Downstream Manufacturing Supervisor

Downstream Manufacturing Supervisor Bionova Scientific LLC is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. We bring together top scientific talent, equip them with the best tools, and operate in an agile, energized culture focused on solving challenging client problems. As an Asahi Kasei subsidiary since May 2022, we have accelerated growth and expanded service offerings. Position Summary The Manufacturing Supervisor – Downstream will lead and supervise day-to-day operations in GMP manufacturing suites, focusing on downstream processes. The role manages shift activities, ensures cGMP compliance, drives timelines, coaches the team, and supports regulatory compliance and client deliverables. Essential Duties and Responsibilities Supervise and oversee complex downstream unit operations, including chromatography, TFF, depth filtration, virus filtration, and buffer preparation in GMP suites. Ensure manufacturing goals, batch milestones, and project deadlines are met while maintaining full cGMP compliance. Lead shift transitions by being present during handovers, ensuring clear communication with both outgoing and incoming teams. Provide strong people leadership with a focus on engagement, coaching, performance management, accountability, and maintaining a positive, collaborative work environment. Oversee training and ensure team members complete all required qualifications; maintain personal compliance with downstream GMP training requirements. Support troubleshooting of equipment and processes; oversee pilot-scale and non-GMP tox material generation, as well as GMP downstream manufacturing activities. Review and approve technical documents, including production batch records, SOPs, training materials, tech transfer documentation, and regulatory filings. Ensure accurate documentation of all activities in compliance with cGMP and cGDP standards. Maintain cleanroom practices and housekeeping per established SOPs. Identify issues or non-conformities, assess impact on product quality and timelines, and elevate to management as appropriate. Support investigations, deviations, CAPA, change controls, and area walk-throughs; contribute to continuous improvement initiatives. Participate in client audits and regulatory inspections, representing downstream operations. Evaluate and recommend new technologies or process innovations to enhance operational efficiency and purification capabilities. Perform other duties as assigned to ensure business and compliance needs are met. Working Conditions Work performed in both cleanroom and office settings. Position requires walking, standing, stooping, kneeling, and crouching. May occasionally lift or move up to 20 pounds independently. Qualifications BS in Life Sciences or related discipline with 8+ years of relevant experience, or an equivalent combination of advanced degree and relevant industry experience, preferably in biopharma manufacturing. Strong knowledge of cGMP regulations and compliance as it pertains to biopharma manufacturing operations. In-depth understanding of downstream purification processes (affinity, IEX, SEC, viral inactivation/filtration, depth filtration, TFF, UFDF) and related equipment (e.g., GE ÄKTA systems, single-use technologies). Hands‑on experience with process execution, troubleshooting, development, and validation. Familiarity with process monitoring and control systems such as UNICORN and Pi Historian. Proven ability to supervise, coach, and motivate teams in a manufacturing environment. Strong organizational and prioritization skills; able to manage multiple projects in a fast‑paced, dynamic setting. Creative problem‑solver with the ability to identify opportunities for operational improvements. Strong communication and collaboration skills with cross‑functional teams. Compensation Range The base compensation range for this role is between $95,000 and $110,000 a year. The actual compensation may vary depending on your experience and qualifications. Benefits Bionova offers health benefits at a subsidized rate. Healthcare, Dental, and Vision insurance. Life Insurance and Disability Program: 100% covered by Bionova. Retirement Plan (401K) – Up to 8% employer match. Paid time off up to two weeks. 10 days of holidays and 5 days of sick leave. Equal Opportunity Employer Statement As an equal‑opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment. Senior level Mid‑Senior level Employment type Full‑time Job function Management and Manufacturing Referrals increase your chances of interviewing at Bionova Scientific by 2x. #J-18808-Ljbffr