Blow Fill Seal (BFS) Production Manager (DAYS) - 2 Positions

Description

Job Purpose: 

The Blow-Fill-Seal (BFS) Production Manager is responsible for leading, managing, and optimizing the day-to-day operations of BFS manufacturing processes within a sterile pharmaceutical environment. This role ensures that production goals are met safely, efficiently, and in compliance with cGMP regulations, FDA guidelines, and internal quality standards.

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Essential Duties and Responsibilities: 

Operational Oversight:

Ø Coordinates daily operations according to production planning, calculating potential impact related to BFS filling lines to include formulation, filling, and packaging.

Ø Oversees staffing to facilitate production planning adherence and execution to meet output, quality, and efficiency targets.

Ø Ensure equipment uptime, coordinate with maintenance and engineering teams for repairs and preventive maintenance.

Compliance & Quality Assurance:

Ø Ensure adherence to cGMP, FDA, EU, and other regulatory requirements.

Ø Support internal and external audits and implement corrective/preventive actions (CAPAs) as necessary.

Ø Monitor and improve aseptic technique and sterility assurance within the BFS environment.

Team Leadership & Development:

Ø Lead and develop a team of supervisors, operators, and technicians.

Ø Provide training, performance feedback, and enforce compliance with SOPs and safety policies.

Ø Foster a culture of continuous improvement, accountability, and safety.

Process Improvement:

Ø Identify and implement process improvements, automation opportunities, and cost reduction strategies.

Ø Participate in investigations (e.g., deviations, OOS, complaints) and drive root cause analysis.

Documentation and Reporting:

Ø Ensure accurate documentation of production batch records, logbooks, and related records.

Ø Track KPIs such as yield, downtime, deviation rate, productivity, and report to senior leadership.

Supplemental Functions: 

Ø Performs all other duties as assigned or apparent.

Job Specifications and Qualifications: 

Knowledge:

Ø In-depth knowledge of BFS technology (e.g. Rommelag, Weiler,or equivalent)

Ø Strong understanding of aseptic processing, sterile filling, and regulatory compliance.

Ø Proven leadership and team development skills in a fast-paced, regulated environment.

Ø Proficient in cGMP documentation and validation practices.

Education / Experience:

Ø Bachelor’s or Master’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or a related field.

Ø Minimum 5 years in pharmaceutical manufacturing, with at least 3 years in BFS production.

Licensing and Certifications:

Ø Lean Six Sigma Black Belt Preferred, minimum Green Belt held. 

Ø Gown certification required.

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Working Conditions / Physical Requirements:

Ø This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.

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The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. 

Nephron Pharmaceuticals is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.