Locus Biosciences is seeking a dynamic Manager of Technical Operations responsible for providing key leadership, direction, organization, management, monitoring and cGMP compliance of the roles, activities of all assigned manufacturing staff to ensure the successful, cost effective, timely and safe processing of clinical-stage GMP materials. A successful candidate would be responsible for the planning, scheduling, and all production activities at the manufacturing site, including all upstream, downstream, and filling, and warehousing activities.
The successful candidate will work with the executive team members and operations staff to provide focus and direction for performance within a matrix environment and will work across multiple teams to achieve objectives.
Responsibilities will include:
Manages and directs the employees and functions of manufacturing areas to include the preparation of equipment and components and production and final batch review for clinical trial materials.
Manages and directs the employees and functions of technical operations and other areas to include capital expenditure projects and new product introductions.
Manages all operational aspects of the area including productivity, cost, planning and training, and daily activities.
Ensures compliance with all applicable SOPs and regulations, cGMPs, and safety guidelines in collaboration with site Quality.
Define and ensure all personnel receive necessary and appropriate training for their job function and manage development of staff.
Responsible for management of deviations and risk management associated with the manufacturing process or it’s components.
Effectively manages employee relations including hiring, discipline, rewards and recognition, and effective equity management.
Communication of the manufacturing and EM schedules.
Participates and represents Company in Regulatory and third-party audits and inquiries.
Develop and achieve annual budget for Technical Operations and accountable for identifying, managing, and communicating budget and overruns.
Develop capital expenditure justifications, return on investment and recommendations.
Lead Operational Excellence initiatives to improve operational efficiencies within areas of responsibility.
Maintain effectiveness of the Quality System components relevant to this position.
Preferred Candidates would possess:
Experience in the production of the following disciplines: gene therapy, antibodies, phage therapy, large molecules and/or vaccines
Creative, open-minded and foster an environment of inclusion of ideas and works well with all team members
Clinical and commercial phase production ability
Be proficient in upstream, downstream, and aseptic filling operations
Contract manufacturing experience
Candidates must possess:
Demonstrated ability to achieve and meet the expected production goals, financial targets of the organization.
Demonstrate exceptional leadership qualities and be a motivator of people.
Demonstrated ability execute production and direct individuals and delegate responsibilities and tasks.
Demonstrated verbal, written, and interpersonal communications skills.
Demonstrated problem solving and analytical skills and ability to lead teams in root cause analysis.
Track record of leading projects (ERP, MES, new technologies, etc.)
Proficient at utilize MS Office, spreadsheets, ERP and similar platform systems
Demonstrated technical writing ability and ability to read, understand, interpret, and apply instructions.
Be well organized and detail-oriented with proven initiative and self-starter skills.
Demonstrate knowledge and experience in cGMPs and relevant Safety Regulations (e.g., OSHA).
Be able to interact effectively with a variety of individuals within and between departments.
BS in Engineering, Biology, Pharmaceutical Sciences or related discipline
5+ years of experience in manufacturing (including 1+ years of supervision experience of employees), preferably in a process-oriented operation.
A minimum of 5 years’ experience managing a significant segment of a large manufacturer or the entire operation of a smaller manufacturer.
A career background in operations preferably in biologics, sterile and/or parenteral manufacturing.
Proven track record in controlling costs to budget, preferably manufacturing variance management.
Proven track record of successful problem solving utilizing critical thinking skills in a fast-paced environment.
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 infections and microbiome indications in oncology, immunology and neurology therapeutic areas. The Locus platform combines CRISPR-Cas3, which permanently degrades target DNA within a bacterial cell, with bacterial viruses called bacteriophage to specifically kill target pathogens while leaving non-target bacteria (i.e., the rest of the patient’s microbiome) unharmed. Locus completed its first human clinical trial in early 2021, with a crPhage product targeting Escherichia coli bacteria in the urinary tract. Locus also recently announced strategic collaborations with Johnson & Johnson, BARDA, and CARB-X to develop crPhage products targeting respiratory infections, E. coli urinary tract 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 apply online at https://www.locus-bio.com/careers/ OR email your resume or CV to email@example.com.