Bioanalysis Scientist I

BASI GAITHERSBURG LLC; Rockville (MD); On-site; USD 80,100 - 105,500; Full time

Benefits offered by this job

Health and dental coverage

401K

Paid time off

Job summary

BASI GAITHERSBURG LLC in Rockville, Maryland is seeking a highly skilled individual to develop and validate bioanalytical methods for preclinical and clinical drug development. The role requires close collaboration with team members while ensuring compliance with stringent regulatory guidelines.

The ideal candidate should hold a Ph.D. or MSc in a relevant field with 3-5 years of experience in a clinical research organization. Benefits include comprehensive health coverage and a salary range from $80,100 to $105,500 annually.

Qualifications

• 3-5 years of bioanalytical experience in pre-clinical/clinical CRO.
• Knowledge working with biotherapeutics, biomarkers.
• Experience in method development and validation for gene therapy.

Responsibilities

• Develop and validate bioanalytical methods for drug development.
• Ensure compliance with GLP, GCP, GMP and GCLP.
• Serve as principal investigator on studies.

Skills

Bioanalytical expertise

Project management

Excellent communication skills

Molecular biology knowledge

Interpersonal skills

Education

Ph.D. or MSc in relevant field

Tools

LIMS system

MS Office Suite

PCR instruments

Job description

Job Responsibilities

• Adherence to laboratory health and safety procedures
• Adherence to Standard Operating Procedures (SOPs)
• Adherence to applicable company policies and guidelines
• Adherence to federal and/or local regulations, as applicable
• Responsible for bioanalytical and assay methods development in molecular biology (DNA, RNA and protein), validation, and sample management/analysis for preclinical and clinical drug development, and biotherapeutics services tasks
• Identify and develop assays to support biological characterization of large molecules and novel technologies
• Collaborate with the director to develop innovative bioanalytical techniques in support of contemporary therapeutic strategies
• Ensure compliance is maintained with GLP, GCP, GMP and GCLP regulatory guidelines and continuing successful FDA audits
• Regularly perform method development, validation, sample analysis, and troubleshoot failures with internal and external project teams
• Create, maintain, and improve standardized tools for method development and validation activities; identify opportunities for automation to increase speed and efficiency
• Act as study principal investigator requiring timely feedback to clients on projects
• Provide directions and guidance to new and junior scientists
• Author and review technical documents (protocols, analytical reports, SOPs and raw data summaries)
• Train new staff to conduct experiments and troubleshoot experimental issues
• Present research data/posters in scientific meetings and publish scientific data in reputable journals
• Review all protocol designs prior to assignment
• Operate, maintain, and troubleshoot complex analytical instruments and techniques
• Perform other job duties as assigned

Qualifications

• Ph.D. or MSc in immunology, cell biology, molecular biology, biochemistry, biotechnology, or related field, with 3-5 years of bioanalytical experience in pre‑clinical/clinical CRO
• Knowledge/experience working with biotherapeutics, biomarkers and large molecules (proteins, peptides, monoclonal antibodies, oligonucleotides)
• Experience in method development and validation of large molecules for cell and gene therapy, pharmacokinetic (PK), toxicokinetic and immunogenicity (ADA and Nab)
• Experience with genomics platforms (qPCR, ddPCR, NGS) and ligand binding assay platforms (ELISA, ELISPOT, MSD, Luminex) and instruments under lab safety guidelines using aseptic techniques
• Experience in complex method development and validation in a GxP or CLIA and CRO environment according to FDA and industry guidance documents
• Experience interfacing with sponsors/clients on a wide range of bioanalytical method development projects
• Demonstrated expertise in bioanalytical best practices and processes
• Understanding of GLP/GCP/GMP/GCLP regulations and ability to apply practices daily
• Excellent written and verbal communication skills (English required); open, interactive style that facilitates high levels of trust
• Exceptional project management and organizational skills
• Exceptional partnering and collaboration skills with stakeholders at all levels
• Superior interpersonal skills that demonstrate high levels of emotional intelligence and critical thinking
• Self‑starter, capable of working independently to generate desired results
• Proficiency with MS Office Suite products
• Expert knowledge of molecular biology and various immunoassay platforms (fluorescence and chemiluminescence) including PCR instruments for biotherapeutics and biomarkers
• Experience with LIMS system and data acquisition software

Physical and Environmental Requirements

• General ability to read, write, speak and understand English
• Moderate physical activity: frequent walking, sitting and/or standing for extended periods of time, carrying, heavy lifting (max. 50 lbs), reaching while standing, gripping and twisting hand movements, finger control and other general repetitive motions (for more than four [4] hours per day)
• Ability to wear latex or nitrile gloves, and safety glasses as required
• Manual dexterity to operate laboratory equipment and calculator/computer
• Ability to read and interpret test results and instrument specifications

Work Environment

Work is normally performed in a typical interior office or laboratory environment. The environment involves exposure to potentially dangerous materials and situations that require following safety precautions and may include use of protective equipment. This position will frequently involve irritants, acids, bases, and other hazardous chemicals, flammable materials and bio‑hazards. Due to exposure to hazardous biological material (which may include HIV positive specimens), immunization to Hepatitis B and/or other diseases may be a requirement.

Compensation and Benefits

The pay range estimated for this position is $80,100–$105,500 annually. The salary range will adjust according to level of the role to match the candidate’s relevant experience and/or education level.

Benefits include health and dental coverage, short‑ and long‑term disability, paid time off, paid parental leave, 401K, and more.

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.