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Senior Scientist I

2 months ago

Franklin, United States B2S Life Sciences LLC Full time
Job DescriptionJob DescriptionDescription:

The Senior Scientist I– Bioanalytical Scientific Strategy is a part of the Assay Development team which designs and executes assays that complement the company's capabilities in custom critical reagents to enable clients to efficiently make data-driven decisions for optimal analytical outcomes to support biotherapeutic drug development.

B2S offers a range of services from drug discovery through nonclinical/clinical development. This includes early phase ADME investigations, reagent optimization, generation of optimal matched pair of antibodies, method qualification, and non-GLP sample analysis.


The Senior Scientist I– Bioanalytical Scientific Strategy develops, documents, and qualifies large molecule bioanalytical methods including, but not limited to PK/TK, immunogenicity, and biomarker assays to support a range of nonclinical/clinical studies.

The individual in this role ensures quality and regulatory requirements for good laboratory practice (GLP) are followed.


Essential Duties and Responsibilities:

· Performs all duties and responsibilities of the Scientist III with increased scientific oversight and independence.

· 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.

· Perform a variety of assays including conventional Enzyme Linked Immuno Sorbent Assay (ELISA)/Electrochemiluminescence (ELISA/ECL) immunoassays as well as biophysical/biochemical/bioanalytical characterization techniques including bio-layer interferometry.

· May function as Principal Investigator on regulated studies.

· Serves as a Scientist for clients’ projects.

· Can communicate independently with the client.

· Oversees the development and qualification of large molecule bioanalytical methods.

· Oversees bioanalytical assay qualification, validation, and/or sample analysis to support.

· pharmacokinetics (PK), anti-drug antibodies (ADA), and biomarker assessments.

· Compile scientific data (including analysis and technical writing) in an intelligible format suitable for a professional audience.

· Complete sample analysis and method qualifications.

· Complies with all applicable regulations and maintains proper records in accordance with standard operating procedures (SOPs) and policies.

· Complies with application able regulations (GXP)

· Design and develop new bioanalytical methods primarily based on ligand binding assays to support the development of large molecule therapeutics.

· Generates R.C.F.’s for all products to ensure that it undergoes appropriate review and signatory process.

· Independently applies basic scientific principles, performs literature searches, attends scientific meetings, and keeps up to date on literature in the biotherapeutic bioanalysis field.

· 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.

· Maintain laboratory equipment, as needed.

· Maintains proper records in accordance with standard operating procedures (SOPs) and policies.

· Performs protein conjugation chemistry.

· Records and notes the experimental processes on time and in a correct documentation format.

· Records and tracks samples for the controlled inventory.

· Report and treat data with prominent level of integrity and ethics.

· Review data associated with method investigations, development, and qualification efforts.

· Troubleshoot existing analytical methods.

· Writes, edits, and revises standard operating procedures (SOPs), qualifications, and forms.

· Perform other duties as assigned.


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:

· Ethics

· People Skills

· Organizational Support

· Teamwork

· Adaptability

· Quality and Quantity – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality; Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly but efficiently.

· Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.

· Safety and Security – Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.

· Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.

· Oral and Written Communication – Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings; Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Reads with the ability to interpret written information.

Requirements:


Education and/or Experience:

· Bachelor’s Degree (B.S.) with at least five-years of direct laboratory experience, or a master’s degree (M.S.) in chemistry or a related science with at least three-years of direct laboratory experience.

· ELISA/Ligand Binding Assay experience.

· The ability to adapt and conform to shifting priorities and demands and execute accordingly.

· Strong organizational and communication skills, both written and verbal.

· The position may require evening and weekend work, domestic travel, and a valid driver’s license.

· Computer software skills required including Microsoft Office Suites.

· Individuals 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.



Other Skills and Abilities:

· Computer software skills including Microsoft Office Suite (Outlook, Word, PowerPoint, Publisher, and Excel), Lockbox LIMS, Salesforce, SharePoint, and Paylocity.

· The ability to maintain professional certifications.

· The ability to maintain confidentiality.

· The ability to develop positive working relationships and interact effectively with clients and colleagues.

· The ability to develop a broad knowledge in field of expertise, including the ability to interpret current literature relevant to research and development (R&D) projects, and visibility outside of the functional area.

· A working knowledge and 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.

· Knowledge of good laboratory practice (GLP), and Organization for Economic Co-operation and Development (OECD) regulations and the ability to apply this knowledge.

· Knowledge of good manufacturing practice (GMP), good clinical practice (GCP), the International Conference on Harmonization (ICH), and other related guidance.

· Knowledge of bioanalytical approaches for advanced therapeutic modalities including monoclonal antibodies, fusion proteins, and peptides.

· A working knowledge and understanding of global regulatory guidance documents and relevant industry whitepapers.

· The ability to analyze and evaluate data, make determinations, and 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, including exercising 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 extended periods, under time pressure, and 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.

· 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.


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/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.