Lead Scientist – Manufacturing Upstream
Kashiv BioSciences, Inc.
This is a Full-time position in Piscataway, NJ posted November 28, 2021.
Posted Date 2 days ago (11/16/2021 2:12 PM)
ID 2021-2702
Company Kashiv BioSciences LLC.
Overview
At Kashiv Biosciences, LLC we unite caring with discovery to make life better for patients around the world.
Kashiv BioSciences is a fully integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline.
We are looking for an experienced Upstream Lead to join our Piscataway, NJ Manufacturing team.
Responsibilities
SUMMARY:
The Upstream Lead is a hands-on position responsible for running the daily operation of Kashiv’s cell line development and upstream manufacturing function.
The lead is responsible for handling shift and upstream team who will be involved in manufacturing of monoclonal antibodies.
This position requires technical expertise in cell culture processes & bioreactor operations.
The lead will also be responsible for the all the QMS documents (CAPA, deviations, Change management, risk assessment etc.) related to upstream manufacturing process.
- Provide functional leadership and subject matter expertise to establish cell culture based recombinant protein production processes at multiple scales.
- Lead process transfer, scale-up activities.
- Provide hands on and strategic leadership to a team operators and engineers to support company goals and activities
- Develop and maintain productive relationships with internal and external collaborators and partners.
Education and Experience
- Bachelor’s, Master’s degree, or Doctoral degree in chemical, biological, or biochemical sciences with experience in commercial biotech
- At least 4 years industry based experience in upstream monoclonal antibodies manufacturing process.
- Industry based cell culture manufacturing experience.
- Demonstrated ability to function effectively across a matrix organization
- Outstanding organizational and communication skills (especially technical writing, verbal and presentation), and excellent supervisory skills
- Knowledge of current GMPs, and FDA and / or European validation practices for biopharmaceutical processes.
Work Environment & Physical Demands:
General work environment and physical demands as required to successfully perform the essential functions of this job.
Ability to work flexible hours as needed.
Ability to work under pressure and meet deadlines.
Some travel may be involved.
Supervisory Responsibility, if any : Yes
This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.
Kashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.
In addition to federal law requirements, Kashiv BioSciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.
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