Pisgah Labs Inc Hiring for Aseptic Operations Manager Full Time

This position is located in Pisgah Forest, NC and relocation is required with relocation assistance available.

Pisgah Labs

Pisgah Labs is an FDA licensed GMP Active Pharmaceutical Ingredient (API) manufacturer in Pisgah Forest, NC. We have initiated a large expansion of our facility to add Sterile Injectable Final Dose manufacturing beginning with a pilot facility and advancing to a commercial facility in the future. Pisgah is a small corporation with approximately 30 employees and the expansion of our site will add 55-60 new jobs. The company offers benefits such as medical, dental and vision, 401K, and ancillary insurance benefits to employees as well as a PTO program and paid holidays.

Summary

We are seeking an Aseptic Operations Manager for the greenfield expansion. The Aseptic Operations Manager will have 10-20 years’ experience as a supervisor or manager of Sterile Formulations. Candidates having hands on experience with handling lyophilized products will be an added advantage.

Essential Functions

· Responsible for the management and oversight of the Aseptic Operations of the new injectable facilities.

· Ensure quality of work, productivity and planning for sterile manufacturing and organize, schedule and direct workflow to meet company milestones and timelines.

· Ensure that operations meet regulatory standards and company needs as they pertain to Sterile manufacturing (FDA, ICH, USP, EP, ect).

· Must have hands-on experience in batch processing, fill/finish, sterilization, cleanroom practices, and packaging of injectable drugs.

· In-depth understanding and experience of Facility & Equipment Operations, Troubleshooting, Qualification and Validation

· Responsible for training of sterile manufacturing staff.

· Must have in-depth knowledge of cleanroom operation, HVAC and water systems.

· Experience in commissioning and qualification of a greenfield facility would be an additional advantage.

· Write, review and implement SOPs and protocols to stringent regulatory requirements.

· Investigation of deviations, and implementation of Change Controls and Corrective and Preventive Actions.

· Overseeing product transfer/process optimization/qualification/validation activities for various utilities, equipment and processes.

· Part of the audit team for internal, regulatory and customer audits.

· Maintain a clean and safe work environment.

· Comply with waste management practices.

· Complete 8 hours of safety training within 6 months

· Complete HAZWOPER training within 6 months

· Adhere to site-wide safety and security procedures.

Attributes

· A legal U.S. citizen

· Ability to pass a pre-employment respiratory physical exam, hearing test and drug/alcohol screen.

· Ability to read and write in English.

· Ability to pass a criminal background check.

· Ability to work independently with little or no supervision to complete assigned tasks.

· Extensive knowledge of sterile manufacturing techniques

· Extensive knowledge of Regulations and guidance documents (FDA, ICH, PIC/S, USP, EP)

· Availability 24 hours a day, 7 days a week

· Ability to solve complex problems and implement necessary corrections in timely manner.

· Ability to manage, teach and train other employees.

· Strong numerical and analytical skills

· Ability to read and understand safety rules and procedures for handling chemical substances.

· Working knowledge of Microsoft Office Products

· Ability to wear and utilize any necessary personal protective equipment.

· Ability to communicate in an open and honest manner.

· Support a strong work/safety ethic throughout the organization.

· Ability to function as a team player with good interpersonal skills.

· No known or uncontrolled allergies to common chemicals used in a pharmaceutical environment.

Supervisory Responsibilities

This position has supervisory responsibilities of managing 10-20 employees in sterile injectable manufacturing.

Work Environment

Employee will generally work in a temperature controlled GMP environment and will have exposure to a wide variety of chemical materials. Employee is expected to wear cleanroom gowning and any necessary PPE, as needed. Employee will utilize general office equipment including computers, printers, office machines and other office related items. Employee will also have frequent exposure to the manufacturing facilities, bulk chemicals, and hazardous materials.

Physical Demands

The position requires moderate physical exertion such as operating equipment, repetitive motions, standing and sitting for varying periods. The employee will also need the physical ability to lift moderately heavy objects (at least 50 pounds). Employee may be exposed loud sounds, running machinery, bulk chemicals and varying temperature changes in manufacturing facilities.

Position Type/ Expected Hours of Work

This is an exempt, full-time salaried position. Employee should be available to work shifts, overtime and weekends as required by senior management and project goals.

Travel

The position may involve travel to train, assist clients or attend industry functions.

Education/Experience

· Minimum Bachelor’s in Pharmaceutical Sciences, Chemistry or related field.

· At least 10 years’ experience in sterile manufacturing and packaging.

· At least 5 years’ experience in management and/or supervision of other employees.

· At least 5 years’ experience in project planning, scheduling and coordination.

AAP/EEO Statement

Pisgah Labs, Inc. is an Equal Opportunity Employer. Pisgah provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law. Pisgah Labs will not tolerate discrimination or harassment based on any of these characteristics. Pisgah Labs is committed to achieving a diverse workforce through application of its affirmative action, equal opportunity, and nondiscrimination policy in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

Pisgah Labs welcomes all applicants equally. If you are smart, hard-working and honest you belong at our company!

Job Type: Full-time

Pay: From $80,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 10 hour shift
• 12 hour shift
• 8 hour shift
• Day shift
• Evening shift
• Monday to Friday
• Night shift
• Weekend availability

Work Location: One location