Process Development Associate

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.

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.

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.

REQUIREMENTS :

Knowledge, Skills, Abilities :

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.

Rotating / Set shift work is expected to support active laboratory operations when necessary.

SALARY RANGE : 50,000 65,000 plus a 10% shift premium

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.