MedPharm
Scientist, HPLC
Analytical - Durham, NC - Full Time
General Information
Position Summary – Act as a lead analytical scientist on assigned studies. Assist with study plan review, sample preparation, chromatographic analysis, data processing and interpretation, and report writing. To perform experiments, ensuring that projects are completed to plan, while complying with all quality and safety regulations.
Essential Functions
While performing the duties of this job, there may be certain physical demands required for the position.
Other Duties
You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.
Limitations and Disclaimer
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
| Title: Scientist, Bioanalytical | Date: XXX |
| Site: Durham, NC FLSA Status (US Only): Exempt/Non-Exempt | Department: XXX Reporting To: Director |
Position Summary – Act as a lead analytical scientist on assigned studies. Assist with study plan review, sample preparation, chromatographic analysis, data processing and interpretation, and report writing. To perform experiments, ensuring that projects are completed to plan, while complying with all quality and safety regulations.
Essential Functions
- Perform chromatographic analyses to support performance testing and bioanalytical activities such as permeation and penetration studies, release investigations, extractions, stability studies and regulated sample analysis.
- Develop ‘fit for purpose’ methods for the analysis of in vitro samples in support of Sponsor R&D projects; Show proficiency in U/HPLC use, troubleshooting and maintenance.
- Validation of analytical methods according to the appropriate regulatory guidance.
- Support the implementation and growth of the formulation development group at MedPharm US by analyzing pre-formulation and solvent system stability samples (experience with developing stability indicating methods is desired).
- Lead and work effectively in small cross-functional teams; Provide technical expertise to analytical group in addition to other internal teams
- To promptly record all data using Good Documentation Practices as per MedPharm US procedures.
- Report any amendments or deviations from study plans/ testing protocols to the Study Manager/ Management as appropriate.
- Serve as technical support in root cause failure analysis
- Confer with scientists to conduct analyses of research projects, interpret test results, or develop nonstandard tests as needed.
- Prepare test solutions, compounds, or reagents for laboratory personnel to conduct tests.
- Maintain laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed.
- To adhere to MedPharm’s procedure and guidance documents.
- To adhere to MedPharm Health & Safety Policy and OSHA regulations at all times and to ensure the safety of others in any procedures or tasks performed.
- Any other duties and/or tasks that may be assigned.
- Communication: Exhibits good listening and comprehension; Expresses ideas and thoughts in written form; Expresses ideas and thoughts verbally; Keeps others adequately informed; Selects and uses appropriate communication methods
- Cooperation: Displays positive outlook and pleasant manner; Establishes and maintains effective relations; Exhibits tact and consideration; Offers assistance and support to co-workers; Works actively to resolve conflicts; Works cooperatively in groups
- Initiative: Asks for help when needed; Looks for and takes advantage of opportunities; Seeks increased responsibilities; Takes independent actions and calculated risks; Undertakes self-development activities; Volunteers readily
- Dependability: Commits to doing the best job possible; Follows instructions, responds to management direction; Keeps commitments; Meets attendance and punctuality guidelines; Responds to requests for service and assistance; Takes responsibility for actions
- Adaptability: Accepts criticism and feedback; Adapts to changes in the work environment; Changes approach or method to best fit the situation; Manages competing demands
- Quality: Applies feedback to improve performance; Demonstrates accuracy and thoroughness; Displays commitment to excellence; Looks for ways to improve and promote quality; Monitors own work to ensure quality
- Bachelor’s degree (4 years)
- 5 up to 7 years
- Must be experienced in HPLC sample analysis and method validation. Experience in HPLC method development is desirable.
- Understanding of analytical separation techniques, including reverse-phase, ion exchange, and HILIC.
- Comfort working with both large and small molecules
- Familiarity with FDA and ICH guidelines for bioanalytical work
- Must have a meticulous approach to work and be highly organized.
- Good communication skills, both written and oral.
- Comfortable presenting technical information and addressing technical questions.
- Must be able to multitask, manage time efficiently and be able to prioritize.
- Must be able to work independently and in a team environment.
- Must be able to read & comprehend simple instructions
- Must be able to effectively present information in one-on-one & small group situations to customers, clients, & other employees.
- Deal with problems involving several concrete variables in standardized situations.
- Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
- Microsoft Office (Word, Excel, PowerPoint, Access, Publisher, Outlook, Internet Explorer)
- Specialty Software: Experience with Waters Empower or Shimadzu LabSolutions is preferred
While performing the duties of this job, there may be certain physical demands required for the position.
Other Duties
You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.
Limitations and Disclaimer
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
