Bioprocess Operations Specialist

Location: Skokie, IL

Salary: $65,000–$75,000

Equity: 100 shares

Bonus: 10% target

Job Type: Full-time, Onsite

Senior Bioprocess Operations Specialist

Location: Skokie, IL

Salary: $90k-100k

Equity: 1000 shares

Bonus: 10% target

Job Type: Full-time, Onsite

Position Summary:

We are seeking an experienced Bioprocess Operations Specialist or Senior Bioprocess Operations Spec. with a strong background in GMP manufacturing and cleanroom operations. This role is ideal for someone who thrives on the production floor, has hands-on manufacturing experience in a regulated pharmaceutical environment, and possesses excellent technical writing skills for creating and revising documentation such as SOPs and MBRs.

Key Responsibilities:

• Perform hands-on drug substance and drug product manufacturing in a cleanroom setting.
• Execute daily manufacturing operations by following SOPs, batch records, and work instructions.
• Draft and revise technical documentation, including SOPs and manufacturing batch records (MBRs).
• Support cleaning validation, environmental monitoring, and inventory management activities.
• Ensure manufacturing areas and equipment are maintained to meet GMP and safety standards.
• Collaborate with Quality and Development teams to ensure smooth operational workflows.
• Participate in cross-functional projects as needed.

Required Qualifications:

• Minimum 3-5+ years of hands-on experience in GMP manufacturing; recent pharma floor experience required. Ideally 5-8+ years preferred for senior title.
• Demonstrated experience in cleanroom environments.
• Strong knowledge of FDA, cGMP, and ICH regulatory requirements.
• Proven ability to follow detailed procedures and maintain compliance in a regulated environment.
• Proficient in drafting and revising SOPs and technical documentation.
• Experience with cleaning programs and materials management systems.
• Excellent organizational, verbal, and written communication skills.
• Comfortable working in a fast-paced, multi-tasking environment.

Preferred:

• Bachelor’s degree in a scientific or technical field is preferred but not required with strong relevant experience.

Additional Notes:

• Candidates must have recent industry experience in pharma or biotech manufacturing—academic or returning-to-industry profiles will not be considered.
• Strong preference for candidates with at least 2 years in their most recent role as a Manufacturing Associate or BPE.