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Position Summary:
Join a highly technical analytical team in a dynamic work environment as a member of the Analytical, Formulation and Stability (AFS) department and participate in contracted client analytical programs for monoclonal antibodies, recombinant proteins, and peptides. Perform testing services including GMP testing, analytical method transfer activities, analytical method qualification/validation activities with a focus on separations technologies (HPLC, UPLC, western blot, SDS-PAGE, CE-SDS). Abilities in other analytical techniques applicable to the business needs are desirable (Biophysical methods, ELISA, qPCR, etc).
Position Responsibilities:
Design and execute product development efforts in the process, formulations, and analytical development areas. Conceptualizes and proposes process development, formulations development and analytical development strategies based on bio-pharmaceutic data.
Responsible for producing high quality documentation, client reports, etc. suitable for publication and regulatory requirements.
Review and analyze data for the experiments performed by self and by other analysts.
Responsible for the equipment within the AFS team and ensure operational status of instruments and equipment
Responsible for developing/maintaining a current understanding of cGMP and other regulatory requirements.
Maintain broad knowledge of state-of-the-art principles and theory; provides technical leadership in the group, serves as in-house advisor on key scientific discipline areas.
Build collaborative relationships with customers and provide scientific presentations to clients.
Able to react to change productively and handle other essential tasks as assigned
Position Requirements:
Ph.D. and 0-2 years directly related experience or Master's and sevenyears related experienceorBachelor's and nineyears related experience inbiotechnology or pharmaceutical industries.
Experience in chromatographic and electrophoretic analytical techniques are preferred.
Good oral presentation and technical writing skills are required.
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.
Understanding of biotherapeutic regulatory requirements and expectations.
Strong communication skills.
Salary:$85,000-$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.