Manufacturing Associate-Filling 1st Shift

Scorpion Therapeutics; United States; On-site; USD 21,000 - 32,000; Full time

Job summary

Scorpion Therapeutics in Wilmington, OH is seeking a Manufacturing Associate to perform aseptic filling of microspheres, suspensions, and liquids, while following SOPs and maintaining gowning qualification. The role requires maintaining training proficiency in the Learning Management System and strict cGMP documentation.

Responsibilities include reading SOPs, documenting work per cGMP, operating filling equipment, supporting development/validation activities, and adhering to safety requirements.

Qualifications

• Manufacturing Associate 1 requires HS diploma/equivalent; preferred 0–1 year sterile pharma; associate+ in science/technical.
• Manufacturing Associate 2 requires HS diploma/equivalent; 1–3 years pharma manufacturing; preferred 1+ year sterile; associate+ in science/technical.
• Manufacturing Associate 3 requires HS diploma/equivalent; 4–5 years pharma manufacturing; preferred 2–3 years sterile; associate+ in science/technical.

Responsibilities

• Read and follow SOPs/MPRs/procedures.
• Document all work per cGMP on a timely basis.
• Execute tasks with close attention to detail; monitor the process.
• Follow internal policies and all safety requirements.
• Perform aseptic gowning (hood, coverall, boots, mask, goggles, gloves) and maintain qualification.
• Perform clean room sanitizations; equipment prep/assembly/setup.
• Operate filling equipment for microspheres/suspensions/liquids.
• Assist with development and validation activities as required.
• Other tasks as assigned; shift coverage/weekend work may be required.

Skills

Aseptic fundamentals

cGMP compliance

Mechanical aptitude

Computer skills

Education

HS diploma or equivalent

Associate+ in science/technical

Job description

Location: Wilmington, OH

Summary

• Perform operational activities for filling microsphere/suspension/liquid products, including equipment cleaning/assembly/setup, equipment operation, and batch processing.
• Read and follow SOPs/MPRs with thorough cGMP documentation.
• Aseptically gown and maintain gowning qualification; perform area sanitizations as needed.
• Maintain training proficiency via the Learning Management System.

Responsibilities

• Read and follow SOPs/MPRs/procedures.
• Document all work per cGMP on a timely basis.
• Execute tasks with close attention to detail; monitor the process.
• Follow internal policies and all safety requirements.
• Perform aseptic gowning (hood, coverall, boots, mask, goggles, gloves) and maintain qualification.
• Perform clean room sanitizations; equipment prep/assembly/setup.
• Operate filling equipment for microspheres/suspensions/liquids.
• Assist with development and validation activities as required.
• Other tasks as assigned; shift coverage/weekend work may be required.

Skills/Abilities

• Aseptic fundamentals; math skills (metric system).
• Adherence to cGMP; knowledge of HAZCOM, RCRA, and safety requirements.
• Mechanical aptitude for minor non-routine adjustments and diagnosing equipment.
• Computer skills; excellent documentation.

Qualifications

• Manufacturing Associate 1: HS diploma/equivalent; preferred: 0–1 year sterile pharma; associate+ in science/technical.
• Manufacturing Associate 2: HS diploma/equivalent; 1–3 years pharma manufacturing; preferred: 1+ year sterile; associate+ in science/technical.
• Manufacturing Associate 3: HS diploma/equivalent; 4–5 years pharma manufacturing; preferred: 2–3 years sterile; associate+ in science/technical.

Physical Requirements

• Maintain aseptic gowning (annual requalification); lift/move up to 50 lbs overhead; team lift up to 100 lbs; stand 7+ hours in steel-toed shoes; walking/lifting/reaching/climbing/bending; operate production equipment.

Personal Attributes

• Positive attitude, integrity/ethics, adaptability, dependability, detail-oriented, self-motivated, team-oriented, ownership/willingness to learn.