Scientist, Bioanalytical

Job Title: Scientist, Bioanalytical (HPLC)

Location: Durham, NC

Reports to: Director

On-Site Expectations:

• 100% on-site position
  
  

About MedPharm:

MedPharm is a global leader in topical and transdermal product development, providing end-to-end services from early-stage formulation development to full commercial production. With facilities in the UK and the US, MedPharm has established itself as a trusted partner in dermatological, nail, mucosal, respiratory, and transdermal drug delivery. MedPharm has a strong track record of supporting product development and pioneering performance testing models to reduce development risks for its clients.

Job 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 Duties And Responsibilities

To perform this job successfully, an individual must be able to perform the following satisfactorily; other duties may be assigned. Reasonable accommodation may be made to enable individuals with disabilities to perform the 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
  
  

Competencies

• To perform the job successfully, an individual should demonstrate the following
• 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
  
  

Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knowledge acquired through Education and Training:

Bachelor’s degree (4 years)

Additional Knowledge Requirement:

No required certifications.

Knowledge acquired through Work Experience:

5 up to 7 years

Experience/Traits/Skills

• 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
  
  

Language Ability:

Read and comprehend simple instructions, short correspondence and memos. Write simple correspondence. Effectively present information in one-on-one and small group situations to customers, clients and other employees.

Reasoning Ability:

Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems involving several concrete variables in standardized situations.

Computer Skills:

Microsoft Office (Word, Excel, PowerPoint, Access, Publisher, Outlook, Internet Explorer)

Specialty Software: Experience with Waters Empower or Shimadzu LabSolutions is preferred

Why Join MedPharm?

Our breadth of competencies has us partnering with clients from formula inception, clinical trials, regulatory filing and into commercial production. We are engaged in all stages of the pharmaceutical commercialization process, and you will work with some of the best clients in our industry’s CDMO space.

Diversity and Inclusion:

MedPharm is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Powered by JazzHR

6PPhJZqWbo