Locus Biosciences is seeking a highly motivated and experienced applicant to join our team as a full-time Associate Director of Analytical Development responsible for leading a team of analytical to develop common analytical methods for biologics to support subsequent clinical and/or commercial GMP manufacturing as well as reporting on human study data.
As a member of the leadership team, the Associate Director will be responsible for the strategic planning and growth of analytical development functions. Experience working in a GMP and CLIA lab with a strong record of accomplishment of performance is required.
- Change the future of medicine and address a serious and unmet patient need by developing a completely novel therapeutic modality
- Fasttrack your career by tackling large & meaningful projects
- Work with a team of exceptionally talented and hardworking individuals while striving to achieve a common mission
- We have 4 simple core values: Team First, Transparency, Hardwork, and Critical Thinking
- Stock options & bonus pool eligibility
- Health, dental, vision, life insurance, 401(k), and PTO
- L.E.A.D program certification/training for the selected candidate
- Free access to fitness center and classes
Responsibilities will include:
- Perform method development and validation employing phase-appropriate approaches at different stages of development (pre-clinical through Phase 3).
- Lead the development of UPLC methods (PEG, and PS80) for biologics
- Lead the development of other common analytical methods such as ELISA, qPCR, Endotoxin, host cell protein, potency, titer, and other cell-based assays.
- Perform, manage, train EM testing
- Establish quarterly EM reporting
- Support IND/BLA CMC analytical process document preparation Module 3.
- Direct analytical innovation projects, new technology evaluation/ implementation, as well as conference presentation and journal publication.
- Contribute to department and corporate strategic planning and objectives setting.
- Mentor team members and manage department budget.
- Provide technical support and represent analytical development functions in partner meetings.
- Author SOPs, protocols and technical reports and ensure adherence to high technical standards and compliance with applicable regulatory guidelines.
- Maintain accurate experimental records and results in laboratory notebook and/or datasheet.
- Develop phase-appropriate quality control strategy for drug substance and drug product
- Manage product stability study programs
- Demonstrate extensive knowledge in state-of-the-art analytical technologies
- Demonstrate familiarity with QBD approach to provide analytical support to drug substance and drug product manufacture
- Author analytical development and validation reports and analytical sections in IND and NDA filings
- Closely coordinate with QA and Regulatory, as well as other CMC functions, Clinical and Toxicology regarding safety-related questions on APIs, components of APIs and formulations and materials used in processing
- Perform other CMC related duties as required
- Serve as the CMC representative on cross-functional project teams
- Manage internal analytical development laboratory and analytical personnel to support pipeline programs
- A preferred candidate will also possess significant CLIA testing experience in addition to the above requirements.
- Knowledge on AAV or other viral vector analysis and characterization a plus.
- Able to analyze complex analytical problems, develop strategic initiatives and execute technical programs, and make recommendations to executive management.
- Effective organizational and staff management skills
- Significant people management experience in addition to good leadership skills
About Locus Biosciences
Locus Biosciences is a clinical-stage biotechnology company developing precision antibacterial products to address critical unmet medical needs in treating bacterial infections and microbiome indications. The Locus platform engineers bacterial viruses called bacteriophages to specifically kill target pathogens while leaving non-target bacteria (i.e., the rest of the patient’s microbiome) unharmed and to deliver biotherapeutic payloads to the body sites where they are needed. Locus’s lead program is an engineered bacteriophage product targeting Escherichia coli bacteria in the urinary tract, currently being tested in an active Phase 2/3 clinical trial. Locus has collaborations with BARDA and CARB-X to develop engineered bacteriophage products targeting E. coli infections and Klebsiella pneumoniae infections, respectively. For more information about Locus visit https://www.locus-bio.com/
Job Type: Full-time
Job Location: Research Triangle Park, North Carolina
For immediate consideration, please email your resume or CV to: firstname.lastname@example.org
Direct applicants only. No agencies please.