Senior Director of Product Development and Engineering

The Senior Director/Vice President of Product Development and Engineering is the senior leader for the Product Development for scPharmaceuticals, Inc. This individual is responsible for both pharmaceutical and device development, as well as pharmaceutical technical operations. The position reports to the SVP of Technical Operations.

Responsibilities:

  • Manage the technical development of pharmaceutical products through relationships with outsourced development laboratories
  • Interpret input from consultant resources and development laboratories to provide technical decisions and direction for the team
  • Provide subject matter expertise for drug development during new product introductions; work closely with project management and regulatory for technical documentation and content in regulatory submissions.
  • Manage the development/customization of drug delivery devices through relationships with contract development and manufacturing partners
  • Establish relationships and partnerships with outside CMOs as needed for development and manufacturing activities
  • Create and manage budgets for developmental and pharmaceutical tech ops activities
  • Author reports that include technical input from the CMO and Development laboratory partners
  • Devise strategies for drug delivery technology based upon established or developing device technology
  • Perform/outsource technology assessments for future potential business opportunities supporting company business development initiatives
  • Partner with Medical Affairs, Clinical Affairs and Marketing to define Target Product Profiles and User Requirements for new products
  • Supervise Product Development and Pharmaceutical Technical Operations teams
  • Work closely with Regulatory, Quality and Operations teams to ensure local procedures and their execution are consistent with regulatory compliance standards and company quality objectives

Qualifications:

  • Minimum of 15 years’ experience in a pharmaceutical development and manufacturing environment and at least 10 years’ experience in a leadership position such as Product Development Manager/Director
  • Strong background in parenteral pharmaceutical management from product development through manufacturing preferred
  • Technical competence in formulation development, analytical methods, and pharmaceutical manufacturing technologies.
  • Exposure to drug delivery device development and manufacturing technology is a plus
  • BS in Chemistry or Chemical Engineering, Master’s or PhD a plus (or similar degree with comparable experience)
  • Assertive with appropriate humility, strong leadership and communication skills
  • Able to focus and effectively work under time restrictions
  • Ability to travel domestically and internationally up to twenty percent per month

 Skills and Abilities:

  •  You are self-directed and able to work at all levels of the organization with a “hands on” management style to accomplish goals
  • You thrive in small company environments and know how to maximize resources. You understand, appreciate, and desire to work in a growing organization
  • You have an entrepreneurial mindset and approach to business challenges
  • You act with impeccable integrity and treat your colleagues and business partners with the utmost respect
  • You understand strategy, transition to execution, and effectively lead teams and/or peers through this process
  • You strive for excellence and expect the same from your team and colleagues
  • You have strong collaboration skills capable of influencing internal and external decision-makers
  • You provide strong leadership, people management, influencing and motivating skills
  • You possess strong communication skills
  • You provide strong thought leadership and strategic thinking skills with a demonstrated ability to identify business issues and opportunities

 EEO Statement

scPharmaceuticals is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.