Title:  Scientist

Title: Scientist

Job Title: Scientist, Validation

Reports to: Manager, Product Transfer

Location: Cherry Hill, NJ

Job Type: Full time

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 II, Technical Affairs, to join our team.  In this role, you will be responsible for leading projects at Cherry Hill enabling successful transfers and launches of new and life cycle management of injectable drug products.

Key Responsibilities:

1. Onsite, predictable attendance
2. Lead the project enabling the transfer of products of varying types from R&D, another Hikma facility or CMO to Commercial Operations as a Process Champion from Hikma.
3. Performs technical evaluation of site capabilities, process development, registration lots manufacturing, and FDA filings.
4. Monitoring and evaluation, scale-up, process validation, launch and lifecycle management.
5. Author and review documentation (e.g. master batch records, protocols/ reports, technical justifications for matrix approach etc.) for scale-up, evaluation, and validation batch production, based on development process design parameters, scale-up considerations, and best practices.
6. Coordinate quality investigations, process change management, and project communications during development/ transfer/ launch/ life-cycle projects.

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:

 EDUCATION

Minimum:  A specific educational background and previous relevant experience are required.

• B.S. degree in Engineering, Pharmaceutical Sciences, Chemistry, or related scientific discipline plus a minimum of 1-2 year of experience in pharmaceutical product transfer, process development, technology transfer and validation, and/or process engineering for injectable products in a GMP environment.
•   SKILLS

• Implementation knowledge of applicable guidance and regulations regarding development and manufacturing of injectable pharmaceuticals, including FDA, cGMP, DEA, OSHA and other applicable regulatory and company guidelines.
• Knowledge of injectable pharmaceutical formulation development, processing equipment, quality by design, and cGMP production with emphasis on scale-up/ optimization and validation.
• Demonstrated ability to develop, scale-up, and/or validate injectable pharmaceutical processes for unique and challenging dosage forms; Demonstrate strong learning agility towards process technologies that are outside of previous experience.
• Attention to detail to documentation to ensure quality and accuracy.
• Excellent written and oral communication skills.
• Excellent people skills
• Knowledge of injectable pharmaceutical formulation development, processing equipment, quality by design, and cGMP production with emphasis on scale-up/ optimization and validation.
• Experience in injectable pharmaceutical industry in a GMP environment.
• Conflict Management: Demonstrated ability to work with professionals/ teams with differing perspectives from external/ contract organizations from different regions (domestic and international) and achieve mutually acceptable solutions.
• Experimental Methodology: Demonstrated ability to design complex experiments to support pharmaceutical development/process transfer/validation. 
• Complex Problem Solving: Knowledge of and ability to apply investigative techniques to uncover problem areas, determine root causes, and drive corrective actions at both the individual and cross-functional team level. 
• Situational leadership: Demonstrated ability to independently work with minimal supervision to make strategic decisions and execute tactical tasks of high complexity. 
• Teamwork: Demonstrated ability to be an influencing participant on teams of high complexity, and to lead/facilitate teams on tasks of high complexity.
• Mentoring: Demonstrated ability to mentor and/ or train both in and out of department structures (e.g. mentoring junior team members, providing guidance to the Operations team regarding optimization opportunities).

Location:  

Cherry Hill, NJ, US, 08003