Company

Prolacta is the pioneer in human milk-based nutritional products for premature infants in the neonatal intensive care unit (NICU). Prolacta believes that there is no adequate replacement for human breast milk and, as such, we believe infant nutritional products should be human milk-based. As a privately held, scientifically driven company, committed to improving premature infant nutrition, we are using human milk to change the standard of care in the NICU. Prolacta operates and/or owns milk banks that provide the starting material for the products Prolacta sells.

Job Summary

This position is responsible for executing Prolacta’s manufacturing processes while strictly adhering to current Good Manufacturing Practices (cGMP’s), Environmental Health & Safety guidelines, and other regulations that apply. The incumbent is responsible for executing, coordinating, and supervising all daily job assignments for the day-to-day production activities required by the Prolacta Bioscience manufacturing processes.

 Work environment ranges from 25 degrees Celsius to -20 degrees Celsius for short periods of time to retrieve raw milk materials from the freezer. This job requires pushing, pulling, and lifting heavy equipment while working in clean rooms that require full gowning. Gowning includes the use of coverall type gowns, hoods, boots, gloves, and masks.

 

Primary Duties and Responsibilities

·       Subject Matter Expert of the following production activities: 

o   Thawing and pooling of raw milk

o   Aseptic sampling

o   Preparation of cleaning solutions

o   Operation of mixers

o   Operation of chart recorders

o   Disassembly and assembly of process equipment

o   Cleaning and sanitizing of Facility and Equipment

o   General housekeeping

o   Packaging of products.

o   Set up and operation of separators

o   Handling, storage and use of intermediates

o   Operate milk analyzing equipment

o   Adjustment and formulation of all products

o   Set up and operation of filter skid

o   Milk filtration process

o   Operation of CIP skid

o   Cleaning, Operation, and testing of the Ultrafiltration skid

o   Mineral calculation and addition

o   Pasteurization

o   Filling machine operation

o   Aseptic sampling of water system and finished goods

·       Process start-up and control

·       Meet production schedule and goals

·       Respond to technicians’ issues/request

·       Manage Paid Time Off

·       Manage Over Time

·       Manage and approve Technician Time Sheets

·       Assist in writing and deliver year end reviews

·       Confirm quality-routine checks on controlled forms and/or batch records

·       Cover absenteeism

·       Training and cross-training of Manufacturing Technicians

·       Be familiar with area SOPs and ensure standardized work is followed

·       Facilitate small group activities

·       On-going continuous improvements projects

·       Ensure parts/material are supplied to process

Job Requirements and Qualifications

•  Average Years of Experience: 3 years, 1-2 years in related role·      
• Typical Education Level: High School Diploma, Bachelor's Degree preferred
  

 

Additional Job Functions

 •           Able to perform supervisor duties and responsibilities when needed

•           Facilitate and/or support Manufacturing Facility 5S; tour/audit ready at all times

•           Work closely with Quality and Manufacturing Engineers to resolve manufacturing challenges.

•           Support R&D projects as needed.

•           Document and/or support Observation Reports (OR), Non-Conformance (NC), Corrective Actions (CA), Change Controls (CC), Internal Audits, or any other quality systems.

•           Assist management with team morale, metric reports, employee development, training, etc.

Other Knowledge, Skills and Abilities

• Some experience in managing budget
• Ability to work without supervision
• Handle conflict management and bring resolution
• Effective relationship building skills
• Ability to produce and present clear, concise and professionally written communications and presentations
• Performance coaching and directing of others
• Positive attitude and motivation
• Ability to operate in a complex matrix environment
• Strong PC skills, MS Outlook, Word, etc.
• Must be able to work under pressure, meet deadlines, and be flexible when working on multiple projects simultaneously
• Strong Critical thinking and decision-making skills
• Strong business ethics
• Scorecard management
• For manufacturing Lean and Six Sigma qualified

 

Work Environment (Location, travel, shift, on-call, etc.)

Travel         

<1% 

Location      

City of Industry

Direct Reports 

Technician 1 – Manufacturing

Technician 2 - Manufacturing

Technician 3 - Manufacturing

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

 

“Prolacta Bioscience, Inc. is an Equal Employment Opportunity Employer.” Prolacta Bioscience, Inc. is committed to a proactive program of affirmative action and diversity development. The Company will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.