City
Rtp

State
NC

Job Type
Full-Time Regular

Job Description

Top 3 Skills
1. Background in Chemistry or Biology - Specialist level requires PhD, Developer requires Master's; ability to design and/or develop formulary 2. Passion for biotechnology, specifically small molecule antibiotics - WILLING TO WORK UP TO 60 HOURS/week - That is in all caps bc Locus isn't for everyone 3. Passion for problem solving, science and high performance

BCTG
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 molecular biology and microbiology 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, 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

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
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