Associate Research Scientist / Research Scientist

Smithers - Medical Device Testing; Gaithersburg (MD); On-site; USD 75,000 - 117,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401K retirement plan

Paid time off

Job summary

Smithers PDS LLC (Pharmaceutical Development Services) is seeking an Associate Research Scientist or Research Scientist with expertise in bioanalytical assays (PK, ADA, Nab) to design, develop and validate new assays. This exempt role typically requires 40+ hours per week and offers salaries ranging from $75,000 to $100,000 for Associate or $86,000 to $117,000 for Research Scientist.

The position provides comprehensive benefits including health insurance, dental and vision coverage, a 401(k)

Qualifications

• BA/BS in Biological or Physical Sciences with 3–5 years of relevant experience or MS with 1–2 years of experience (Associate).
• BS/BA with 5+ years immunological assay development; MS with 4 years; PhD with 2 years (Research Scientist).
• Understanding of bioanalytical assays across platforms; experience supporting method development and validation; assay troubleshooting.

Responsibilities

• Design, development and feasibility of new assays.
• Adherence to SOPs and regulatory guidelines (GLP/GCP/CLIA).
• Collaborate and provide guidance to junior scientists as needed.

Skills

Bioanalytical assays

Immunological assay development

Assay troubleshooting

Training juniors

CRO/GLP/GCP/CLIA experience

Education

BA/BS in Biological or Physical Sciences

MS in relevant field

PhD in biology/life sciences/chemistry

Tools

Watson LIMS

MS Word/Excel

Statistical software

Job description

Smithers PDS LLC (Pharmaceutical Development Services) brings new drugs to market by providing pre-clinical and clinical services for all phases of drug development. PDS works with customers to develop new methods, validate existing methods, as well as performing the assays necessary to analyze samples from patients on more than 100 clinical trials currently in different phases of the FDA regulated drug approval process. Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories. Smithers is seeking a talented Associate Research Scientist or Research Scientist with expertise in bioanalytical assays (PK, ADA, Nab). The job level will be commensurate with previously related experience. The individual will be responsible for design, development and feasibility of new assays. This position is salaried and is classified as an exempt position. Exempt employees typically work 40 hours or more to adequately perform their responsibilities. Extended work hours may be necessary to support the business in meeting client deliverable commitments. The annualized salary range for an Associate Research Scientist or Research Scientist position is $75,000 - $100,000 or $86,000 - $117,000, respectively. Experience and qualifications will determine salary and job level. Smithers PDS offers a comprehensive health insurance package including a choice of 3 medical plans, dental insurance, vision insurance, 401K retirement plan and PTO.

The Qualifications For This Role Are

• Associate Research Scientist:
  • BA/BS in Biological or Physical Sciences and at least 3 - 5 years of relevant experience; or
  • MS in relevant field and at least 1-2 years of relevant experience
• Research Scientist:
  • BS/BA in biology, life sciences, or chemistry field and at least 5 years’ experience in immunological assay development; or
  • MS in biology, life sciences, or chemistry field and 4 years’ experience in immunological assay development; or
  • PhD in biology, life sciences, or chemistry field and 2 years’ experience in immunological assay development;
• Understanding of bioanalytical assays (various design and platforms)
• Experience supporting or leading method development and validation studies
• Experience with assay troubleshooting
• Ability to assist with training and provide technical guidance to more junior scientists as needed
• Prior CRO and GLP, GCP, and/or CLIA experience a plus
• Experience with automated laboratory systems a plus
• Experience in drafting SOPs a plus

Corporate 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
• Ensures appropriate reporting when there is reason to believe compliance with regulations, policies, guidelines, SOPs, quality, or other criteria are not being observed or enforced
• Ensure materials and equipment are maintained

Standard Requirements

• Excellent oral and written communication skills
• Proficient in advanced computer applications including MS Word, Excel, statistical programs, and Watson LIMS database
• Able to work independently and manage priorities, as well as operate as a team member
• Must be solution oriented and open to input
• Must be able to comfortably and successfully operate in a dynamic environment with shifting priorities
• Must be able to collaborate and partner at all levels of the organization to accomplish deliverables and meet quality standards

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