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Scientist, Formulation Development

Job Title: Scientist, Formulation Development

Location: Columbus, OH

Job Type: Full time

About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day. for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Scientist, Formulation Development to join our team. In this role, you will be responsible for primarily developing standard and complex pharmaceutical nasal formulation products and possibility other 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.

Key Responsibilities:

• Regular and predictable onsite attendance and punctuality.
• Works within project team structure with minimal supervision to develop new formulations for standard and complex developing nasal and/or inhalation pharmaceutical products forms which may include potent compounds or DEA controlled substances as assigned.
• The project scope includes projects of moderate complexity such as developing nasal and/or inhalation pharmaceutical products dosage forms of BCS (Biopharmaceutical Classification System) Class 2 and 4 compounds, suspensions, modified, controlled, or extended release products, and/or basic IP strategy.
• Continues to increase pharmaceutical development expertise by assisting senior Scientists in development of dosage forms through hands on experiences and formal training.
• Demonstrates knowledge of formulation and processing techniques of 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.
• Complies with laboratory and regulatory requirements, such as WI's, SOP's, OSHA, DEA, and cGMP's and demonstrates the ability to critically review the requirements.
• Manufacture an adequate amount of developmental lots and study the correct variables to assure success.
• Design moderately complex experiments to obtain required data.
• Demonstrate effective project management skills to facilitate the execution of project milestones.
• Plans, observes, and coordinates the manufacture, packaging, and disposition of the Pilot and Registration Lots.
• Assists and consults during scale-up and validation activities.
• Supports assigned projects throughout the lifecycle of the product as the demonstrated 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.
• Successfully interacts within the department to accomplish project and departmental goals.
• 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.
• Leverages comprehensive knowledge of the formulation development process, processing equipment, regulatory policies and general practices in making decisions and recommendations.
• Applies a comprehensive understanding of concepts within Product Development to develop relatively advanced programs/processes.
• Serves as an expert within Product Development on a limited scope of equipment; educates others on technical issues.
• Develops positive internal and external customer relationships by consistently and efficiently delivering value.
• Clearly communicates performance expectations and objectives to others to ensure understanding and buy-in.
• Aids others in understanding the steps and resources necessary to achieve and surpass desired results.
• Takes action to implement and correct plans to ensure goals are met within reasonable or defined timelines.
• Anticipates potential barriers to achieving team objectives and collaborates with others to develop strategies for success.
• Ability to appropriately communicate with team members and internal customers 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.
• Demonstrated ability to communicate effectively in writing, including technical documents.
• Demonstrated ability to generate and deliver formal technical presentations to team members and internal customers.
• Proficient 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.
• Working knowledge of experimental methodology and design of experiments to support the Pharmaceutical Development Report and QbD requirements.
• Ability to define root-cause relationships, collect data, establish facts and draw valid conclusions.
• Familiar with statistical software for experimental design.
• Working knowledge of pharmaceutical principles and practices.
• Ability to incorporate approaches in line with the requirements of Intellectual Property strategies.
• Demonstrate a basic knowledge of potent compound containment principles and ability to develop products designated for a potent compound facility (if required by position).
• Proficient knowledge of applicable laws and regulations regarding development and manufacturing of pharmaceuticals, including cGMP, DEA, FDA Guidances, ANDA Filing requirements, etc.
• Demonstrates strong mechanical and technical aptitude with the ability to set-up, run and troubleshoot pharmaceutical manufacturing equipment.
• Knowledge of physical and chemical testing methods for pharmaceutical dosage forms, preferably nasal and/or inhalation products.
• Working understanding of Intellectual Property Strategy.
• Has the ability to facilitate the execution of project milestones through the use of project management skills.
• Possess the skills and knowledge to be able to work independently with minimal supervision.
• Knowledge of potent compound containment principles and ability to develop products designated for a potent compound facility (if required by position).
• Must be able to identify root cause relationships.
• Demonstrate ability to develop more technically challenging projects.
• The position requires the ability to manage multiple moderately complex projects by influencing people and resources in a variety of functional areas throughout the company, including PD, AD, DRA, Medical, QA, Operations, Warehouse, while adhering to strict project timelines.

Qualifications:

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• B.S. in scientific field (pharmacy, chemistry, or engineering is preferred) with 3+ years relevant experience.
• or M.S. in pharmaceutics or related scientific discipline with 1+year relevant experience (preferably in Pharmaceutics).
• Preferred Qualifications:
• Prior experience developing and filing multiple ANDA's.
• Prior experience with developing nasal and/or inhalation pharmaceutical products.

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay.
• Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays