensitive data responsibly, recognizing and respecting data-sharing boundaries throughout the transfer process. Essential Skills Prior experience supporting CMC, Analytical Development, Process Development, or technology transfer activities in a biopharmaceutical, cell therapy, or gene therapy environment. Hands-on experience with Benchling, including navigating and extracting records from Benchling-based workflows (required). Experience working with LIMS platforms to locate, retrieve, and organize scientific data (required). Familiarity with querying Benchling-backed relational datasets, such as PostgreSQL, to support data traceability, reconciliation, or verification activities. Demonstrated ability to locate, interpret, and organize raw data from diverse sources, including instruments, electronic lab notebooks, and data management systems. Strong attention to detail with a focus on data integrity, traceability, and document control. Experience handling confidential information and performing thoughtful, compliant redactions prior to external data sharing. Ability and willingness to work onsite regularly to interact with laboratory equipment, raw data systems, and instrument outputs. Comfort working independently with minimal oversight while coordinating effectively with cross-functional teams. Strong organizational and project-tracking skills, including use of trackers, indexes, and data inventories to manage complex data sets and activities. Accountability for meeting deadlines and delivering high-quality work on time in the context of large and complex projects. High level of comfort with routine and repetitive tasks, with a strong drive to complete to-do lists and close out work efficiently. Effective interpersonal and communication skills, with the ability to talk to people across departments and collaborate constructively. Additional Skills & Qualifications Familiarity with regulated environments such as GLP, GMP, or broader GxP-adjacent work is preferred but not required. Prior experience preparing partner-facing data packages, data rooms, or technology transfer documentation is highly beneficial. Background in analytical assays, process development, or manufacturing sciences is an advantage. Experience with electronic lab notebooks (ELNs), including navigation, data extraction, and linking ELN entries to raw data and reports. Understanding of flow cytometry data files, plate reader outputs, and chromatograms to support accurate data interpretation and organization. Experience using Smartsheet and Excel for project tracking, data organization, and status reporting. Experience managing projects or workstreams, including planning, prioritization, and follow-through on complex, multi-step tasks. Demonstrated adaptability and flexibility when priorities shift, with the ability to remain effective and composed under changing demands. Curiosity and initiative to follow data trails, ask clarifying questions, and continuously improve data structures and workflows. Comfort working with development data in a non-GMP context, with GMP experience considered a plus but not required. Openness to learning new systems, tools, and processes in a fast-moving biotech environment. Work Environment This is an onsite, desk-based role embedded within a dynamic biotechnology setting focused on innovative immunotherapy for cancer. You will work primarily at a computer, accessing development data and raw instrument outputs through systems such as Benchling, electronic lab notebooks, LIMS platforms, Smartsheet, and Excel. Although you will not perform laboratory experiments, you will spend significant time onsite to interact with laboratory equipment, raw data systems, and cross-functional teams in Analytical Development, Process Development, CMC, Quality, and Legal. Job Type & Location This is a Contract position based out of Louisville, CO. Pay and Benefits The pay range for this position is $43.27 - $52.88/hr. 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 & vision
• Critical Illness, Accident, and Hospital
• 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) Workplace Type This is a fully onsite position in Louisville,CO.

Application Deadline This position is anticipated to close on May 21, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.