Development Scientist

Locus Biosciences is seeking a highly motivated and experienced applicant to join our team as a full-time Development Scientist responsible for developing biologics purification processes and formulations, serving as a subject matter expert and lead scientist in partner relationships, and leading early phase clinical trial material manufacturing in an aseptic processing environment. This position is well suited for those that have demonstrated manufacturing and laboratory experience in addition to exceptional communication skills, technical aptitude and problem-solving skills. Experience working in regulated, pharmaceutical/biotechnology R&D (GDP, GLP) and/or manufacturing environments (cGMP) is required.

Why Locus?

• Change the future of medicine and address a serious and unmet patient need by developing a completely novel therapeutic modality using CRISPR/Cas technology
• Fast-track your career by tackling large & meaningful projects
• Work with a team of exceptionally talented and hardworking individuals while striving to achieve a common mission
• Bonus pool eligibility
• Health, dental, vision, life insurance, 401(k), and PTO
• Free access to fitness center and exercise classes

Responsibilities will include:

• Designing and executing formulation development activities to support oral, IV, and nebulized drug delivery.
• Designing and executing bench-scale process and associated scale-up 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
• Serving as project lead and subject matter expert for partnered assets responsible for effectively communicating development strategies and progress to internal and external stakeholders via reports and presentations.
• Supporting tech transfer of new products and processes to ensure smooth transition from R&D to process development to GMP manufacturing through evaluation of key product parameters.
• Forming strong relationships with all stakeholders, including technicians, associates, scientists, and the project managers to enable successful tech transfer
• Preparation of batch records, protocols, SOPs, deviations, technical reports, presentations, and other CMC documents to support drug development, including development reports, INDs, BLAs, and other applications
• 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 team effort in the effective and timely completion of root cause investigations and CAPAs
• Supporting a high-performance teamwork environment through collaboration, transparent communication, and a problem-solving mindset.
• Managing one or more direct reports in a matrixed management structure

Education:

• A PhD degree in chemistry, chemical engineering, biomolecular engineering or related field.

Experience and Expertise:

• Minimum of 2 years viral vector development or manufacturing experience
• Minimum of 2 years of downstream method development
• Knowledge of SOPs, cGMPs, and GLPs and the know how to work and manage within a regulatory environment
• Ability to demonstrate strategic and analytical thinking, problem solving, and rapid decision making skills.
• Ability to work in a fast-paced team environment with fluctuating priorities and collaborate effectively with others
• Excellent organizational and time management skills with ability to set individual and team priorities and effectively communicate timelines and opportunities to organize work to maximize efficiencies.
• High degree of flexibility, adaptability, and independence; able to work as needed to meet tight deadlines with a strong attention to detail
• Demonstrated capability in implementing challenging goals, objectives, and processes in a complex environment.
• Experience with tech transfer and scale up of biologics production
• Strong experimental design and statistical analysis skills with experience analyzing development and production scale data
• Ability to communicate with and understand requirements from experts across diverse disciplines including microbiology and data science
• Detail-oriented mindset that can identify and test the optimization parameter space
• Ability to structure, implement and maintain study plans in the face of ambiguity
• Willingness to develop solutions to difficult objectives independently and consistently
• Excellent verbal and written communication skills including proficiency in technical writing, and demonstrated ability to translate technical issues into business impact assessments.
• Experience working in cross-functional organization with ability to multitask, prioritize and be an effective and influential decision maker

Preferred Qualifications:

• Experience in drug formulation development
• Experience working in a cGMP environment
• Expertise in bioinformatics with a working understanding of genomic analysis solutions
• Experience in coding languages (i.e., python, R, Julia, bash etc.)
• Expertise in setting up cloud-based solutions to host and execute NGS analysis pipelines.
• Experience developing automated protocols using liquid handlers, robotic workcells, and other scientific instrumentation.
• Experience in genotyping and variant calling.
• Experience with cell culture

• Experience in a start-up environment and pre-clinical through commercial GMP Manufacturing
• Understanding of industry expectations with respect to phase appropriate requirements while advancing products from clinical to commercial state

• Previous management experience

About Locus Biosciences

Locus Biosciences is a clinical-stage biotechnology company developing CRISPR-enhanced precision antibacterial products (crPhage^™) to address critical unmet medical needs in bacterial infection and microbiome indications. The Locus platform combines CRISPR-Cas3, which permanently degrades target DNA within a bacterial cell, with bacterial viruses called bacteriophages to specifically kill target pathogens while leaving non-target bacteria (i.e., the rest of the patient’s microbiome) unharmed. Locus’ lead asset is in Phase II clinical trials with a crPhage product targeting Escherichia coli bacteria in the urinary tract. Locus has strategic collaborations with BARDA, and CARB-X to develop crPhage products targeting E. coli urinary tract 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

Job Location: Research Triangle Park, North Carolina

Direct applicants only. No agencies please.