Associate Scientist, Process Development

Process Development Associate Scientist

If the following job requirements and experience match your skills, please ensure you apply promptly.

Description :

The PD Associate Scientist provides process development input and co-ownership for a product, including all development and design decisions, with oversight and mentorship from senior process development staff.

They learn to apply scientific principles to design and execute laboratory studies for unit operation development and optimization.

They possess a developing working knowledge of the functional area with developing aptitude in one or more operations. They author and review technical documents including protocols and reports commensurate with PD compliance and quality standards.

This workflow encompasses process development scope as well as support of technology transfer activities in preparation for cGMP production.

• The PD Associate Scientist is responsible for maintaining training compliance, according to site expectations. This is a salaried exempt position, with the expectation to cover shift work as needed to support laboratory activities and organizational need.
• Executes process development, process characterization, and technology transfer of microbial processes to commercial cGMP facility.
• Works toward developing a broad knowledge of state-of-the-art principles and theory.
• Responsible for producing high quality documentation and client reports suitable for publication and regulatory requirements.
• Supports process development efforts in the laboratory and manufacturing areas. Executes experiments with oversight and support.

Conceptualizes and proposes process development and manufacturing based on process data.

• Experience with chromatography skids is preferred.
• Provide technical support for cGMP manufacturing through floor coverage, batch document review, and support of deviations and change controls with mentor / managerial oversight.
• Responsible for developing / maintaining a current understanding of cGMP and other regulatory requirements.
• Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.

Requirements :

B.S. degree and a minimum of 4+ years of related experience; M.S. and 2+ years of related experience.

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

Prepares documents using own and others’ data; organizes, clarifies, and presents information for internal and external audiences using commonly available software such as MS Office.

Reasoning Ability : Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions and deal with several 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.

Computer Skills : Word Processing, Spreadsheets, Power Point, E-mail

Salary Range : 80,000 90,000

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.

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