Scientist, Performance Testing

Posted 10 Days Ago
Be an Early Applicant
Durham, NC
Mid level
Biotech • Pharmaceutical
The Role
The Scientist in Performance Testing will lead assigned studies, draft study plans, perform in vitro testing and analyze data while ensuring compliance with quality regulations. Responsibilities include training team members, maintaining laboratory equipment, and contributing to continuous process improvement initiatives.
Summary Generated by Built In

 

 

Generous PTO | Bonus Potential | 401(k) with Match | Employee Assistance Program
Core Values: Diligence, Pioneering, Integrity, Dignity 
 

Job Title: Scientist, Performance Testing
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 scientist on assigned studies. Assist with study plan writing, data analysis 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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Act as a lead scientist on assigned studies.
  • This position may be responsible for training, assisting or assigning tasks to others. May provide input to performance
  • Draft study plans and contribute to the preparation of reports for sponsors.
  • Review literature and appropriate guidances (FDA and/or EMA) in preparation for studies and to regularly update knowledge by reviewing appropriate literature.
  • Perform experiments independently in line with in vitro testing such as in vitro permeation and penetration studies, in vitro release testing studies, extractions, stability studies, etc.
  • Assist with data analysis for studies related to in vitro testing.
  • Confer with scientists, study managers, and management to conduct analyses of research projects, interpret test results, or develop nonstandard tests.
  • Cross-train and assist with research biology activities (e.g. PCR, PK/PD, etc.) as needed.
  • Report any amendments or deviations from Study Plans/SOPs to Lead Scientist and/or Study Manager, as appropriate.
  • Maintain laboratory instruments to ensure proper working order and troubleshoot malfunctions with scientists when needed.
  • Collaborates on continuous process improvement opportunities.
  • Adhere to MedPharm Standard Operating Procedures (SOPs) and guidance documents, where applicable.
  • Contribute to the preparation and review of SOPs and Forms where applicable.
  • Where applicable, promptly record all data according to Good Documentation Practices.
  • 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.
  • Ensure that all documentation, computer data, and records are stored appropriately.
  • 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
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)
No additional computer skills required.
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.
_____________________________________________________________________________________________________________________
For more information about MedPharm and our recent developments, visit MedPharm's official website at www.medpharm.com.
 

The Company
Durham, NC
230 Employees
On-site Workplace
Year Founded: 1999

What We Do

MedPharm is a world-leading contract provider of topical and transdermal product design and development services. Our delivery of robust and innovative research has commanded recognition from regulators and investors alike. We utilise our unique cost-effective performance testing models to mitigate risk and accelerate development times.

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