Job Description

 A highly reputable pharmaceutical organization is currently looking for a MS & T - Manufacturing Science and Technology Engineer - Level II to work in the greater Boston, MA. area. 

• Engineer II, Manufacturing Sciences and Technology will be involved with the successful technical transfer, process validation, and continued technical support for our manufacturing processes at Contract Manufacturing Facilities.

RESPONSIBILITIES:

• Collaborate closely with Pharmaceutical Development and Manufacturing to ensure efficient technical transfer of manufacturing processes to CMOs, technical trouble-shooting, data mining of manufacturing documentation (batch records, deviations, CAPA, etc.) to assess process performance, and continuous improvement
• Involvement across GMP production in cell banking, upstream and downstream processing, and drug product activities
• Identify requirements for laboratory studies as necessary to support process fit, process transfer decisions and scale-up, process validation, identify and implement process improvements
• Review process transfer documentation, author and review gap assessments, and technical protocols and reports.
• Provide technical support for external manufacturing processes in support of critical raw material release/product release to support supply chain
• Ensure phase-appropriate manufacturing, with an appreciation of late-stage manufacturing including process characterization and process validation activities

REQUIREMENTS:

• BS/MS in a scientific field of study, preferably an Engineering degree with 2+ years of relevant experience working in Manufacturing/Contract Manufacturing or Pharmaceutical Development
• Biologics experience required, AAV preferred
• Experienced performing continuous process monitoring, providing on-floor technical support, owned and management of change control, deviations, and CAPAs in Quality systems
• In-depth technical and regulatory understanding of GMP biologics manufacturing and supply chain, as well as applicable international regulations and standards in all phases of product development, including late-stage through commercialization
• Late stage/ commercial experience required
• Proven leadership experience and people management skills with the desire and ability to work in a fast-paced, start-up environment
• Strong collaboration and team-building, communication, and organizational skills required
• Experienced working with and managing third party contractors and vendors
• Excellent written and verbal communication skills

Company Description

Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.