Syngene
Manufacturing Bioprocess MFG Lead (Upstream)
Syngene, Baltimore, Maryland, United States, 21276
Overview
Manufacturing Bioprocess MFG Lead (Upstream) – Baltimore, MD, US. The role leads upstream GMP production activities, directly manages a team of manufacturing associates and leads, and ensures safe, compliant, and efficient execution of drug substance manufacturing processes. Responsibilities
Team Support & Oversight: Provide direction to junior staff during batch execution. Support technology transfer: Assist with SOP and MBR drafting. Subject Matter Expert (SME): Become SME on new equipment introduced during process changes or site expansions. Manufacturing Scheduling: Coordinate the execution of the manufacturing schedule through daily shift assignments and lead daily Tier huddles. Escalation: Ensure appropriate escalation to management. Manufacturing Operations/Compliance: Perform complex upstream operations (bioreactor runs, chromatography, TFF); assemble production systems; manage glasswash and autoclave functions; monitor real-time parameters and escalate deviations. Documentation & Compliance: Execute Master Batch Records (MBR) under cGMP; maintain detailed SOPs/MBRs; ensure cGMP and regulatory compliance (FDA/EMA); lead deviation investigations and CAPAs; uphold data integrity and robust documentation practices; manage batch records, logbooks, and cleaning documentation. Quality & Improvements: Lead or contribute to deviation investigations, CAPA development, and quality documentation; support 24/7 operations as needed, including off-shift or weekend coverage. Process Introduction & Technology Transfer: Lead manufacturing for new product introductions (NPI); collaborate with MSAT and Process Development; ensure facility readiness and documentation; train personnel for new processes. Process Validation & Launch: Support PPQ batches and readiness for commercial launch. Continuous Improvement: Establish 5S and Area ownership; propose and implement process improvements; adhere to Leader Standard Work. Education & Qualifications
Associate or Bachelor’s Degree in Life Sciences, Biotechnology, or Engineering preferred. 4+ years in biologics manufacturing in either upstream or downstream. Proficiency with single-use bioreactor systems and media preparation techniques. Proficiency with filtration and large-scale chromatography processes. Strong knowledge of cGMP, SOPs, and cleanroom operations. Experience with new facility startup, equipment commissioning/qualification. Deep understanding of upstream (cell culture/fermentation) and downstream (purification) unit operations for biologics manufacturing. Prior experience supporting client-sponsored manufacturing or operating in a CDMO environment. Additional Requirements
Site-based role may require a fluid schedule to support a 24/7 operation, including weekends, nights, and holidays. Schedule changes may occur based on business needs. Routine production requires presence on the manufacturing floor at least 75% of the time. The work environment may involve extreme temperatures, high noise levels, restricted laboratory access, and exposure to dust, gas, fumes, steam, or chemicals. The role may require travel up to 5–10% and may include international travel based on business needs. Reasonable accommodations may be provided for qualified individuals with disabilities. Equal Opportunity Employer
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable law. Syngene will provide reasonable accommodations for qualified individuals with disabilities. Nearest Major Market:
Baltimore
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Manufacturing Bioprocess MFG Lead (Upstream) – Baltimore, MD, US. The role leads upstream GMP production activities, directly manages a team of manufacturing associates and leads, and ensures safe, compliant, and efficient execution of drug substance manufacturing processes. Responsibilities
Team Support & Oversight: Provide direction to junior staff during batch execution. Support technology transfer: Assist with SOP and MBR drafting. Subject Matter Expert (SME): Become SME on new equipment introduced during process changes or site expansions. Manufacturing Scheduling: Coordinate the execution of the manufacturing schedule through daily shift assignments and lead daily Tier huddles. Escalation: Ensure appropriate escalation to management. Manufacturing Operations/Compliance: Perform complex upstream operations (bioreactor runs, chromatography, TFF); assemble production systems; manage glasswash and autoclave functions; monitor real-time parameters and escalate deviations. Documentation & Compliance: Execute Master Batch Records (MBR) under cGMP; maintain detailed SOPs/MBRs; ensure cGMP and regulatory compliance (FDA/EMA); lead deviation investigations and CAPAs; uphold data integrity and robust documentation practices; manage batch records, logbooks, and cleaning documentation. Quality & Improvements: Lead or contribute to deviation investigations, CAPA development, and quality documentation; support 24/7 operations as needed, including off-shift or weekend coverage. Process Introduction & Technology Transfer: Lead manufacturing for new product introductions (NPI); collaborate with MSAT and Process Development; ensure facility readiness and documentation; train personnel for new processes. Process Validation & Launch: Support PPQ batches and readiness for commercial launch. Continuous Improvement: Establish 5S and Area ownership; propose and implement process improvements; adhere to Leader Standard Work. Education & Qualifications
Associate or Bachelor’s Degree in Life Sciences, Biotechnology, or Engineering preferred. 4+ years in biologics manufacturing in either upstream or downstream. Proficiency with single-use bioreactor systems and media preparation techniques. Proficiency with filtration and large-scale chromatography processes. Strong knowledge of cGMP, SOPs, and cleanroom operations. Experience with new facility startup, equipment commissioning/qualification. Deep understanding of upstream (cell culture/fermentation) and downstream (purification) unit operations for biologics manufacturing. Prior experience supporting client-sponsored manufacturing or operating in a CDMO environment. Additional Requirements
Site-based role may require a fluid schedule to support a 24/7 operation, including weekends, nights, and holidays. Schedule changes may occur based on business needs. Routine production requires presence on the manufacturing floor at least 75% of the time. The work environment may involve extreme temperatures, high noise levels, restricted laboratory access, and exposure to dust, gas, fumes, steam, or chemicals. The role may require travel up to 5–10% and may include international travel based on business needs. Reasonable accommodations may be provided for qualified individuals with disabilities. Equal Opportunity Employer
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable law. Syngene will provide reasonable accommodations for qualified individuals with disabilities. Nearest Major Market:
Baltimore
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