Career Opportunities

Research Associate

 

The Research Associate works within the Product Development team with close coordination with the Quality Team. They are responsible for review and management of outsourced analytical release, stability and investigational testing at contract development and manufacturing partners.

The position reports to the Senior Manager, Formulation and Analytical Development.

Responsibilities:

  • Manage drug testing documentation from contract development and manufacturing partners for products in development and support commercial products.
  • Author plans, reports, deviations, investigation reports, change controls, and other technical documentation.
  • Analyze data, present results; escalate issues as necessary
  • Manage raw material specifications and annual testing
  • Review and complete documentation of release and stability results
  • Manage stability study timelines and pull dates
  • Manage stability or release test analytical NCRs and investigations
  • Manage analytical method change controls
  • Manage stability and release testing databases

Required Expertise Competencies:

  • Bachelor’s degree in chemistry, a related field or other requisite experience is required.
  • Minimum 1-2 years’ experience with pharmaceutical sciences.
  • Awareness in managing relationships with vendors, contract research and contract manufacturing partners.
  • Knowledgeable in analytical testing, change management and managing deviations in a regulated environment
  • Knowledgeable in clearly presenting data and ideas.
  • Knowledgeable in technical writing skills and ability to author plans and reports.
  • Awareness in pharmaceutical regulations, standards, guidance, GXP, and quality systems.
  • Familiarity with JMP preferred

 Required Power Competencies:

  • Teamwork & Leadership: Functional influencer; builds effective partnerships and works collaboratively with others to meet shared objectives; knowledge of company structure; deliberately includes and inspires colleagues and team members.
  • Execution: Consistently directs, drives, and holds others accountable for cross-functional results; identifies ambiguity and a path forward; removes obstacles to facilitate work
  • Solution Maker: Dissects functional work/process issues to discover opportunities for improvement; leverages resources to deliver function-level solutions/improvements; begins building internal and external networks; demonstrates courage to ask questions, try new things, and provide feedback
  • Continuous Improvement:  Creates new ways for self and team to be effective; proactively leverages resources where appropriate; early adopter and implementer of technology and student of industry.
  • Awareness:  Leverages awareness and recognition of the strengths and limitations of others; resolves ambiguity and helps others reframe questions to optimize ideas and solutions

Expectations:

  • This position is hybrid with a minimum of two days per week in Burlington, MA office, between Tuesday and Thursday. Additional time in the office could be required as circumstances dictate.

Apply Here

 

EEO Statement:

scPharmaceuticals is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. It is the Company’s policy and intent to provide equal opportunity in employment, development and advancement without regard to a race, color, religious creed, sex, pregnancy, sexual orientation, gender identity, age, national origin, physical or mental disability, genetic information, ancestry, military service or veteran status, marital status or any other category protected under applicable federal, state or local law.