Scalence L.L.C. · 18 hours ago
Senior Process Engineer
Boston, MA
Full-time
Onsite
Mid, Senior Level
$88/hr - $92.85/hr
3+ years expScalence L.L.C. is a company that focuses on biologic drug substance technology transfers. The Senior Process Engineer will support these transfers across Alexion’s biologics pipeline while ensuring GMP-compliant manufacture and driving process readiness.
Information Technology & Services
Responsibilities
Support continuous improvement of efficiency of technology transfer processes through development of standard operating procedures, job aids, & supplemental reference/training materials and with alignment to ongoing digitalization initiatives
Serve as technical SME for routine activities for biologics tech transfer & GMP manufacture and validation including but not limited to creation/review of technical protocols or reports, manufacturing records, & quality records, sample plan coordination, and monitor & trend manufacturing batch performance
Support compilation of data for regulatory source documents & perform technical review of IND/IMPD, BLA/MAA for regulatory submissions
Work in partnership with Biologics Drug Substance leadership and SMEs to lead the development and implementation of robust raw material control strategy, inclusive of raw material assessments and justification of specifications
Qualification
Required
A degree in related Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Biochemical, Mechanical) field. A PhD, a MS with at least 6 years of relevant experience, or a BS with at least 8 years of relevant experience
Experience and in-depth technical, and operational knowledge of multiple drug substance unit operations including cell culture, centrifugation, filtration, UF/DF, and chromatography
Comprehensive understanding clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure manufacturing operations are GMP compliant
This role is primarily office based, with requirement for routine on-site presence at the designated Alexion office. Ability to travel domestically up to two weeks (total on average ~25%) at a time for manufacturing site support
During travel for manufacturing support, this role requires physical capabilities to gown and de-gown PPE in GMP cleanroom environment and be present during manufacturing operations in a technical support role. Physical elements include standing, climbing stairs, ladders, visual capability to read manufacturing control screens, use a computer, engage in communications via phone, video, and electronic messaging
Ability to drive for results independently and adapt to rapidly changing priorities
Effective problem solving and technical decision-making skills in a manufacturing environment
Strong oral and written communication skills and attention to detail; ability to present and defend technical and scientific approaches and decisions in both written and verbal form to internal and external partners
Excellent collaboration skills, with ability to participate in global cross-functional teams and work effectively in a highly matrix team environment
Preferred
Prior experience in establishing and defending raw material control strategy and associated raw material specifications with regulatory agencies
Proven track record of supporting or leading continuous improvement initiatives
Knowledge and use of basic statistical analysis methods
Ability to influence others without direct authority and communicate with all levels of the organization
Company
Scalence L.L.C.
In today’s dynamic and competitive market, success hinges on mastering three key areas: Data Intelligence, Business Resilience, and Digital Experience.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase