Sr. Director, CMC Operations LigoCyte Pharmaceuticals
THIS JOB HAS EXPIRED OBJECTIVES:
(Briefly summarize the overall purpose of the position. Objectives should be written in 3 ? 4 statements).
1. To effectively direct the design and scale up of processes, instruments, and equipment from the
laboratory through pilot plant and manufacturing scale up.
2. To effectively direct the development, implementation, and maintenance of process methods and
equipment for the production of process formulas, technologies, and products to achieve cost
effectiveness and improved product quality.
3. To plan and implement the development of new process formulas, establish operating equipment
specifications, and improve manufacturing techniques and new process equipment production.
(Describe the primary duties and responsibilities of the job. Approximately 5 ? 10 task statements should be
1. Responsible for the development, transfer, and validation, if required, of unit processes, including
fermentation, recovery, and downstream purification for the company?s biologic drug substances,
including but not limited to recombinant proteins and monoclonal antibodies.
2. Responsible for directing development of multiple assays for screening in-vitro and in-vivo
3. Responsible for overseeing screening operations, including scheduling, assay performance, and
4. Responsible for overseeing collection and interpretation of data for biomarker and biological
characterization assays, including cell-based, multiplexed protein assays, polymerase chain
reaction, and flow cytometry methods.
5. Responsible for directing development of biochemical assays for lead validation and optimization
for disease-related targets.
6. Responsible for acting as liaison with research and/or development personnel to ensure
processes and designs are compatible.
7. Responsible for selecting, developing, and evaluating personnel to ensure the effective operation
of the function. Job Description Form
SCOPE OF SUPERVISION:
SUPERVISED NUMBER OF EMPLOYEES
Managers/Supervisors 4 0
Exempt/Professional/Technical 0 9
Non-Exempt 0 0
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
(List the education and experience required to perform the primary responsibilities of the job. Equivalent
combinations of education and experience should be noted.)
? PhD in chemistry, biochemistry, or closely related field
? Biologics and analytical development experience required; in vaccines preferred
? Track record of success required, including effectively leading and managing multi-functional
(Identify any unusual physical demands required in the performance of the primary responsibilities of the position).
? Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
(Modify text below as necessary)
? Willingness to travel to various meetings or client sites, including overnight trips. Some international
travel may be required.
? Requires approximately 20% travel.
||2155 Analysis Drive |
Bozeman, MT 59718
THIS JOB HAS EXPIRED