Process Sciences Engineer

Primary Responsibilities:

• Work on lipid nanoparticle (“LNP”) manufacturing
• Focus on scale-up and optimization of lipid nanoparticles, supporting delivery of base editors
• Contribute to the development and scaling of a manufacturing process in order to bring in-vivo base editing to patients
• Work on process manufacturing, optimization and nanoparticle formation; large biomolecule production; manage aseptic unit operations for sterile drug product manufacture; and process and analyze frozen and lyophilized formulations for clinical-stage drug product
• Design and execute experiments to optimize nanoparticle formulation and manufacturing processes deployed, including in the area of tangential-flow filtration and mixing
• Execute laboratory-based experiments, supporting a robust reproducible process, underlying key manufacture of clinical trial materials used at Beam
• Design and execute laboratory experiments used to evaluate and optimize stability of drug product
• Support development of automated processes for LNP manufacturing across mixing geometries, scales, components and payloads
• Engage in technology transfer exercises, both within the company and externally, as a subject-matter expert in the area of LNP drug product manufacturing
• Contribute to related process development initiatives involving change controls, process deviations, and write material focused on promoting quality engineering excellence
• Supports data aggregation and analysis of corporate LNP manufacturing having internal and external applications in order to effectively define process characterization, optimization, and control activities, used and deployed
• Contribute to generating high-quality documentation for scientific-focused Standard Operating Procedures, applied at Beam Therapeutics
• Contribute to generating high-quality scientific content in support of regulatory filings, made and advanced by Beam

Qualifications (one way to qualify):

• Bachelor’s degree or foreign equivalent in bioengineering, biomedical engineering, chemistry, chemical engineering, pharmaceutical sciences, or related field; and
• Also requires possession of five years of progressive, post-baccalaureate experience in all of the following areas:

• Applying Current Good Manufacturing Practices regarding large biomolecule production and aseptic unit operations for sterile drug product manufacture; and
• Engaging in LNP process development or manufacturing; and
• Manufacturing frozen or lyophilized formulations in support of clinical-stage drug product.

Alternative Qualifications:

• Master’s degree or foreign equivalent in bioengineering, biomedical engineering, chemistry, chemical engineering, pharmaceutical sciences, or related field; and

• Also requires possession of two years of experience in all the following areas:
• Applying Current Good Manufacturing Practices regarding large biomolecule production and aseptic unit operations for sterile drug product manufacture; and
• Engaging in LNP process development or manufacturing; and
• Manufacturing frozen or lyophilized formulations in support of clinical-stage drug product.

Other Information:

• Permanent, full-time, immediately available, job opportunity
• Does not require any travel (as role is laboratory-based, in-house)
• Primary worksite long-term: 238 Main Street, 9th Floor, Cambridge, MA 02142
• Must therefore live in the City of Cambridge, MA, or within a reasonable, daily commuting distance thereof, e.g., areas contemplated can include the City of Boston, the larger Greater Boston region, or Massachusetts’ MetroWest, North or South Shore communities
• Telecommuting (exclusively working remotely from home) is not available for this lab-based team and role, this due to the laboratory-based nature of the work and role; position again works full-time from company headquarters in Cambridge, MA, requiring the person to live locally in Greater Boston
• Position is not a supervisory capacity; it does not have subordinate, direct reports beneath it, as it does not manage other company personnel
• Position is a hands-on, individual contributor, responsible chiefly for LNP manufacturing, scale-up and optimization, and is involved with delivery of base editors
• Role does not manage other personnel and is not supervisory in nature

Applicants should send resumes directly to the employer.  May simply apply below.  We look forward to hearing from you.  Come join the Beam Team!