About the Role Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements. Creates/Revises master manufacturing documents of assigned products (e.g. Master Batch Record, Bill of Material (BOM), and Recipe, Quality Risk Assessment, Hazard Analysis). Supports steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy. Ensures that all process changes in assigned products are managed through appropriate change control procedure. Acts as Subject Matter Expert (SME) for the product and process knowledge, be highly knowledgeable of product and process trends by providing input for analysis and driving process technology innovations. Authors manufacturing investigations and meets all targets for timely closure and CAPA completion. Supports data collection for ongoing process verification, support manufacturing lead in tracking and evaluation of product performance and implementation of CAPAs. Provides and supports assessments of technical changes, establishment of root-cause analysis, Quality Risk Assessment and process control strategies. Supports process optimization establishment and new technology introduction for continued productivity improvement. Supports the execution of process validations, and short-term improvement projects, collaborating with all the relevant parties at shop floor to ensure accurate execution. Launch and Transfer– for the product(s) assigned. ?
Minimum Requirements: B.S. degree in Engineering or the life sciences and 5 years of work experience in biopharmaceutical based GMP manufacturing operations or 3 years relevant experience in GTx. OR Masters' degree in Engineering, Biology, Chemistry, Biotechnology, or applicable field and 4 year of work experience in biopharmaceutical based GMP manufacturing operations. Experience in the development of manufacturing documentation and in the investigation of complex manufacturing deviations. In-depth knowledge of FDA regulations and GMP systems and experience providing process support in a highly regulated or pharmaceutical / biotech facility. Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products. Excellent oral and written communication skills. Strong technical writing ability required. Travel, as required, to other internal sites, vendors, and CMOs(~20%) The base pay amount at commencement of employment may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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