The primary objective of the Scientist II position is to support early stage product development through commercialization. The Scientist II will be expected to perform duties including, but not limited to, routine analytical testing, method development and validation, method transfer, and equipment purchase and qualifications. The Scientist II is expected to work independently with minimal supervision. The Scientist II may be assigned the responsibility of specialized compliance functions within the laboratory, such as controlled substance or reference standard management. The Scientist II will be required to write or revise SOPs, analytical procedures, analysis reports, validation documents, etc. May serve as a technical leader for internal/client based projects.
Project technical leader responsibilities.
o Accountability for the execution of analytical deliverables.
o Communicates project obstacles.
o Provides proactive communication on the technical aspects of the project to all internal stakeholders.
o Key technical interface with clients during meetings and teleconferences.
Perform testing and data peer review in accordance with written procedures for stability, clinical, formulation development, and method development/validation.
o Documents laboratory activities including notebook/worksheet, electronic notebook, and LIMS entries according to procedures that define laboratory documentation practices.
o Processes electronic data using procedures that ensure data integrity and security.
o Performs and documents daily standardization and performance verifications on laboratory equipment.
o Reviews and countersigns (as appropriate) logbooks, notebooks and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity and accuracy of calculations.
o Performs controlled substance chain of custody documentation and reconciliation.
o Evaluates and interprets test and experimental data, draws conclusions based on results, and documents and communicates work appropriately.
o Resolves technical issues and interprets and uses experimental data to expand on assignments whenever possible.
o Troubleshoots technical procedures, methodology and instrumentation.
o Transcribes results onto analysis reports, LIMS or stability summary sheets.
Performs method development/validation and method transfer.
o Develops analytical methods for dissolution and chromatographic analysis.
o Authors/reviews validation and method transfer protocols.
o Acts as subject matter expert for analytical technology transfer.
Authors/reviews analytical protocols, SOPs, reports and related documentation.
Authors/reviews laboratory investigations. Conducts investigations, determines root cause and documents results, as needed, in compliance with SOPs.
Ensures laboratory reference standards are maintained in compliance with controlled substance and site SOPs and the site EH&S manual.
Assists with periodic maintenance/calibration of laboratory equipment.
Assists laboratory management with acquisition, upgrade and qualification of instruments.
Complies with site wide and departmental procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety and electronic data security.
Minimum Job Qualifications
Bachelor?s Degree in chemistry or related scientific discipline is required.
Minimum of three (3) years of work experience in pharmaceutical or related laboratory work is required. Hands on experience with pharmaceutical analytical development is required.
Demonstrates advanced technical knowledge of analytical methods. Working knowledge of GLP/cGMP regulations and safety procedures.
Maintains knowledge of pertinent literature, regulatory guidelines, laboratory techniques and instrumentation relevant to the discipline, area or section.
Knowledge of Analytical Development operations and ability to support and coordinate projects in various stages of the development process.
Good technical writing and communications skills.
Good interpersonal skills and ability to work effectively in a team environment and client companies.
Demonstrates project management skills. Ability to react quickly to changes in project priorities and timelines.
Extensive experience in the use of computers for analysis of data and generation of reports and in the use of software packages including Microsoft Office (Word, Excel, and Outlook).
Experience with electronic document management systems (Veeva) and chromatography data management software (Empower/Chemstation).
Ability to support multiple projects simultaneously and serve as a senior technical contributor and/or independent project team member. May act as a project team lead.
Candidates should demonstrate a general understanding of chromatographic techniques and basic trouble shooting skills for typical High Performance Liquid Chromatography (HPLC) and Gas Chromatography
(GC) related problems.
Physical and Mental Demands and Work Environment
The physical and mental demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
While performing the duties of this job, the employee is frequently required to sit, stand or walk. The employee is occasionally required to climb or balance; and stoop, kneel, or crouch.
The employee must occasionally lift and/or move up to 10-20 pounds.
Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus. Must have corrected visual acuity of 20/40 or better bilaterally. Must be able to pass color/contrast testing passing 9 of 12 elements.
The employee may be required to pass a Pulmonary Function Test (PFT) and regularly be required to wear appropriate Personal Protective Equipment (PPE) such as a respirator (Bullard, 3M) for extended periods
of time in order to perform specific job duties.
While performing the duties of this job, the employee is regularly required to use English written and oral communication skills; read and interpret data, information and documents; analyze and solve non-routine office administrative problems; use math and mathematical reasoning; observe and interpret situations; learn and apply new information skills; perform detailed work on multiple, concurrent tasks; work under deadlines with moderate interruption; and interact with the department staff and others outside the department.
In certain assignments, the employee will regularly work near moving mechanical parts. The employee will occasionally work around or with fumes, airborne particles, and/or toxic or caustic chemicals.
The employee works under typical office conditions, and the noise level is usually moderate. The employee must wear personal protective equipment per site policies and SOPs.