Job Description

Position Summary:

Manages the day-to-day affairs of an organization by assisting the Sr. Director, Manufacturing in medium and long term scheduling, strategically lead on high profile projects, and to assess and respond to urgent operational issues. The position also manages people by coaching, mentoring, recognition, and disciplines.

The individual will oversee operations in upstream, downstream, manufacturing support and cleaning activities.

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 will teach, promote and enforce precise and compliant operations.

The 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 Sr. Director or designee of Manufacturing on daily tasks. These daily tasks may include:

• Strategic leader on high-profile projects

• Medium and Long – Term Scheduling

• Assess and respond to urgent operational issues

• Managing people through coaching and discipline

• Oversee all manufacturing ops including upstream, downstream, and support services

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.

• Direct support to Sr. Director or designee of Manufacturing on daily tasks. These daily tasks may include:

• Inter Departmental coordination and scheduling support

• Hiring of manufacturing personnel

Requirements:

• Bachelor’s degree in a related scientific or engineering discipline is preferred and 10+ years’ experience in related GMP manufacturing operations or equivalent education and experience.

• 6+ years prior leadership/supervisory experience for Sr. Manager.

• Demonstrated knowledge of mammalian cell culture unit operations is preferred.

• Experience in single-use platform technology is preferred.

• Excellent written and verbal communication skills are required.

• Energetic, motivated and dynamic individual.

• Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.

• Must possess strong leadership, ability to hold team accountable, manage difficult conversations, and discipline when necessary.

Language Ability
Fluent in English Language both reading and writing. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.

Reasoning Ability
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Math Ability
Ability to develop and solve algebraic and exponential math problems by hand or using software. Ability to apply basic statistics to sets of values and develop and interpret different types of graphs

Computer Skills
MS Office, ERP, EDMS, production equipment software, other Equipment Use

Working Conditions

The job requires working 8 hour shifts M-F from 6pm to 3am and may change per the discretion of the head of manufacturing. 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.

Salary Range: $133,000 - $183,700

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

About KBI:

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.