Job Description

Manages the day-to-day affairs of an organization by assisting the Director, Manufacturing in medium- and long-term scheduling, strategic lead on high profile projects, and to assess and respond to urgent operational issues.

The individual will also be responsible for ensuring MRP transactions, manufacturing record reviews, maintenance activities, and compliance documents are completed timely and thoroughly. The individual will ensure that manufacturing records and materials are available for timely execution of activities to meet production schedules.

This proven and qualified candidate will use their past experiences, depth and knowledge of biopharmaceutical operations to teach, troubleshoot, and continuously improve the production operations at the facility. The ideal candidate will be both technically sound as well as an experienced team motivator and coach.

Demonstrated knowledge of mammalian cell culture, purification, and solution preparation activities is expected as the Manager/Sr. Manager will teach, promote and enforce precise and compliant operations.

The Manager/Sr. Manager will use their leadership and technical expertise to drive process improvement initiatives, monitor processes and equipment, and troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed.

JOB RESPONSIBILITIES

Direct support to Director, Manufacturing on daily tasks.

These daily tasks may include:

• Strategic lead on high-profile projects
• Medium and Long – Term Scheduling
• Assess and respond to urgent operational issues.
• Inter Departmental coordination and scheduling support.
• Hiring manufacturing personnel.

Manufacturing Operations Support:

• Support operations to ensure MRP transactions, manufacturing record reviews, and maintenance activities are completed timely and thoroughly.
• Support operations to ensure deviations, CAPAs, and Change Controls are completed timely and thoroughly.
• Training, coaching and mentoring manufacturing supervisors and associates.

Process Improvement Initiatives:

• Identify and implement continuous improvement projects to increase safety, reliability, speed, and quality.

MINIMUM REQUIREMENTS

• Demonstrated knowledge of purification operations is highly preferred.
• Experience in single-use platform technology is preferred.
• Experience with regulatory and client inspections is preferred.
• Excellent written and verbal communication skills with application in a team-oriented environment are required.
• Energetic and motivated individual.
• Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor

Manager Bachelor’s degree in a related scientific or engineering discipline is preferred and 8+ years’ experience in related GMP manufacturing operations; 3+ years prior supervisory experience

Sr. Manager Bachelor’s degree in a related scientific or engineering discipline is preferred and 10+ years’ experience in related GMP manufacturing operations; 5+ years prior supervisory experience preferred.

WORKING CONDITIONS

Working conditions associated with this position include working 8-hour shifts M-F. The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee oversees staff who utilize equipment and materials which include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards. The noise level in the environment is moderate to high.

NOTE: Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.