Locus Biosciences has an immediate need for a highly motivated and experienced applicant to join our team as a full-time Development Technologist or Development Specialist responsible for developing biologics purification processes and formulations, as well as supporting early phase clinical trial material manufacturing in an aseptic environment. This position is well suited for those that have demonstrated laboratory 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.
SHIFT: Full-Time Days, with occasional evening and weekend work
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
Performing laboratory assays
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, 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?
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 in pharmaceutical, biotechnology, and/or sterile production environment
Experience in biologics (upstream, downstream, aseptic fill/finish) with working knowledge of FDA regulations and GMP systems
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
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 focused on the development of a next-generation CRISPR-Cas platform for precision antimicrobials. This platform directs the powerful CRISPR-Cas3 nuclease to target and kill bacterial cells by irreversibly destroying their DNA. Using the platform, Locus has created a new class of antimicrobials that eliminate pathogenic bacteria, including antibiotic-resistant strains, while leaving non-target species unharmed. Locus is currently developing products for critical disease areas, including deadly bacterial infections and large-market microbiome applications. Locus announced an $818 mln partnership with Johnson & Johnson in 2019. The company’s core values are hard work, transparency, and critical thinking, and candidates and employees are rigorously evaluated on these metrics.
Job Type: Contract with potential for full time
Job Location: Research Triangle Park, North Carolina
For immediate consideration, please email your resume or CV, with optional cover letter, to: email@example.com.?