Production Technician I

Job Title: Production Technician I                

Department: Manufacturing

About Pelthos:

Pelthos Therapeutics is a bio-pharmaceutical company committed to commercializing innovative, safe and efficacious therapeutic products to help patients with unmet treatment burdens. For more information, please visit our website at www.pelthos.com or follow us on LinkedIn and X. 

Job Summary:

The Production Technician is responsible for the safe manufacture of active pharmaceutical ingredients (APIs) and drug products in a Good Manufacturing Practice (GMP) environment. This position will operate, clean and maintain manufacturing equipment, instrumentation and facilities necessary to support GMP production processes in API manufacturing.

Essential Duties & Responsibilities:

Execute API/Drug Product manufacturing operations in the Company's current Good Manufacturing Process facility

Request and dispense raw materials for manufacturing

Operate process reactors, filters, dryers, fillers, milling and formulation equipment

Sample product, as directed, for testing

Clean and maintain production equipment and areas

Maintain a safe working environment

Observe and follow all safe operation practices

Complete and maintain documentation in accordance with expected Good Documentation Practices (GDP)

Follow and complete batch records

Fill out logbooks

Follow standard operating procedures (SOPs)

Ability to revise GMP documents preferred

Assist in deviation investigations and all other forms of GMP documentation

Maintain equipment and instrumentation necessary to support cGMP manufacturing of APIs as described in production batch records

Participate in preventative maintenance activities

Assist in maintaining equipment records

Troubleshoot equipment and manufacturing operations as needed

Suggest and implement improvements to operations

Monitor environmental parameters

Maintain inventory of consumables and supplies

Properly manage hazardous waste in their work area where hazardous waste is generated and/or accumulated

Other duties as assigned

Experience & Qualifications:

HS degree or equivalent

Experience with cleaning, maintaining and controlling equipment

1-2 years’ experience in a GMP manufacturing environment or equivalent

Experience with cleaning, maintaining and controlling qualified equipment

SOP writing experience preferred

Strong mechanical aptitude and critical thinking

Proficient with computers and basic math

Attention to detail and documentation

Ability to follow written and verbal technical instruction

Strong verbal and written communication skills

Proficiency in MS office preferred

Physical & Environmental Requirements:

The essential functions of this position include:

Ability to wear a required powered air purifying respirator (PAPR)

Lift up to 25lbs on a frequent basis

Lift up to 50lbs on an occasional basis

Stand, walk, sit, climb, balance, stoop, kneel, crouch or crawl on a frequent basis

Reach, hands and arms on a frequent basis

Use hands to feel on an occasional basis

Communicate using hearing and speech on a frequent basis

Use sense of smell and vision (color difference, depth perception) on a frequent basis

Up to 10% of travel (as needed)

These functions must be performed safely and effectively, without posing a direct threat to the employee or others, with or without reasonable accommodation.