Title:  Principal Scientist, Formulation Development

Job Title:      Sr. Associate Scientist, Formulation Development - Injectables

Location:      Cherry Hill, NJ

Job Type:     Full time

Req ID:         10962

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 Sr. Associate Scientist, Formulation Development – Injectables to join our team.  

In this role, you will be responsible for leading the development aspects of the standard and specialty/highly complex injectables dosage forms within the Hikma R&D Pipeline.  Demonstrated ability to develop products that are stable, meet bioequivalence standards, and robust/manufacturable according to the defined Intellectual Property (IP) strategy. Development must be performed under the highest quality standards and under defined and condensed timelines.  Utilizes Quality by Design principles and tools to develop robust products.  Provides technical mentorship for formulation scientists and technicians within the PD Laboratory and external departments.

Key Responsibilities:

Dosage Form Development

• Independently leads, develops, and/or troubleshoots complex new formulations and processes from inception through scale-up.
• Experienced in development of differentiated/specialty injectables dosage forms including combination products. Development efforts may be undertaken within Hikma local/ global network or third party contract organizations.

• A high sense of urgency, attention to detail and results orientation is required.
• Experience in the use of QBD principles and tools (such as statistical software, in vitro/in vitro correlation techniques)

• Complies with laboratory and regulatory requirements, such as WI’s, SOP’s, OSHA, DEA, cGMP’s, FDA Developmental and Combination Product guidelines. Leads critical review of the requirements and develops strategies to address for pipeline products.

• Demonstrates leadership and critical thinking skills in the management of projects to independently direct the execution of project milestones.

Mentorship 

• Mentors formulation scientists and technicians within Product Development in drug development strategies including formulation principles/techniques, Intellectual Property, Process robustness, In vitro-in vivo correlation and Experimental design/statistical analysis.
• Serves as SME in technical aspects of pipeline and commercial products as needed within the Hikma Network.

Industry Trends and Facilitation

• Keeps abreast of current developmental trends and techniques. Serves on internal and external committees/cross-functional teams regarding formulation development.

• Researches and facilitates the addition of new technology and ideas to expand the development pipeline across the Hikma Network.

• Leads the identification and development of intellectual property opportunities for projects assigned. Assists others in formation of strategies within the product development department.

• Other duties as assigned.

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:

• Bachelor’s degree in chemistry and a minimum 10 years of relevant hands-on formulation experience; or
• Master’s degree in chemistry or other scientific discipline and 8 years of relevant hands-on formulation experience; or
• PhD in chemistry or other scientific discipline and 6 years of relevant hands-on formulation experience.
• Expansive knowledge of formulation development following QbD, materials characterization, process development, and scale up of sterile injectable products.
• Up to 20% travel may be required.
• Treats customers as partners; seeks to build long-term relationships and facilitate win-win outcomes; anticipates customer needs and supports the construction of tools, mechanisms and services to meet these; considers the impact on the various customers of any business decision; monitors customer satisfaction in a variety of ways and implements change to address identified concerns; identifies barriers to effective customer service and seeks to remove these.
• Actively promotes the development of alternative approaches when resistance and setbacks occur; encourages and motivates others towards energetic and committed performance by defining a critical path of activities; anticipates and takes action to create and opportunity or avoid future crisis, looking ahead up to 1 year; takes ownership of new initiatives or projects and follows them through; proactively develops new processes and re-engineers existing ones to improve performance.
• Is able to consider information from multiple perspectives; has the confidence to take decisions and be accountable for mistakes; takes time to consider the short and long term outcomes and actions to ensure all risks are calculated.
• Helps in reviewing policy issues, performs long-term planning, sets goals and determines priorities. Thinks beyond short-term objectives to consider the broader vision and strategic goals of Hikma.
• Gains the confidence and trust of others through honesty, integrity and authenticity; builds confidence and trust from others by sharing information to support teams to grow; takes responsibility for mishpas/mistakes and focuses on the lessons learned, encourages active learning and finding ways to frame challenges through a lens of possibility and opportunity.
• Adapts approach and demeanor in real time to match the shifting demands of different situations; Applies and adapts different models of facilitation, consulting, coaching and mentoring in a range of different situations. Ability to create and participate in an effective team across business areas, locations and cultures.
• 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 applicable laws and regulations regarding development and manufacturing of pharmaceuticals, including cGMP, DEA, FDA Guidances, ANDA Filing requirements, etc.
• Previous Project Management experience managing and leading project and/or process improvement teams at a high level required.
• Previous experience mentoring scientists and technicians in formulation and process development required.
• Possess the skills and knowledge to be able to work independently with no direct supervision.

Preferred Qualifications:

• 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.
• 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.
• Strategic decisions, such as approach to development, identification of IP strategies or additional pipeline opportunity recommendations are made 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 Principal Scientist 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.

Compensation:

Base Salary: $92,850.00 to $158,450.00 annually.  The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

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
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment.  Benefits are subject to change as well as specific plan or program terms.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions.  In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

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