Shift Supervisor

Position Summary:

The Shift Supervisor will be responsible for performing duties and functions relative to coordinating the planning, products, and materials through the manufacturing phases using the legacy company systems/processes in concert with the Production Manager. The individual will also assist in maintaining calibration of equipment, review of batch production records, procurement and management of raw materials, maintenance of GMP and environmental health and safety practices, and creation and revision of manufacturing documentation.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Essential Duties and Responsibilities: include the following. Other duties may be assigned.

· Display expertise in daily operations of manufacturing, rotary evaporation, chromatography, receiving and final processing departments in GMP manufacturing.

· Open and close Avanti campus

· Coordinate and monitor the movement of equipment, raw materials and products to assure successful on time deliveries in concert with the cGMP Production Manager.

· Assist in planning, processing and track status of production.

· Assist in review and creation of batch production records

· Assist in planning, procurement and management of raw materials

· Upload/input/update of production information in SmartSheet as required to facilitate long term production planning

· Prepare and maintain various reports and metrics on the progress of work, materials used, rates of manufacturing and other manufacturing information, using manual or computerized systems.

· Assist the cGMP Production Manger to process production related non-conformances expeditiously.

· Work as a liaison across departments/programs to identify and assist in removing bottlenecks in manufacturing and product delivery.

· Assist with continuous effort to improve operations, streamline work processes, and work cooperatively and jointly with all departments and vendors.

· Maintain a basic understanding of cGMP and compliance in a manufacturing setting.

· Accurate and timely creation and review manufacturing SOPs, BPRs and other manufacturing documentation.

· Assist in updating/revising SOPs and BPRs

· Other tasks as assigned to ensure smooth operation of cGMP Manufacturing.

· Prepare and align individual performance goals with department goals

· Complete company-required training programs

· Adhere to all applicable regulations, policies, and procedures for health, safety, and environmental compliance as outlined in the company's Standard Operating Procedures, Chemical Hygiene Plan, Emergency Contingency Plan, training memoranda, policy memoranda, Safety Data Sheets, Specification Records, etc.

Non-Essential Duties:

· Contribute to corrective and preventive action proposals

· Complete HAZWOPER training

· Perform facility opening/closing protocols

· Perform label printing and verification

· Perform upkeep of employee training records

· Perform as SME for QC/QA investigations

· Conduct laboratory duties in a cGMP/QMS environment

· Transfer hazardous or nonhazardous waste materials to collection areas for disposal or recycling

Supervisory Responsibilities:

Direct Supervisor of employees in chromatographic, rotary evaporation, glassware, operations and manufacturing departments.

• Pharmaceutical Manufacturing Specialist
• Pharmaceutical Manufacturing Technician
• Chromatography Technician
• Rotary Evaporation Technician
• Operations Technician
• Glassware Technician

Education and/or Experience: Bachelor of Science or equivalent unless previous employment experience indicates aptitude. Bachelor of Science in chemistry, chemical engineering, biology or related field preferred. Minimum 5 years’ experience in manufacturing environment. 1-2 years’ experience in pharmaceutical manufacturing in a cGMP environment preferred. Experience is supervisory role preferred.

Certificates, Licenses, Registrations:

Skills and Abilities:

· Self-motivated with a sense of urgency in day to day performance.

· Proficient in basic applications such as Word, Excel, Outlook

· Good command of the English language

· Basic math skills required

· High level of reasoning ability for strategic planning required

· High level of organizational ability and the ability to work with cross-functional teams required.

· Good knowledge of FDA regulations.

· Experience developing and writing manufacturing instructions and SOPs.

· Knowledge of laboratory practices.

· Proficient in the Microsoft Office suite.

· Demonstrated technical/analytical skills and attention to detail.

· Ability to successfully implement business processes.

· Ability to observe appropriate safety and study requirements.

· Good organizational skills.

· Understands and manages to strict timelines.

Other Qualifications:

Physical Demands: While performing the duties of this job, the employee is regularly required to talk, give oral instructions; listen and hear instructions, customer and/or employee responses, etc. The position is active and requires standing, walking, bending, kneeling and stooping all day. The employee must occasionally lift and/or move items up to 100 pounds.

Work Environment: Requires the ability to gown and wear safety attire as well as any required protective equipment including safety glasses. Employees must meet hygiene and health requirements to allow them to work in a cGMP environment. The job function routinely works with chemicals, organic solvents and biological samples, and may on occasion require work with caustic chemicals.

COMPANY POSITION STATEMENT

This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position. While this is intended to be an accurate reflection of the current job, Avanti Polar Lipids, Inc. reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g., emergencies, change in workload or technology developments).

Job Type: Full-time

Pay: $0.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Night shift
• Weekends

Education:

• Bachelor's (Preferred)

Experience:

• Chemistry, manufacturing & controls: 5 years (Preferred)
• Pharmacautical Manufactuirng: 1 year (Preferred)

Work Location:

• One location