Lead, Manufacturing - Solution Prep (Days)

Scorpion Therapeutics; North Carolina; On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Health insurance

401(k) match

Tuition reimbursement

Paid time off

Job summary

Scorpion Therapeutics in North Carolina is seeking a Manufacturing Lead to perform and document daily manufacturing operations in a cGMP environment, operate process equipment, and support validation and document control. The role works closely with the shift Supervisor and prepares for the Manufacturing Supervisor.

You will lead cross-functional shift activities, schedule tasks, review batch records, and train others.

Qualifications

• Bachelor’s degree in STEM with 4+ years in manufacturing.
• Alternative: BioWorks cert/associate’s in STEM with 4.5+ years.
• High school diploma with 5+ years in cGMP manufacturing.

Responsibilities

• Execute manufacturing steps; monitor batch records and control systems.
• Schedule tasks and allocate resources across shift.
• Document cGMP data and review deviations.
• Participate in training and coach shift team.
• Lead deviations and CAPAs; support audits.
• Serve as on-shift technical point of contact.

Skills

Leadership

cGMP knowledge

Shift coordination

SOPs & GDP

Aseptic/cleanroom

Downstream prep

Quality systems

Education

Bachelor STEM

BioWorks cert/AS STEM

HS diploma

Tools

Trackwise

DeltaV

Syncade

LIMS

Job description

Shift Details:

• 2-2-3 calendar rotation on days (6:00 AM–6:00 PM ET)

The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment, including operating process equipment, executing validation protocols, revising cGMP documents, ensuring cGMP compliance, and maintaining equipment and facilities. Works closely with the shift Supervisor; serves as a key preparatory role for Manufacturing Supervisor.

What You’ll Do

• Execute manufacturing processing steps/support activities; monitor against batch record, SLR, and control system; coordinate/lead as process step expert.
• In coordination with Supervisor: schedule shift tasks, plan resource allocation (production/validation/projects), ensure proper information sharing at shift exchange, and communicate issues.
• Document/record and review cGMP data; document deviations; develop/revise documents (batch records, SLRs, equipment logbooks); ensure BPR/SLR real-time review completeness.
• Participate in training; manage individual training plan; train others; coach and provide feedback to Supervisor.
• Initiate/investigate deviations; develop/implement CAPAs; lead/participate in troubleshooting; serve as possible SME for audits.
• Serve as operational point of contact during assigned shifts for technical guidance and real-time decisions.

Required Skills

• Bachelor’s (STEM preferred) + 4 years; or BioWorks certificate/associate’s (STEM) + 4.5 years; or HS (or equivalent) + 5 years.
• Leading manufacturing activities; coordinating across shift team; training in cGMP.
• Follow SOPs and GDP.
• Aseptic/cleanroom experience.
• Downstream/buffer prep experience in cGMP.
• Trackwise, Delta V, Syncade, LIMS (or similar).

Preferred Skills

• Leadership experience in buffer prep/downstream.
• Lean, Six Sigma, 5S certifications.

Benefits (as listed)

• Medical, dental, vision, life; fitness reimbursement; short-/long-term disability; paid vacation (min 15 days) plus Dec 26–Dec 31 shutdown; holidays and paid personal days; sick time; paid maternity/parental leave; 401(k) match; stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.