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Hikma Pharmaceuticals · 1 day ago

Scientist, Formulation Development

Columbus, OH

Full-time

Onsite

Mid Level

3+ years exp

Hikma Pharmaceuticals is a developer, manufacturer, and supplier of essential medicines, committed to bringing Better Health. Within Reach. Every Day.® for millions of patients. They are seeking a talented and motivated Scientist, Formulation Development to develop pharmaceutical nasal formulations and ensure compliance with regulatory requirements.

HealthcarePharmaceuticalHealth CareMedical

H1B Sponsor Likely

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

With minimal supervisor input; examples include definition of formulation and manufacturing processes for development of moderately complex projects and execution of QbD studies as directed by the supervisor

Completes projects within project milestone timelines

Qualification

Pharmaceutical formulation developmentQuality by Design (QbD)Regulatory filing experienceExperimental design methodologyCGMP regulationsProject management skillsMechanical aptitudeCustomer relationship managementCommunication skillsTechnical writingTeam collaborationProblem-solving skills

Required

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)

Regular and predictable onsite attendance and punctuality

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

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