Process Development Associate

Job Summary:

This position resides in the Process Operations team in the Process Development department and drives robustness and consistency in the laboratory through execution and innovation of laboratory practices. They drive efficiencies in Process Development while maintaining ownership of the laboratory and systems.

They will have the responsibility of being operations leads on projects with increasing ownership and collaboration within the department. Through defined roles and responsibilities, the process operations team will be subject matter experts (SMEs) on both the execution of processes as well as the systems in the laboratory. The Process Development Associate supports and executes laboratory studies within the KBI Process Development organization at KBI under general supervision.

The Process Development Associate is able to execute lab work, with documentation and reporting that is consistent with Process Development compliance and Quality standards. The Process Development Associate is able to author basic operational documents for routine unit operations within the laboratory organization.

The Process Development Associate is capable of executing lab studies from written documents and applies standard scientific approaches to solving technical problems. The Process Development Associate may serve as the point of contact for a specific laboratory project. The Process Development Associate works under the general supervision of laboratory management with work reviewed for soundness and accuracy.

The Process Development Associate will have a basic understanding of Process Development methods/unit operations as well as scientific principles in order to execute lab studies. The Process Development Associate will have the ability to execute laboratory experiments from written/verbal instruction.

Basic technical writing and communication skills are desired. Basic understanding of laboratory equipment and equipment maintenance are required. The Process Development Associate participates in process development meetings and technical investigations if needed.

Experience in various stirred tank fermentations (single-use and stainless), chromatography, precipitation, and filtration methods are highly preferred. The Process Development Associate will assist in the evaluation, development and implementation of new technologies leading to process improvements and efficiency of operations. The Process Development Associate will identify and implement continuous operation improvement ideas as a major part of this role.

JOB DESCRIPTION T-0094 Rev 0 Job Description Template The Process Development Associate will be responsible for maintaining training compliance, according to site expectations. The Process Development Associate is a salaried, exempt position, with the expectation to work off-hours shift work when necessary, depending on laboratory activities and organizational need. The position offers salary differential incentive for working off-hours on a consistent basis.

Responsibilities:

• Conducts laboratory experiments in support of process development including preparing solutions, running unit operations (fermentation, homogenization, clarification, filtration, chromatography, etc.), and executing basic analysis of process samples (absorbance, solids content, plating, pH, conductivity, metabolites, etc.). Documents these procedures, observations, and results in electronic laboratory notebooks.

• Normally exercises judgment within defined procedures and practices to determine appropriate action (sometimes called upon to exercise judgment outside of defined procedures).

• Makes detailed observations about experimental deviations from the expectations and carries out elementary analysis of the data to determine data that should be rejected as a result of exceptional laboratory conditions.

• Understands experiments and conducts troubleshooting analysis.

• Maintains and updates knowledge of instrumentation and maintenance. Schedules periodic maintenance for laboratory equipment.

• Assures proper labeling, handling, and storage of all chemicals used in the area; assures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures, and attends all required safety and health training, including handling hazardous waste.

• Able to react to change productively and handle other essential tasks as assigned.

Requirements: A.S. specifically in Biotechnology or associated field, or B.S. degree in microbiology, biochemistry, chemistry, engineering, or related area (with equivalent training). A.S./B.S. and 0+ years of related experience.

Language Ability: Records (accurately, clearly, and consistently) information, facts, and measurements that are required by cGMP, GLP, and/or by co-workers to understand situations and to perform their assignments.

Ability to read, analyze, and interpret technical procedures. Ability to author reports, operating procedures, and technical documents. Ability to effectively present information and respond to questions from groups of managers.

Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.

Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.

Math Ability: Understands and applies mathematical concepts and methods. Interprets data and results using quantitative measures and statistical analysis where necessary; performs and documents calculations and conversions as part of standard processes; develops tests and methods to assure accuracy of processes and measures; learns and applies new quantitative concepts; performs calculations to diagnose or troubleshoot.

Equipment Use: Computer and lab equipment.

Salary Range: 55,000 - 65,000

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed.

I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.