Scientist-IV

• The Technical Operations Contractor is responsible for technical aspects of the Lifecycle Management structure and strategy for parenteral drug products including SIMPONI pre-filled syringes, STELARA pre-filled syringes, and Risperdal Consta Injection.
• The candidate will provide this technical support at U.S. based contract manufacturing sites such as Baxter Bloomington, IN and Alkermes, Wilmington, OH.
• The candidate will support technology transfers, implementation of continuous process verification programs, investigations, change control initiatives, and continuous process improvement programs.

FUNCTIONAL KNOWLEDGE, SKILLS, AND ABILITIES: 

• Strong expertise with regard to pharmaceutical products & manufacturing processes with a focus on parenteral products

• Good knowledge regulatory requirements and GMP’s understands the technical aspect of the lifecycle strategy of products

• applies the science based risk approach and regulatory/GMP intelligence

• ability to create, maintain, and upgrade product technical knowledge and author documentation regarding these activities

• ability to monitor technical process and product performance across internal and external manufacturing sites and employ statistical methods to assess

• ability to participate in risk assessments with a quality and compliance perspective

PERSONAL & INTERPERSONAL SKILLS / LEADERSHIP SKILLS: 

• Ability to participate on cross functional / cross-region project teams

• Ability to manage complexity and change

• Ability to interact at different levels of the organization (including Sr. Management)

• Ability to work under pressure and resolve conflicts

• Ability to work independently under general direction, having a good sense of prioritization of assigned

tasks and manage time accordingly

• Ability to participate in a result oriented project team

PERSONAL ATTITUDE & MINDSET: 

• Can-do mentality, agility & flexibility able to work with stretched goals and deadlines

• Works with others towards the project team’s goals

• Understands culture differences

• Communicates, motivates, negotiates and is an assertive person having impact

• Shows a high sense of responsibility regarding professional activities

DEGREE REQUIREMENT: 

Minimum requirements: BS/BA with 3 to 5 years’ experience in pharmaceutical development or pharmaceutical manufacturing or related post graduate academic experience/education.

This is a time sensitive and critical position a quick response would be of great help.
Contact Information:
Sneha Shrivastava
Technical Recrutier
(973) 967 3348