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Title:  Sr. Scientist, Formulation Development - 3473

Description: 

 

 

Develop and/or trouble shoot standard and complex pharmaceutical solid (tablet/capsule) and oral liquid dosage forms that are stable, bioequivalent to the brand product, and robust/manufacturable according to the defined Intellectual Property (IP) strategy.  Complete Registration Lot manufacture and provide documentation in support of QbD (Quality by Design) principles for the Regulatory Filings.

 

Responsibilities

 

  • Regular and predictable onsite attendance and punctuality.
  • Works within project team structure with minimal to no direct supervision to develop and/or trouble shoot standard to complex new formulations for oral solid and liquid dosage forms, which may include potent compounds or DEA controlled substances as assigned.
  • The project scope includes those of increasing complexity, such as immediate release solid dosage forms of BCS (Biopharmaceutical Classification System) Class 2 and 4, suspensions, modified, controlled, or extended release products, powders for oral suspension, nasal suspensions, and/or moderately difficult IP strategy.
  • The project scope may include developmental efforts utilizing 3rd party organizations and may require international travel.
  • Departmental technical resource for formulation and processing techniques of multiple process trains and equipment.
  • To develop robust, stable, and bioequivalent dosage forms for regulatory filing and launch.
  • Generates, collects and reviews data on developmental lots to determine the most optimal formulation and manufacturing process in support of QbD requirements with respect to stability, bioequivalency, robustness and IP strategy.
  • Manufacture an adequate number of developmental lots and study the correct variables to assure success.  Design complex experiments to obtain required data. 
  • Complies with laboratory and regulatory requirements, such as WI’s, SOP’s, OSHA, DEA, and cGMP’s and influences critical review of the requirements.
  • Manufacture an adequate number of developmental lots and study the correct variables to assure success.  Design complex experiments to obtain required data. 
  • Utilize project management skills to influence and direct the execution of project milestones.
  • Mentors Technicians and/or junior Scientists to assist in attainment of objectives as assigned.
  • Plans, observes, and coordinates the manufacture, packaging, and disposition of the Pilot and Registration Lots. 
  • Assists, consults, and trouble-shoots during scale-up and validation activities. Supports assigned projects throughout the lifecycle of the product as the Subject Matter Expert (SME).
  • Generate and/or review the required documentation to justify the formulation and process selected. 
  • Obtain the required samples and perform the attendant testing. 
  • Record personal observations and provide consultation during the manufacturing and packaging of the Registration, Scale-Up and/or Validation Lots.
  • Reviews and collects data on Pilot and Registration Lots. 
  • Incorporates the data in the required Technical Reports, including the Pharmaceutical Development Report in support of QbD for the regulatory filings. 
  • Provide technical input for FDA CMC and DBE deficiencies as required.
  • Conducts the proper experiments and collects the appropriate data to justify the product specification and support the approval of the product via the QbR/QbD documentation and required regulatory filings.
  • Leads strategic teams within the department and participate on cross-functional teams.
  • Successfully interacts within and outside the department to accomplish project, departmental and corporate goals.
  • Demonstrates the appropriate skills to successfully influence the team to accomplish the task. 
  • Participates in the generation of the intellectual property strategy.  Identifies opportunities and participates in the development of intellectual property for assigned projects. 
  • Reviews appropriate patents, literature, and prior art for applicability to assigned projects.  Utilizes the Record of Invention form for documentation of the prospective intellectual property.

 

Qualifications

 

  • B.S. in scientific field (pharmacy, chemistry, or engineering is preferred) with 6 years relevant pharmaceutical experience, or
  • M.S. in pharmaceutics or related scientific discipline with 4 years relevant pharmaceutical experience, or
  • Ph.D. (preferably in Pharmaceutics) with 1-year experience
  • Understands factors that drive Product Development’s performance and prioritizes issues accordingly
  • Applies expert knowledge of the formulation development process, processing equipment, regulatory policies and general practices in making decisions
  • Employs expert knowledge in Product Development and a broad understand of related disciplines to create advanced programs/processes that have broad application outside of the department. 
  • Shares expert knowledge of complex technical concepts and guides the design of policies/programs
  • Maintains ongoing relationships with multiple customer constituencies as a trusted advisor
  • Solicits feedback on customer satisfaction from multiple sources and incorporates data into action plans
  • Examines customers’ business strategies to identify opportunities to provide more efficient, higher quality products and/or services
  • Draws on customer insight and benchmark practices to advise others on how to best meet customers’ current and future needs
  • Coaches others on taking accountability for accomplishing objectives
  • Ensures others understand how the objectives of a task or project relate to overall organization goals
  • Develops and uses tools to assess ongoing performance, measure results, and encourage superior achievement
  • Develops strategies and guides others to overcome obstacles to avoid detrimental impact on results
  • Ability to appropriately communicate with team members, internal customers, and suppliers to complete assigned duties as appropriate for the needs of the audience
  • Demonstrated ability to facilitate effective meetings
  • Communication must be appropriate, timely, and accurate
  • Ability to communicate effectively in writing, including technical documents
  • Ability to generate and deliver formal technical presentations to team members and internal/external customers
  • Expert computer skills with the ability to enter data into and retrieve information from various software programs such as Microsoft Office Suite programs Word, Excel, PowerPoint, and Outlook
  • Extensive knowledge of experimental methodology
  • Ability to design complex experiments to obtain the required data in support of the Pharmaceutical Development Report and QbD requirements
  • Mastery of pharmaceutical principles and practices
  • Ability to successfully formulate the challenging dosage forms and/or processes, examples include modified/extended/ delayed release, nasal suspensions, soft gels, bead/pellet coated products, film coated products, sublingual, buccal, and/or other novel delivery systems and processing techniques
  • Incorporate formulation or processing approaches in line with the requirements of Intellectual Property strategies
  • Demonstrates strong mechanical and technical aptitude with the ability to set-up, run and troubleshoot pharmaceutical manufacturing equipment
  • The impact of critical equipment parameters on key dosage form performance parameters at the expert level is required

 

What We Offer

 

  • Annual performance bonus potential
  • 401k employer match up to 6% of your contributions
  • 23 vacation/personal days
  • 11 paid Company holidays
  • Generous healthcare benefits
  • Employee discount program
  • Wellbeing rewards programs
  • Safety and Quality is a top organizational priority
  • Career advancement/growth opportunities
  • Tuition Reimbursement
  • Maternity and Parental Leave

 

*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms.

Location: 

Columbus, OH, US, 43228


Nearest Major Market: Columbus

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