Biomanufacturing Downstream

Responsibilities:

• Oversee nightly execution of downstream biologics manufacturing in compliance with SOPs and cGMP guidelines.
• Lead, coach, and develop a team of 5–15 operators and specialists, ensuring batch readiness and schedule adherence.
• Provide on-the-floor support for column chromatography, NFF/TFF operations, viral reduction/filtration, and bulk drug substance filling.
• Drive standard work and coordinate with supervisors across shifts to ensure consistent execution.
• Promote a right-first-time culture and continuous improvement to meet client and site objectives.
• Support Person In Plant (PIP) activities and customer interactions during runs as needed.
• Assign, review, and check work while removing routine obstacles to maintain throughput and compliance.
• Participate in hiring, performance reviews, salary reviews, and application of company policies.

Required Skills & Qualifications:

• Education and experience (one of the following): Doctorate with 3+ years, Masters with 6+ years, Bachelors with 7+ years, Associates with 9+ years, or High School Diploma with 10+ years in a scientific, engineering, or biomanufacturing discipline.
• More than 2 years of leadership experience overseeing manufacturing or laboratory teams.
• Proficiency in downstream unit operations, including chromatography, NFF/TFF, viral filtration, and bulk filling.
• Excellent written and verbal communication skills with internal and external customers, including the ability to convey complex technical information to non-technical audiences.
• Demonstrated ability to maintain data integrity and comply with SOPs, specifications, and cGMP, ICH, FDA, EMA regulations and guidelines.
• Ability to lead difficult discussions and drive resolution with customers and team members.
• Capability to interpret data across multiple disciplines and understand the end-to-end biologics process in area of expertise.
• Organized with the ability to handle and direct multiple activities simultaneously.

Preferred Skills:

• Cleanroom operations, aseptic technique, and general laboratory equipment experience.
• Prior cGMP manufacturing experience in clinical or commercial settings.

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