Senior Scientist I

Location: Franklin Indiana

Principal Function: The Senior Scientist I is responsible for generation, characterization,

and life cycle management of custom critical reagents to develop robust assays for

regulated bioanalysis to support evaluations of pharmacokinetics (PKs), toxicokinetic (TKs),

immunogenicity of biotherapeutics and biomarkers. The Senior Scientist I will write and maintain documentation for methods and/or reagents and will assist the Lab Manager/Scientist with common laboratory tasks.

Essential Duties and Responsibilities: 

• Performs all duties and responsibilities of the Scientist II with increased scientific oversight and independence.
• Serves as a Scientist for clients’ projects.
• Performs a variety of protein purification and biophysical/biochemical/bioanalytical characterization techniques including, various protein preparative and analytical chromatographic techniques, sodium dodecyl sulfate–polyacrylamide gel electrophoresis (SDS-PAGE), Western blotting, conventional Enzyme Linked Immuno Sorbent Assay (ELISA)/Electrochemiluminescence (ELISA/ECL) immunoassays, Bradford assays, HABA biotin quantitation, and bio-layer interferometry.
• Performs protein conjugation chemistry.
• Compiles scientific data (including analysis and technical writing) in an intelligible format suitable for a professional audience.
• Records and notes the experimental processes on time and in a correct documentation format.
• Reports and treats data with prominent level of integrity and ethics.
• Complies with application able regulations (GXP); maintains proper records in accordance with standard operating procedures (SOPs) and policies.
• Independently designs and performs scientific experiments with a pre-defined goal including developing new methodologies, protocols, and/or test procedures that contribute to core group research goals and reflect expert knowledge.
• Writes, edits, and revises standard operating procedures (SOPs), qualifications, and forms.
• Complies with all applicable regulations and maintains proper records in accordance with standard operating procedures (SOPs) and policies.
• Independently applies basic scientific principles.
• Performs literature searches.
• Attending scientific meetings.
• Keeps up to date on literature in the biotherapeutic bioanalysis field.
• Records and tracks samples for the controlled inventory.
• Generates R.C.F.’s for all products to ensure that it undergoes appropriate review and signatory process.
• Builds and improves the inventory management system.
• Orders laboratory supplies, as needed.
• Maintains laboratory equipment, as needed.
• Assists the Business Coordinator and the CEO in expanding the exporting capabilities of B2S Life Sciences.
• Provides back-up for the Associate Director of Custom Reagent Development Team, as needed, and Associate Directors of other departments, as requested.
• Other duties as assigned.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty according to the requirements of the Organization. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform their essential duties and responsibilities.

Competencies: 

• Adaptability
• Analytical
• Ethics
• People Skills
• Oral and Written Communication 
• Problem Solving 
• Organizational Support
• Quality and Quantity
• Safety and Security 
• Teamwork

Education and/or Experience:

• Ph. D Degree in a scientific field.
• B.S / M.S. in a scientific field with 5 to 10+ years related experience.
• Previous lab experience is required.

Other Skills and Abilities: 

• Computer software skills including Microsoft Office Suite (Outlook, Word, PowerPoint, Publisher, and Excel), Lockbox LIMS, Salesforce, SharePoint, and Paylocity are required.
• The ability to maintain professional certifications.
• The ability to maintain confidentiality.
• Develop positive working relationships and interact effectively with clients and colleagues.
• Develop a broad knowledge in field of expertise.
• Ability to interpret current literature relevant to research and development (R&D) projects, and visibility outside of the functional area is required.
• Expertise in the development of custom reagents, Ligand Binding Assays (LBAs), antibody generation and characterization, and assay development and validation.
• The ability to troubleshoot bioanalytical problems.
• The ability to perform analysis and interpretation of data from analytical instrumentation.
• A working knowledge of the development of biotherapeutic drugs.
• A working knowledge and expertise of protein chemistry and isolation and characterization of proteins.
• A working knowledge of good laboratory practice (GLP), and Organization for Economic Co-operation and Development (OECD) regulations and the ability to apply this knowledge.
• A working knowledge of good manufacturing practice (GMP), good clinical practice (GCP), the International Conference on Harmonization (ICH), and other related guidance and the ability to apply this knowledge.
• A working knowledge of bioanalytical approaches for advanced therapeutic modalities including monoclonal antibodies, fusion proteins, and peptides.
• Understanding of global regulatory guidance documents and relevant industry whitepapers.
• The ability to analyze and evaluate data,
• The ability to make determinations based on data.
• The ability to clearly and concisely present findings in oral, written, or electronic format.
• The ability to listen, communicate complex ideas in a public forum, and develop good relations with the larger business community.
• The ability to remain calm, perform duties, problem-solve, and make sound and rational decisions.
• Exercise independent judgment within established protocols and guidelines.
• The ability to maintain a high motivation level to overcome challenges, develop and implement effective strategies, and quickly adapt to new responsibilities.
• The ability to work alone with minimum supervision and with others in a team environment.
• The ability to work rapidly for lengthy periods of time, under pressure.
• The ability to manage and prioritize multiple projects simultaneously.
• The ability to document daily work in an accurate, concise, and timely manner.
• The ability to interact professionally and constructively with clients, team members, and co-workers.
• The ability to be sensitive to professional ethics, gender, cultural diversities, and disabilities is required.
• The ability to operate a computer, printer, telephone, copy machine, scanner, fax machine, and other office equipment.
• The ability to apply standard office practices and organization skills to a variety of interrelated processes, tasks, and operations.
• The ability to travel out-of-town on company business and/or to attend or speak at conferences and training events.
• The ability to telecommute effectively and efficiently while traveling is required.

Physical Demands

• Ability to stand less than 1/3 of the time.
• Ability to walk less than 1/3 of the time.
• Ability to sit more than 2/3 of the time.
• Ability to talk or hear from 1/3 to 2/3 of the time.
• Ability to lift 20 lbs. less than 1/3 of the time.

Work Environment

• The work environment is in an office and laboratory environment.
• Travel up to 5% percent of the time.
• Frequent use of a computer.
• This position requires working independently, as well as part of a team.
• While performing the duties of this job the noise level in the work environment is usually moderately loud and has moderate temperatures.
• Personal protective equipment must be worn in designated lab areas: closed-toed shoes, laboratory coat, safety goggles, and gloves.
• This position requires the use of all general office and lab equipment.
• Potential exposure to pathogens.

This position may require work beyond business hours on weekends and holidays. A valid driver’s license is required as it may be necessary to drive one’s personal vehicle on B2S Life Sciences business.