Manager, Product Transfer

Job Title:      Manager, Product Transfer

Location:      Cherry Hill, NJ

Job Type:     Full time

Req ID:          6132

 

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 Manager, Product Transfer to join our team.  In this role, you will be responsible for supervising the Product Transfer team at Cherry Hill leading to successful transfers and launches of new and life cycle management products.  A subject matter expert for transfer of injectable drug products.

 

Key Responsibilities:

• Lead the team 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
• Lead the team enabling technical evaluation of site capabilities, process development, registration lots manufacturing, and FDA filings.
• Enable evaluation, scale-up, process validation, launch and lifecycle management.
• Review and approve 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.
• Coordinate quality investigations, process change management, and project communications during development/ transfer/ launch/ life-cycle projects.
• Mentor the team and share best practices to continuously grow talent and enhance productivity.   

 

 

 

 

SKILLS

• Expert 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.
• Expert 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.
• 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: Expert 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 no or 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 team members, providing guidance to the Operations team regarding optimization opportunities).

 

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, Chemistry, or related scientific discipline plus a minimum of fifteen (15) years of experience in pharmaceutical product transfer, process development, technology transf