Locus Biosciences is seeking a highly motivated and entrepreneurial applicant to join our company in a full-time, entry-level position that will rotate between our Chemistry, Manufacturing and Controls (CMC) and Research & Development (R&D) departments during this 2 year rotational program. This position is well suited for those looking for an entry-level position that is excited to learn all aspects of biotechnology drug development from early-stage research through drug product manufacturing. Candidates will be expected to accomplish defined work, as well as assist in approaching and solving complex scientific problems. Candidates should have demonstrated laboratory or manufacturing experience, with solid communication, technical aptitude, and problem-solving skills. Experience working in regulated, pharmaceutical/biotechnology R&D (GDP, GLP) and/or manufacturing environments (cGMP) is strongly preferred, but not required.

Why Locus?

• Change the future of medicine and address a serious and unmet patient need by developing completely novel therapeutic modalities.
• Fast-track your career by tackling large & meaningful projects and learning a breadth of techniques and skillsets in the wet lab and manufacturing suites
• Work with a team of exceptionally talented and hardworking individuals while striving to achieve a common mission
• Partner with the most highly respected pharmaceutical companies in the world
• Bonus pool eligibility
• Health, dental, vision, life insurance, 401(k), and PTO
• Free access to fitness center and classes

Responsibilities will include:

• Designing and/or executing formulation development activities
• Designing and/or executing bench-scale process development activities, including set-up and operation of development-scale bioreactors, filter trains, tangential flow filtration (TFF) equipment, and chromatography equipment
• Development of analytical strategies to inform formulation and process development activities
• Design and deploy automated workflows for molecular biology and microbiology assays, including liquid handling automation, next-generation sequencing (NGS) library preparation, and high-throughput screening of phage activity to accelerate research timelines and improve experimental reproducibility.
• Support the development of data infrastructure and bioinformatics pipeline for R&D and CMC operations, including DNA sequence analysis, sequence assembly, and comparative genomic analysis.
• Molecular biology and synthetic biology– Cloning, NGS library preparation, characterization of novel genetic engineering tools, and generation and analysis of novel engineered phage clones
• Microbiology – Culturing both aerobic and obligate anaerobic organisms. Utilizing a range of bacterial strains to produce and characterize activity of phage
• Independent management, planning, and execution of multiple projects, including reviewing, interpreting, and recording results.
• Supporting tech transfer of new products and processes to ensure smooth transition from R&D to process development to GMP manufacturing
• Forming strong relationships with all stakeholders, including technicians, associates, project and program managers, and scientists to enable successful tech transfer
• Supporting Scientists in all aspects of pharmaceutical development
• Assisting in the preparation of batch records, protocols, SOPs, deviations, technical reports, presentations, and other CMC documents to support drug development, including INDs, BLAs, and other applications
• Gaining aseptic gowning and fill qualification
• Performing material handling and staging
• Practicing real-time documentation (such as batch records) during production run and maintain accurate records/logs according to GDP
• Supporting Qualification and Validation activities
• Identifying, communicating, and troubleshooting process issues
• Supporting team effort in the effective and timely completion of root cause investigations and CAPA
• Supporting a high-performance teamwork environment

Rotations may include a combination of any of the following functions:

• Research and Development including but not limited to phage discovery, phage engineering, and strain engineering.
• High Throughput Development (Automation)
• Bioinformatics
• Material Sciences & Technology
• cGMP Manufacturing
• Analytical Development
• Quality Control
• Clinical Lab
• Quality Assurance
• Project Management Office
• Clinical Operations

Education:

• Technical certificate or degree (e.g. BTEC Biomanufacturing), or graduation from an accredited college/university with a Bachelor’s to a Master’s degree in Biology, Chemistry, Biochemistry, Chemical Engineering, Biophysics, Pharmaceutical Technology or related field, with some lab experience (required)

Experience and Expertise:

• Familiarity with general laboratory techniques such as pipetting, serial dilutions, aseptic technique and proper decontamination procedures
• Experience in research, pharmaceutical, biotechnology, and/or sterile production environment
• Experience executing SOPs and documenting work
• Strong mechanical aptitude
• Excellent oral and written communication skills
• Technical writing ability
• Thrives in a fast-paced, entrepreneurial and collaborative environment. Openly shares knowledge/information needed to accomplish a task or solve a problem

Preferred Qualifications:

• At least two years’ experience between academic or industry research
• Experience in biologics (upstream, downstream, aseptic fill/finish) with working knowledge of FDA regulations and GMP systems
• Experience with DNA sequence analysis, including homology searching, sequence assembly and primer design
• Ability to assist in the design of experiments and interpretation of results
• Motivation to learn new processes that contribute to the company's overall desire to get products into the clinic
• Technical proficiency with designing and executing standard molecular biology experiments (PCR, transformation, Gibson cloning)
• Experience with microbiology skills like growth curves, anaerobic microbiology, streaking and banking strains
• The level of the position will be based on the successful candidate’s qualifications.

About Locus Biosciences

Locus Biosciences is a clinical-stage biotechnology company developing precision antibacterial products to address critical unmet medical needs in treating bacterial infections and microbiome indications. The Locus platform engineers bacterial viruses called bacteriophages to specifically kill target pathogens while leaving non-target bacteria (i.e., the rest of the patient’s microbiome) unharmed and to deliver biotherapeutic payloads to the body sites where they are needed. Locus’s lead program is an engineered bacteriophage product targeting Escherichia coli bacteria in the urinary tract, currently being tested in an active Phase 2/3 clinical trial. Locus has collaborations with BARDA and CARB-X to develop engineered bacteriophage products targeting E. coli infections and Klebsiella pneumoniae infections, respectively. For more information about Locus visit https://www.locus-bio.com/

SHIFT: Full-Time Days, with occasional evening and weekend work

Job Type: Full-time, onsite

Job Location: Research Triangle Park, North Carolina

Direct applicants only. No agencies please.