ABOUT STRM.BIO

STRM.BIO (“storm bio”) is a pre-clinical, VC-backed biotechnology company that is leveraging extracellular vesicles (EVs) to deliver gene therapies in vivo. We believe in a culture where people come first and that personal accountability is key to a healthy organization. We believe that there is both elegance and efficiency in simplicity, and we let this approach drive both our science and our strategy.

STRM.BIO is located in Cambridge, MA, where we are driving research in our internal laboratory space while simultaneously leveraging the existing laboratory infrastructure and expertise of our scientific collaborators, contract development and manufacturing organizations (CDMOs), and advisors to focus on what matters--our research.

We are assembling a team of leaders who share our company values, who believe in the promise of EVs to bring transformative therapies to patients, and who will actively contribute to a culture of continuous learning, innovative discovery, and unyielding commitment to high quality science.

THE TECHNOLOGY

STRM.BIO is creating a proprietary EV platform to deliver gene therapies in vivo and establish a new class of therapeutics. EVs are natural carriers of nucleic acids and proteins and hold tremendous promise as direct cell messengers for gene therapies due to their innate targeting, tunable loading, and ability to repeat dose. At STRM, we are aiming to create new therapies and uniquely enable effective targeting of existing ones to democratize gene therapy. We are just beginning to explore the potential impact of our platform and are looking to recruit team members who can help us bring this larger vision to light.

THE PERSON AND ROLE

The Director of Analytical Development position is a full-time position that requires both strategic leadership and hands-on time in the lab, designing and conducting experiments. You will be leading and building STRM’s analytical development for the characterization of drug substances and drug product, developing bioassays supporting potency evaluation, and establishing appropriate stability activities, all in partnership with process development and regulatory teams.

To be successful in this role, you should be a self-starter, always up or a challenge and find the unique demands of the fast-paced startup environment motivating. You will need to be adept at managing both internal projects and external collaborations and be able to do both while espousing the people-first, simplicity-oriented values we hold as core to STRM culture.

More experienced candidates who enjoy benchwork are encouraged to apply.

KEY RESPONSIBILITIES

• Lead and build STRM’s analytical development for the characterization of EV drug substance and loaded EV drug product
• Develop phase-appropriate and risk-based analytical bioassay and potency testing strategies to support development projects related to preclinical and clinical studies
• Develop stable formulations of, and conduct stability studies for, EV drug substances and loaded EV drug products
• Independently develop, execute, and document analytical method development and qualification in support of process development, product release and stability, and product characterization of EV drug substance and loaded EV drug products
• Contribute to authoring, reviewing, and approving regulatory briefing documents, and participating in scientific advice preparations and meetings
• Act as a SME for analytical development and be responsible for knowledge/technology transfer of in-process and product characterization methods to STRM partners
• Author and review SOPs, technical reports, and supporting procedures for analytical development
• Work with external (CDMO and CRO) laboratories to assure robust method development, transfer, and execution in GMP and GLP settings
• Author method development and qualification reports and test methods. Evaluate suitability of new methods and oversee method qualification and validation as needed
• Hire and mentor staff and champion inclusive culture

QUALIFICATIONS & EXPERIENCE

Required

• PhD in Biological Sciences with over 8 years of experience or MSc in Biological Sciences with over 12 years of experience in the development of bioassays
• Experience developing and optimizing cell-based assays with demonstrated breadth of understanding around factors influencing their performance
• Experience with assay development for nanoparticle characterization (size, concentration, purity)
• Strong technical background as demonstrated by supporting the development of multiple therapeutic candidates
• Understanding of techniques for single cell analysis, cell phenotyping methods, and experience in cell or gene therapy
• Advanced hands-on experience with various common analytical techniques including ELISA, qPCR, and flow cytometry, and with nanoparticle analytical equipment utilizing NTA, DLS, etc.
• Scientific knowledge in the characterization and transfer of pharmaceutical products.
• Demonstrated understanding developing analytical methods in compliance with ICH
• In-depth understanding of regulatory guidelines and experience with CMC regulatory filings. Experience in technical oversight of analytical development would be a plus
• Experience preparing technical documents for internal distribution or inclusion in regulatory filings
• Excellent communication, technical writing, and presentation skills
• Exceptional teamwork and interpersonal skills with the ability to motivate others, influence, and negotiate difficult situations
• Demonstrated experience building and leading exceptional teams
• Excellent interpersonal and organizational skills, strong attention to detail, and demonstrated ability to collaborate effectively on cross-functional teams and within a dynamic environment
• Excellent analytical and problem-solving skills, with a strong ability to troubleshoot critical issues or problems and determine both causes and possible solutions
• Ability to balance/prioritize research efforts across multiple programs, meet deadlines, and shift plans in service of a rapidly changing startup environment
• Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results
  

Preferred

• Knowledge and experience in developing and qualifying analytical methods for biologics or gene therapy products are highly preferred
• Understanding of gene therapy vector characteristics and critical attributes to direct bioprocess development and product/process control strategies
• Experience with bioassay development and defining potency testing strategy for biotherapeutics
• Experience in an industrial setting or GxP environment
• Experience with in vivo testing, particularly for the evaluation of biotherapeutics
• Experience establishing and managing interactions with CROs and CDMOs
  

KEY POSITION DETAILS

• Full-time Position
• Salary and benefits consistent with the competitive market of Boston/Cambridge and commensurate with experience
• In-person benchwork in Boston/Cambridge area and/or at partner headquarters location(s)