Biologist Process Development Manufacturing

Client Industry: Pharmaceutical
Job Title: Biologist I / II : Process Development & Manufacturing
Location: Worcester, MA 01605 – 100% Onsite
Duration: 6 Months Contract (++ possibility of extension based on performance and business needs)
Shift: 8 hours/day, 5 days/week; weekend work as necessary
Pay Rate: $25.00 to $30.00 per hour 

• Ability to work well both independently and in teams
• Strong written and oral communication skills
• Demonstrated problem-solving skills and capability to overcome complex issues
•  Must have a “results-oriented” work ethic and a positive “can-do” attitude with a strong sense of urgency and self-motivated desire to achieve
• Ability to utilize MS Excel and Word to perform tasks

Job description:

We are seeking a highly motivated Biologist I/II to join  the Manufacturing Science and Technology (MSAT) department at Bioresearch Center based in Worcester, MA. As part of the PDS&T Biologics organization, MSAT leads the process technology transfer, optimization, validation, implementation, and continuous process improvement for late-stage and commercial manufacturing of therapeutic proteins. We also provide technical support for manufacturing, GMP compliance, and regulatory filing. Our mission is to support manufacturing and drive and implement improvement of processes and technologies for commercial products to deliver  quality, compliance, financial and innovation goals for the benefit of our customers. 

Key Responsibilities Include:

• Providing technical support to late clinical stage and commercial biologics manufacturing processes
• Supporting lab scale studies relevant to late clinical stage and commercial biologics manufacturing processes
• Support the writing and data review of official documentation relevant to late clinical stage and commercial biologics manufacturing processes
• Data monitoring and trending for continuous process verification
• Applying GMP and GLP principles to all aspects of work and documentation

Education and Experience:

• BS/MS degree in a scientific or engineering discipline with 0-2 years related industry experience Knowledge, Skills and Abilities:
• Knowledge of applicable regulatory authority, compendia and ICH guidelines
• Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use
• Ability to utilize MS Excel and Word to perform tasks
• Good written and oral communication skills
• Time management and project management skills
• Problem solving and troubleshooting abilities
• Ability to work in a collaborative work environment with a team
• Strong organization skills with high attention to detail
• Aseptic handling experience desirable
• Coding experience or advanced excel capabilities desirable

Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually – These all are subject to applicable eligibility).