Scientist-IV

Artech Information System LLC; Raritan (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading IT staffing firm seeks a Technical Operations Contractor responsible for managing the technical aspects of lifecycle management for parenteral drug products. Candidates must have a BS/BA and 3 to 5 years of experience in pharmaceutical development or manufacturing. The role includes supporting technology transfers and continuous process improvements while ensuring compliance with regulatory requirements. Strong analytical skills and the ability to work cross-functionally are essential for this critical position.

Qualifications

• 3 to 5 years’ experience in pharmaceutical development or manufacturing.
• Ability to create and maintain technical documentation.
• Experience with technical process and product performance monitoring.

Responsibilities

• Provide technical support for drug product lifecycle management.
• Support technology transfers and continuous process improvements.
• Monitor technical processes across manufacturing sites.

Skills

Pharmaceutical product knowledge

Regulatory requirements understanding

Statistical method application

Cross-functional team participation

Conflict resolution

Education

BS/BA in pharmaceutical development or related field

Job description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

• 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

Qualifications

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.

Additional Information

This is a time sensitive and critical position a quick response would be of great help.

Contact Information:

Sneha Shrivastava

Technical Recrutier

[phone]