Process Development Associate Scientist

Position Summary:

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.

Responsibilities:

• 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.
• Will assist in the upstream portion of development, process characterization, and/or technology transfer programs.
• 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.
• Able to react to change productively and handle other essential tasks as assigned.

Requirements: 

• B.S. degree and a minimum of 4+ years of related experience; M.S. and 2+ years of related experience.
• Experience with common molecular biology lab techniques required (transformation, PCR, PAGE, etc.). Additional experience with microbial fermentation preferred.
• Excellent written and verbal communication skills are required.
• Must be organized and able to focus in a fast-paced, multi-tasked environment, while maintaining operational efficiency and positive demeanor.
• Must demonstrate the ability to collaborate and work with teams.
• Demonstrated ability to innovate new and existing workflows.

Salary Range: $84,000-$105,000

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.