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Job: Development Specialist, Locus Biosciences, Morrisville, NC

General Information

Job title:
Development Specialist
Job location:
Morrisville, NC  27560 United States
Requisition code:
Date posted:
Job category:
Manufacturing and Production
Employment type:
Full time

Job Description

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?

Preferred Qualifications:

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:

Job Requirements

(see job description above)
(Job number: 3883313)
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