At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.
Position Summary:
Join a highly technical analytical team in a fast-paced work environment as a member of the Particle Characterization Core within the Rapid Analytics (RA) group of Analytical and Formulation Sciences (AFS) department. Participate in analytical testing and program leadership for contracted client formulation development programs for products including, but not limited to, monoclonal antibodies, recombinant proteins, peptides, AAVs, and gene therapies. Perform testing services including analytical method transfer and establishment activities, analytical characterization of formulated proteins with a focus on particle characterization and biophysical techniques (MFI, HIAC, NTA, AUC, RMM, RMS, FTIR, PCR, SEC-MALS, HPLC, and more). Program leadership from working with clients to determine scope of work through technical writing of results, including data interpretation and communication of results in client meetings.
Responsibilities:
Design and execute studies, perform analytical testing for characterizing particulate content of pharmaceutical products.
Responsible for producing CGMP documentation, client reports, etc. suitable for batch support, lot release reporting, and regulatory requirements.
Review and analyze data for the experiments performed by self and by other analysts.
Responsible for the equipment within the Particle Characterization team and ensure operational status of instruments and equipment.
Maintain broad knowledge of up-to-date principles and theory; provides technical leadership in the group, serves as in-house advisor on key scientific discipline areas.
Responsible for developing/maintaining a current understanding of CGMP, national and international compendia, and other regulatory requirements.
Lead client-facing programs which includes defining and communicating project scope and timelines, maintaining consistent communication with client, and facilitating routine technical presentations.
Requirements:
Ph.D. and 0-2 years directly related experience or Master's and 5 years related experience or Bachelor's and 7 years related experience in biotechnology or pharmaceutical industries.
Experience with particle characterization of biotherapeutics is preferred.
Experience in biophysical and biochemical characterization techniques is preferred.
Good oral presentation and technical writing skills are required.
Records (ALCOA++) 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.
Laboratory position, 90-100% on-site expected.
Salary Range: $84,000 - $115,500
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, 401K matching with 100% vesting in 60 days and employee recognition programs.
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.
