Scientist I

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 Formulation Development group within the 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 and gene therapies.  Perform testing services including analytical method transfer and establishment activities, analytical characterization of formulated proteins with a focus on biophysical and biochemical characterization techniques (SEC-MALS, DSC/DSF, DLS, IEX-HPLC, RP-HPLC, CE, icIEF 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. Abilities in project management and/or statistics are desirable.

Responsibilities:

• Design and execute studies for the formulation development of pharmaceutical products (Conceptualizes and proposes formulation 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 formulation development 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 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 formulation development of biotherapeutics is preferred. 

• Experience in biophysical and biochemical characterization techniques is 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 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.   

About KBI: 

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com. 

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. 

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.