Lead Aseptic Fill-Finish Manufacturing Associate

Pscbiotech; York (York County); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, and Vision benefits

Relocation assistance

401(k) matching

Paid time off

Education assistance

Life Insurance and Disability coverage

Pet Insurance

Job summary

PSC Biotech is seeking a manufacturing professional to join our aseptic operations. The role involves complex tasks under GMP/ISO guidelines, including filling, formulation, and equipment prep for sterile injectable products. You will collaborate across engineering, QA, and facilities, maintaining rigorous documentation and batch records.

The ideal candidate has a life sciences degree with 5–7 years in a regulated facility, strong communication, and a willingness to work extended hours as needed.

Qualifications

• Bachelor’s Degree in Life Sciences or Liberal Arts, or equivalent experience.
• 5-7 years of professional manufacturing experience in an aseptic FDA‑regulated facility.
• Experience with sterile injectable drug products and aseptic technique.
• Willingness to work extended shifts and a variable schedule when required.
• Skilled in MS Office/Excel tools.
• Excellent verbal and written communication skills.

Responsibilities

• Perform a variety of complex manufacturing tasks under guidance per GMP/ISO standards.
• Execute aseptic and non-aseptic filling, equipment prep, cleaning, dissolution and formulation.
• Support other departments such as engineering, warehouse and facilities as needed.
• Maintain documentation, GDP compliant batch records and logbooks.
• Lead or support cross‑functional teams in manufacturing activities.
• Revise and author SOPs and Batch Records; participate in investigations.
• Assist with tech transfer, process validation, and equipment commissioning activities.
• Ensure sanitization, sterilization practices are followed and schedule changes communicated.

Skills

Attention to detail

Communication skills

Self-motivated

MS Office/Excel

Education

Bachelor's Degree in Life Sciences or Liberal Arts

Tools

MS Office/Excel

Job description

PSC Biotech is seeking a manufacturing professional to join our aseptic operations. The role involves complex tasks under GMP/ISO guidelines, including filling, formulation, and equipment prep for sterile injectable products. You will collaborate across engineering, QA, and facilities, maintaining rigorous documentation and batch records.

The ideal candidate has a life sciences degree with 5–7 years in a regulated facility, strong communication, and a willingness to work extended hours as needed.