Title:  Principal Scientist, Product Development/Transfer

Job Title:      Principal Scientist, Product Development/Transfer

Location:      Cherry Hill, NJ or Bedford, OH

Job Type:     Full time

Req ID:          6039

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 750 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 8,500+ 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 Principal Scientist, Product Development/Transfer to join our team.  In this role, you will be responsible as a formulation project lead for business development projects and third-party projects leading to regulatory submissions, approvals and launches for injectable products.

You will work with cross functional teams and provide technical support to product transfers team enabling successful transfers leading to submissions and launches for Hikma or third party developed products and life cycle management products as well as provide technical support for efforts to mitigate and resolve open investigations and process remediations.

You will service as a subject matter expert to develop a path to implement new regulatory guidance, address process development challenges in relation to injectable products and queries from regulatory authorities and regulatory site inspections.

Key Responsibilities:

• Formulation lead for third party development projects performing due diligence and enabling timely submission, approvals and launches.
• Work with cross functional teams and provide strategies for successful scale up process development and remediations.
• Draft/ Review/ Approve technical documents.
• Support regulatory filings by drafting technical documents for submission and responses to queries leading to timely approvals and launches.
• Draft/ review commercial process redevelopment experimental plans to address and mitigate process development challenges and process remediations.
• Be current on regulatory guidance and work with cross functional teams to develop a path to implement new regulatory guidance.
• Provide updates to senior management.

Skills:

• Good people skills.
• Thorough understanding and proficient in Injectables product development.
• In-depth knowledge on current industry practices and guidance.
• Extensive experience in pharmaceutical formulation development and filing with USFDA.
• Good communication skills, both oral and written.

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 or pharmaceutical science or closely related field and at least 12 years of pharmaceutical drug development experience in R&D with a focus on injectable drug products.
• Master’s degree in chemistry or pharmaceutical science or closely related field and at least 8 years of pharmaceutical drug development experience in R&D with a focus on injectable drug products.
• Ph.D. in chemistry or pharmaceutical science or closely related field and at least 5 years of pharmaceutical Drug Development experience in R&D with focus on Injectable Drug 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 3% 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.

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.

Agency Notice:

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.