Sr. Scientist, Product Development

Job title: Sr. Scientist, Product Development

Company: Hikma Pharmaceuticals

Job description: Develops and/or trouble shoot standard and complex pharmaceutical dosage forms that are stable, meet bio-equivalence standards, and robust/manufacturing 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. Act as a technical resource and mentor for formulation scientists and technicians within the PD Laboratory.

Responsibilities

• Leads, develops, and/or troubleshoots standard to complex new formulations which may include potent compounds or DEA controlled substances as assigned with no supervision. Independently works within project team structure directing junior and senior scientists and technicians.
• The project scope includes those projects with the highest complexity and/or difficult IP strategy. Examples include products requiring unique or novel technology, modified, controlled, or extended release dosage forms and combination products such as nasal sprays and dry powder inhalation products. The project scope may include developmental efforts utilizing 3rd party organizations and may require international travel.
• Leads Hikma organization as a technical expert for formulation and processing techniques of multiple process trains and equipment
• Complies with laboratory and regulatory requirements, such as WI’s, SOP’s, OSHA, DEA, and cGMP’s. Leads critical review of the requirements.
• Manufactures an adequate number of developmental lots and study the correct variables to assure success. Design complex experiments to obtain required data.
• Demonstrates leadership skills in the management of projects to independently direct the execution of project milestones.
• Mentors Technicians and/or 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 PD Lab as technical resource during Registration Lot Manufacture.
• 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. Assists in review of data and QbD reports for the laboratory.
• Leads and/or participates on departmental and/or cross-functional teams as a departmental representative.
• Educates the lab on technical advances in the pharmaceutical industry. Facilitates the addition of new technology and educates the staff on the equipment
• Demonstrates the appropriate skills to successfully lead the team in accomplishment of the task.
• Facilitates the generation of the intellectual property strategy. Leads the identification and development of intellectual property opportunities for assigned projects.
• Other duties as assigned.

Qualifications

Required:

• B.S. in scientific field (pharmacy, chemistry, or engineering is preferred) with 10 years relevant pharmaceutical experience, or
• M.S. in pharmaceutics or related scientific discipline with 8 years relevant pharmaceutical experience, or
• Ph.D. (preferably in Pharmaceutics) with 5 years’ experience.
• Business & Technical Knowledge – Leverages formulation developmental and pharmaceutical equipment expertise to lead the organization in its achievement of the business goals. Anticipates industry trends and identifies potential issues to redirect team’s strategies to ensure success. Fosters an environment that encourages continuous learning and rewards strong business and technical skills. Promotes the use of best in class practices to ensure leading edge technical delivery.
• Customer Orientation – Fosters an environment in which commitment to quality and customer service is a top priority. Seeks to understand the main business drivers of current and potential customers, and tailors broad business strategies and solutions accordingly. Leads the organization to effectively respond to emerging trends in customers’ needs and expectations. Stays abreast of best practices and institutes internal standards to ensure that BI’s customer service is, and remains, unparalleled in the industry.
• Innovation & Change – Leads a culture of innovation that challenges existing paradigms and encourages expansive thinking. Examines numerous potential solutions and evaluates each against business goals and potential impact on stakeholders. Translates solutions into actionable plans that will increase productivity and support organizational strategy. Champions creative solutions that increase competitive advantage in the marketplace.
• Ability to appropriately communicate with team members, internal customers, and suppliers to complete assigned duties as appropriate for the needs of the audience. Proficient ability to facilitate effective meetings. Communication must be appropriate, timely, and accurate. Proficient ability to communicate effectively in writing, including technical documents. Proficient 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.
• Demonstrated Subject Matter Expert in experimental methodology. Ability to develop new approaches, methods or systems to analyze and collect data to support and define improved approaches to the Pharmaceutical Development Report and QbD requirements. Expert in the functionality of statistical software for experimental design.
• Expert in knowledge of pharmaceutical principles and practices. Ability to successfully formulate the most challenging dosage forms and/or processes, examples include modified/extended/ delayed release, nasal suspensions, dry powder inhalers, soft gels, hot melt, bead/pellet coated products, functional film coated, sublingual, buccal, and/or other novel delivery systems and processing techniques. Lead in novel approaches to formulation development in line with the requirements of Intellectual Property strategies. Expert knowledge of potent compound containment principles and ability to develop products designated for a potent compound facility (if required by position)
• Expert 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. The impact of critical equipment parameters on key dosage form performance parameters at the expert level is required. The required equipment knowledge base includes the majority of the following: high-shear mixers, bin blenders, tablet presses, granulators, film coaters, packaging equipment, etc. Expert knowledge of physical and chemical testing methods for pharmaceutical dosage forms.
• Expert in Intellectual Properties strategies.
• Previous Project Management experience managing and leading project and/or process improvement teams at a high level required.
• Previous experience mentoring technicians and/or junior Scientists required.
• Possess the skills and knowledge to be able to work independently with no direct supervision.

Preferred:

• Demonstrates critical thinking skills. Routinely completes complex projects. Develop systems and procedures to minimize and solve problems.
• The position requires the ability to manage multiple increasingly complex projects by influencing people and resources in a variety of functional areas throughout the company including PD, AD, DRA, Medical, QA, Operations, Warehouse, as well as external companies and vendors, while adhering to strict project timelines.
• Risk vs reward must be considered in the decision making process.
• A specific educational background and previous relevant experience are required.
• Ability to routinely make independent decisions with no direct supervisor input that are tactical in nature. Examples include definition of formulation, manufacturing processes for development of projects with the highest complexity and definition of studies and testing required to support QbD through the use of experimental design, and representation of department on cross-functional teams.
• Strategic decisions, such as adjustment of project timelines, definition of API requirements, IP strategic direction and major capital (equipment) recommendations are made by the Scientist IV with justification to the supervisor.
• Assists in defining and meeting project timelines to align with business goals. Operates within defined budgets.
• The impact of decisions for the Scientist IV are generally departmental (Product Development and/or Scientific Affairs) and routinely at the operating unit level.
• A decision on project strategy could impact filing timelines that ultimately could lead to an early or late approval by the FDA, thus impacting the launch readiness date.
• The position is not responsible for decisions regarding issues of policy and procedure, administrative matters, or personnel.
• Assesses business and scientific risk and benefits of suggested areas for innovation. Makes determination on proposed ideas for innovation based on substantial knowledge.

Notification to Agencies

Please note that Hikma does not accept unsolicited resumes or calls from third-party recruiters or employment agencies. In the absence of a signed Master Service Agreement and approval from HR to submit resumes for a specific requisition, Hikma will not consider or approve payment to any third-parties for hires made.

Expected salary:

Location: Columbus, OH

Job date: Thu, 09 Sep 2021 06:52:35 GMT


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