JOB SUMMARY
The Downstream Process Development (PD) Scientist I 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 can apply scientific principles to design and execute laboratory studies for unit operation development and optimization. They possess a developing working knowledge of the downstream functional area with strong aptitude in one or more operations, including chromatography and tangential flow filtration. 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 Scientist I 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. Compiles and presents data to clients.
- Supports downstream 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. Execution includes downstream unit operations such as chromatography, tangential flow filtration, normal filtration, as well as sampling and basic analysis of process samples; concentration, pH, and conductivity.
- Will lead the downstream portion of development, process characterization, and/or technology transfer programs, acting as subject matter expert (SME), and directing the efforts of the team in meeting the project deliverables.
- 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.
- Conceptualizes, proposes and executes the evaluation, development and implementation of new downstream technologies leading to process improvements and efficiency of operation in support of downstream process development and manufacturing activities.
- Documents procedures, observations, and results in laboratory notebooks and responsible for maintaining training compliance, according to site expectation. Reviews documentation and records as assigned.
REQUIREMENTS
- B.S. degree and a minimum of 5+ years of related experience; M.S. and 3+ years of related experience or Ph.D. and 0+ years related experience in a scientific discipline.
- Experience with downstream process development and chromatography equipment required. Excellent written and verbal communication skills, focus on customer service, and ability to meet strict client deadlines. Highly collaborative. Flexibility of hours to support downstream processes. Knowledge of GMPs and biotechnology-derived product regulations preferred.
- 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; 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 in order to diagnose or troubleshoot.
- Computer Skills: Word processing, Spreadsheets, Power Point, E-mail.
- Equipment Use: Computer and lab equipment.
SALARY RANGE: 90,000 - 110,000
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.
Top Skills
What We Do
KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally.
With each of our 500+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs.
KBI is proud to be a JSR Life Sciences Company.
.jpeg){kind=icon}
