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Senior Director, Product Development

Blue Ash, Ohio
General Purpose of Position:

The Senior Director of Product Development has responsibility for managing product development scientists on pre-formulation, formulation, and process development aspects of pharmaceutical dosage form development projects using Aprecia 3DP proprietary technology. The position requires pharmaceutical science expertise and substantial experience in formulation development, processing, and product commercialization across a range of dosage forms, with a core focus on solid oral dose and orally disintegrating dosage forms.  The Senior Director of Product Development will be a scientific and technical leader in the organization and will apply Aprecia 3DP technology to pharmaceutical applications.  

Primary Duties and Responsibilities (Essential Functions):
 
  Duties/Responsibilities
1 Manage product development scientists and associated R&D personnel.  Provide daily R&D personnel oversight for work assignments to ensure departmental objectives are achieved with timing that is aligned with corporate initiatives.
2 Build strategies for product formulation development that meet the needs of stakeholders, enables appropriate API handling and is in alignment with the strategic direction of Aprecia.
3 Lead cross-functional teams, provide subject matter expertise to internal development groups such as formulation development and analytical scientists, and regularly inform management of progress and outstanding issues.
4 Ensure alignment with development engineering to anticipate product formulation strategies that take full advantage of Aprecia 3DP technology.  Maintain awareness of the proper use of processing and laboratory equipment in the Blue Ash facility.
5 Analyze product development data and collaborate on key formulation and process decisions to ensure products in development can be successfully transferred to Production.
6 Ensure IP strategies are developed and executed for new formulations and manufacturing processes. When applicable, contribute toward the preparation of patent applications.
7 Perform job responsibilities in compliance with cGMP (current Good Manufacturing Practices) and all other regulatory agency requirements.
8 Support business development efforts by serving as a technical and scientific subject matter expert, establishing suitable product development options, and identifying potential formulation development challenges.
9 Prepare technical slides and supporting documentation summarizing product development studies for internal or external purposes.
10 Represent Aprecia at webinars and in-person industry events by participating and presenting on Aprecia 3DP technology.
11 Contribute to product development and regulatory initiatives through the preparation, review and approval of technical protocols and reports ensuring complete documentation for all product development activities.

Reporting to this Position:
Position will have direct reports including formulation scientists and supporting product development personnel.

Travel:
Periodic travel for business purposes may be required.

Work Shift:
This position works days on a typical business day schedule. 

Knowledge, Skills and Abilities:
  • Superior interpersonal and leadership skills required
  • Provide strategic science leadership to the Executive Leadership team
  • Ability to contribute in promotional education to clients and industry meetings
  • Strong background in pharmaceutical science, formulation, product development and 3DP and other additive manufacturing technologies
  • Superior organization and project management skills
  • Must have the ability to multi-task, manage multiple high priority items, and deliver results in a fast-paced, constantly changing environment
  • Able to establish and build partnerships across all levels of the business, operational, and R&D teams
  • Able to provide ongoing insight regarding industry trends and provide scientific expertise for corporate planning purposes
  • Strong familiarity with MS Office
Education and Experience:
  • MS/PhD in Biology, Bio Engineering, Chemistry, Chemical Engineering, Materials Science, Pharmaceutics, or related field is required
  • 15 + years in pharmaceutical product development or related areas
  • Experienced with intellectual property matters, such as patent applications
  • Prior experience managing a team and or a department is required
  • Experience with pharmaceutical education programs is preferred
Physical Demands and Work Environment:    
  • Ability to sit at a desk for extended periods of time
  • Ability to stand and walk for extended periods of time
  • Occasional lifting (5-50lbs)
  • Speaking and hearing abilities to understand and communicate with employee and external parties
  • Bending, kneeling, and other odd body positions while performing job duties on and around equipment
  • Manual dexterity to operate general office equipment and a computer for extended periods of time
  • Good eyesight to tolerate extended viewing of computer screen.  Able to read, interpret, and create business documents and communications


GENERAL INFORMATION:
The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies.  The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position.  It is not intended to be an exhaustive list of all duties, responsibilities, and skills required.  The position may require other duties as assigned and can be changed at any time by the company.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

 

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