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 in the first year.
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.
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 molecular biology and microbiology laboratory assays
- 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
Education, Experience and Expertise:
- Technical certificate or degree (e.g. BTEC Bio-manufacturing), 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)
- 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 strain
Apply here https://www.indeed.com/viewjob?jk=a14729d4c7fd3291&from=shareddesktop
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