Sr. Scientist, Formulation Development

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