Associate Director, Process Development

The Role:

ElevateBio is looking for an Associate Director to provide leadership and oversee all RNA process development activities within Basecamp®. The RNA process development team is responsible for the development, optimization, and characterization of RNA production processes, tech transfer and scale up activities and for generating high quality RNA encapsulated in LNPs for research purposes. We are looking for an enthusiastic leader to come and set up a new RNA lab, manage a team of scientists and work on collaboration with internal and external stakeholders to ensure project advancement and best in class execution. We seek candidates with prior mRNA process development experience and proven ability to lead scientific teams.

Here’s What You’ll Do:

• Establish a new lab for research-grade RNA DS and DP production at the Waltham facility within Basecamp®
• Lead the RNA process development team and provide oversight of all team activities
• Manage internal and external communications on behalf of the team, ensure alignment of the team’s activity with company priorities
• Manage experimental timelines to meet corporate goals
• Responsible for mentoring a team of scientists in the laboratory and supporting the design, execution and interpretation of experimental studies
• Lead technology transfer activities by performing risk assessments, reviewing development reports, authoring and reviewing master batch records for GMP manufacturing, and providing technical support.
• Manage a core function within the team to supply high quality mRNA for research applications
• Author, review and/or approve Standard Operating Procedures (SOPs), batch Records, risk assessments and any required documents to run the lab effectively.
• Author, review and/or approve Technical Protocols and Reports
• Assist in the identification, evaluation and/or implementation analytical techniques for mRNA characterization and Process understanding and control
• Support late-stage process characterization activities and GMP manufacturing campaigns, as needed
• Provide subject matter expertise and attend cross-functional team meetings as needed
• Promote a safe work environment in the laboratories
• Must be willing to have flexible schedule based on experimental and company needs (including possible travel)

Requirements:

• MSc with 10+ years or PhD with 8+ years of relevant industrial experience. Degree emphasis in Biochemistry, Chemical Engineering, Molecular Biology, Bioengineering, or related field.
• Previous experience managing/mentoring scientists in a laboratory setting is required
• Technical understanding and experience in biopharmaceutical process manufacturing operations in an industrial cGMP environment
• Understanding of nucleic acid chemistry, enzymatic and chemical reactions, PCR, plasmid processing, and standard analytical techniques for RNA.
• In-depth understanding of RNA DSP operations of biologics such as chromatography and ultrafiltration is required.
• Hands on experience with in vitro transcription and mRNA purification technologies
• Experience with Technology Transfer of manufacturing processes
• Proficient with ÄKTA systems and UNICORN control software.
• Experience with high-throughput process development techniques and statistical design of experiments (DoE) strongly preferred.
• Understanding of requirements for development of biologics including requirements for product comparability.
• Experience in working with external partners, clients and vendors is a plus
• Track record of completing deliverables within specified timelines.
• Knowledge of GMP/ICH/FDA regulations strongly preferred.
• Independently motivated, detail oriented and good problem-solving ability.
• Excellent organizational skills and ability to multi-task in an extremely fast-paced environment with changing priorities.
• Excellent communication, technical writing and presentation skills and the flexibility to work on multiple projects as needed is a must
• Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view