BioSpace
Manufacturing Bioprocess MFG Lead (Downstream)
BioSpace, Baltimore, Maryland, United States, 21276
Job Overview
Manufacturing Bioprocess MFG Lead (Downstream) Location: Baltimore, MD • Compensation: $160,000 - $220,000 Seniority level: Mid-Senior level • Employment type: Full-time Company: Syngene International Ltd. Posting context: This role is a shift production lead responsible for downstream GMP manufacturing activities and will manage a team of manufacturing associates and leads. The candidate will support 24/7 operations as needed and participate in safety, compliance, and continuous improvement initiatives. Job Summary
The Assistant Manager (Manufacturing Lead Associate) is a shift production lead in downstream GMP production activities. Responsibilities include day-to-day operations in downstream processes (e.g., chromatography, TFF, filtration), media/buffer preparation, single-use system assembly, glasswash, autoclave support, and related manufacturing steps. This role ensures safe, compliant, and efficient execution of drug substance manufacturing processes and directly manages a team of manufacturing associates and leads. Primary Responsibilities
Team Support & Oversight: Provide direction to junior staff during batch execution; coordinate shift activities and lead daily Tier huddles; escalate issues to management as needed. Technology Transfer & SME: Support SOP and MBR drafting; become SME on new equipment introduced during process changes or site expansions. Manufacturing Operations/Compliance: Perform complex downstream operations (e.g., chromatography, TFF); assemble production systems; operate glasswash/autoclave for sterile components; monitor real-time process parameters and escalate deviations; execute Master Batch Records (MBR) under cGMP and document per SOPs and MBRs; ensure adherence to cGMP, FDA/EMA regulatory requirements, and internal SOPs; lead deviation investigations, root cause analyses, and CAPA implementation; promote data integrity and robust documentation; ensure batch record, logbook, and cleaning documentation accuracy; support 24/7 operations including off-shift or weekend coverage. Process Introduction & Technology Transfer: Serve as the manufacturing lead for new product introductions (NPI); collaborate with MSAT and Process Development; ensure facility and equipment readiness, documentation preparations (SOPs and Master Batch Records), and personnel training for new processes; support PPQ batches and readiness for commercial launch. Continuous Improvement & Operational Excellence: Establish 5S and area ownership; propose and implement process improvements; maintain 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. Proficient with single-use bioreactor systems and media preparation techniques. Proficient 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 expectations include on-the-floor presence of approximately 75% of the time. Physical/mental demands typical of essential manufacturing roles; considerations for safety and quality assurance; accommodations may be provided for qualified individuals with disabilities. Work environment may involve extreme temperatures, high noise levels, restricted access, and exposure to dust, gas, fumes, steam, or chemicals. May require approximately 5% to 10% travel, including potential international travel based on business needs. Equal Opportunity Employer
Syngene is an equal employment opportunity (EEO) employer. We prohibit discrimination based on 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. Reasonable accommodations will be provided for qualified individuals with disabilities.
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Manufacturing Bioprocess MFG Lead (Downstream) Location: Baltimore, MD • Compensation: $160,000 - $220,000 Seniority level: Mid-Senior level • Employment type: Full-time Company: Syngene International Ltd. Posting context: This role is a shift production lead responsible for downstream GMP manufacturing activities and will manage a team of manufacturing associates and leads. The candidate will support 24/7 operations as needed and participate in safety, compliance, and continuous improvement initiatives. Job Summary
The Assistant Manager (Manufacturing Lead Associate) is a shift production lead in downstream GMP production activities. Responsibilities include day-to-day operations in downstream processes (e.g., chromatography, TFF, filtration), media/buffer preparation, single-use system assembly, glasswash, autoclave support, and related manufacturing steps. This role ensures safe, compliant, and efficient execution of drug substance manufacturing processes and directly manages a team of manufacturing associates and leads. Primary Responsibilities
Team Support & Oversight: Provide direction to junior staff during batch execution; coordinate shift activities and lead daily Tier huddles; escalate issues to management as needed. Technology Transfer & SME: Support SOP and MBR drafting; become SME on new equipment introduced during process changes or site expansions. Manufacturing Operations/Compliance: Perform complex downstream operations (e.g., chromatography, TFF); assemble production systems; operate glasswash/autoclave for sterile components; monitor real-time process parameters and escalate deviations; execute Master Batch Records (MBR) under cGMP and document per SOPs and MBRs; ensure adherence to cGMP, FDA/EMA regulatory requirements, and internal SOPs; lead deviation investigations, root cause analyses, and CAPA implementation; promote data integrity and robust documentation; ensure batch record, logbook, and cleaning documentation accuracy; support 24/7 operations including off-shift or weekend coverage. Process Introduction & Technology Transfer: Serve as the manufacturing lead for new product introductions (NPI); collaborate with MSAT and Process Development; ensure facility and equipment readiness, documentation preparations (SOPs and Master Batch Records), and personnel training for new processes; support PPQ batches and readiness for commercial launch. Continuous Improvement & Operational Excellence: Establish 5S and area ownership; propose and implement process improvements; maintain 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. Proficient with single-use bioreactor systems and media preparation techniques. Proficient 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 expectations include on-the-floor presence of approximately 75% of the time. Physical/mental demands typical of essential manufacturing roles; considerations for safety and quality assurance; accommodations may be provided for qualified individuals with disabilities. Work environment may involve extreme temperatures, high noise levels, restricted access, and exposure to dust, gas, fumes, steam, or chemicals. May require approximately 5% to 10% travel, including potential international travel based on business needs. Equal Opportunity Employer
Syngene is an equal employment opportunity (EEO) employer. We prohibit discrimination based on 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. Reasonable accommodations will be provided for qualified individuals with disabilities.
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