Title: Senior mRNA Scientist
Location: Durham, NC
Duration: 6-month contract-to-hire
As a member of GMP leadership team, the Director will report to the Senior GMP Director and be primarily responsible for guiding the development of mRNA and other select protein and adjuvant products. This includes the development, tech transfer, and GMP execution of production processes for mRNA vaccine components and products for use in protecting or treating those with infectious diseases such as HIV, Influenza and SARS-CoV-2. This position will also participate in, and sometimes lead, alliance management related to mRNA products where the interactions are targeted to acquiring mRNA or lipid nanoparticle (LNP) technology or collaborating on vaccine development. For other GMP products, this position will steer product integration and be involved in preclinical toxicity studies, bioprocess development and GMP production, including lab scale process development; scale up and tech transfer of the process into the GMP group, and execution of the process under GMP compliant conditions.
40% Technical & Product Integration
· Works closely with faculty, leadership, GMP leadership and program team to direct Upstream and/or Downstream aspects of lab scale process development and GMP production for mRNA products including:
- Works with leadership and GMP leadership to evaluate pre-clinical data for each mRNA product under consideration for development.
- Works with Process Development team to develop and execute upstream techniques such as in vitro transcription scaling and related method; develop and execute downstream techniques including scale-up of mRNA and LNP production and encapsulation; and ensure mRNA purity and intact status as well as removal of double-stranded DNA. Participates in review of analytical data and troubleshooting technical issues.
- Works with Analytics Development team to develop product specifications and stability protocols. Participates in review of analytical data and troubleshooting technical issues.
- Works with GMP production team to process scale up, tech transfer, and execute the process of mRNA production, LNP encapsulation and mRNA/LNP fill-finish under cGMP conditions.
- Works with the Quality Assurance team to ensure compliance with Current Good Manufacturing Practice for Phase 1 investigational drugs.
- Leads in on-boarding new mRNA and LNP technologies.
- Develops drug product fill/finish vial and label requirements.
20% Alliance Management & Tech Transfer
- Identifies and develops collaborations with external organizations such as NIH NIAID, Division of AIDS and Vaccine Research Center, Walter Reed Army Institute of Research, Gates Foundation, IAVI and other partners to provide guidance and support for mRNA activities as part of the DHVI Strategic Alliance initiative.
- Partners with GMP Senior Director and Team Leads to scout and evaluate CDMOs and CROs for external manufacturing and testing support. Reviews associated contracts and scopes of work.
- Works closely with Director of Intellectual Property, Agreements Manager and Office of Technology Commercialization, providing advice regarding patents, licensing, procurement and alliance management as relevant to mRNA.
20% Strategy & Planning
- Participates in and sometimes leads strategic planning processes for mRNA technology acquisition and use, including facilitating the development of strategic priorities and annual organizational goals that optimize resources and increase operational efficiency by decreasing costs and mRNA product development timelines.
- Monitors mRNA product progress and pitfalls and routinely advises leadership on tactical and strategic directions for restorative actions as needed.
10% – Toxicity Studies
- Plans and manages preclinical toxicity studies, reviews study reports and presents findings to GMP and Department leadership.
10% Data & Regulatory Review and Reporting
- Facilitates team data review and discussion at group meetings and larger team settings. Provides insight as an external reviewer, and provides perspective to de-risk programs.
- Leads review of technical development reports; writes and reviews protocols for tech transfer and SOPs for GMP production as relevant, and either presents data to project teams and larger settings or identifies presenters for this purpose.
- Partners with GMP Senior Director to evaluate data packages, requests for proposal, scopes of work, and slide decks and provides scientific, technical and regulatory guidance. Also prepares, reviews and edits regulatory documents.
- Bachelor's degree in a science, engineering, or related field. An advanced degree (Master's, PhD) is preferred.
- 4-6 years relevant experience in the biopharmaceutical industry or equivalent.
- Strong knowledge of cGMP compliance and extensive experience in development of mRNA products and techniques for GMP manufacturing of vaccines.
- Demonstrates innovation and knowledge of all aspects of mRNA and LNP product development and GMP manufacturing.
- Must work independently to develop specific processes or methods in line with strategic program goals.
- Demonstrated advanced ability in solving complex analytical problems in alignment with strategic project plans.
- Experience with structuring and negotiation business development, contracts and licensing transactions within a pharmaceutical/biotech company or related business.
- A good understanding of finance required, including previous experience managing complex budgets.
- Superior interpersonal and written communication skills for bridging GMP staff with scientists and leadership, as well as for bridging academic and business partners for various partnership activities.
- Sound business judgement, with the ability to synthesize and summarize a complex set of facts and set opportunities within the broader strategic context.
Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.