Manufacturing Group Lead (1st & 2nd Shift)

The Manufacturing Group Lead serves as a hands-on, working lead responsible for supporting daily oral solid dosage manufacturing operations across areas such as weighing, blending, compression, coating, encapsulation, and related processes. This role provides rotating room coverage, helps direct floor execution during active operations, and independently operates manufacturing equipment as needed to support production goals. The Manufacturing Group Lead plays a key role in maintaining safe, efficient, and compliant operations by reinforcing adherence to approved batch records, SOPs, Good Documentation Practices, and cGMP requirements while serving as a day-to-day resource for manufacturing operators.

Key Responsibilities:

Set up, operate, monitor, and troubleshoot assigned oral solid dosage manufacturing equipment, including compression, encapsulation, weighing/blending, coating, and fluid bed drying systems, in accordance with approved batch records and SOPs.

• Provide rotating room leadership during active operations by directing workflow, monitoring operator execution, and ensuring adherence to batch instructions, safety requirements, and cGMP standards.

• Perform and verify in-process checks, support line clearance, and help oversee equipment cleaning, changeovers, and room readiness to ensure compliant and efficient manufacturing execution.

• Train and coach manufacturing operators on equipment operation, documentation practices, gowning, line clearance, and safe material handling while reinforcing strong floor discipline and compliance expectations.

• Review batch records, logbooks, and production documentation for completeness, legibility, accuracy, and Good Documentation Practices compliance.

• Coordinate cross-functionally to address operational issues, escalate concerns, and support uninterrupted production.

What We're Looking For

Experience:

• Minimum of 5 years of pharmaceutical manufacturing experience in a cGMP-regulated environment required.

• Candidates with 3–4 years of directly relevant pharmaceutical manufacturing experience may be considered if they demonstrate strong technical capability across multiple OSD processes, prior lead coverage or informal team leadership experience, and a strong record of compliance, attendance, and performance.

• Hands-on experience with oral solid dosage manufacturing operations such as weighing, blending, compression, coating, encapsulation, and equipment changeovers required.

Education:

• High school diploma or equivalent required.

• Technical school training or coursework in manufacturing or a related field preferred.

Skills & Knowledge:

• Advanced operational knowledge of multiple oral solid dosage manufacturing processes and related equipment.

• Strong understanding of cGMP requirements, FDA expectations, and data integrity principles.

• Ability to identify operational issues, troubleshoot effectively, and support timely resolution.

• Strong attention to detail with the ability to review documentation accurately and maintain inspection-ready standards.

• Ability to provide effective floor leadership, operator coaching, and day-to-day support in a working lead capacity.

• Strong written and verbal communication skills with the ability to work effectively with different departments.

What We Offer

• Competitive compensation with annual performance bonus eligibility

• Annual merit-based pay increases

• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed

• Paid Time Off

• 10 paid company holidays

• Comprehensive medical, dental, vision, and life insurance coverage

• Professional development reimbursement

• Career growth opportunities

• Tuition reimbursement for children and childcare expense reimbursement

Schedule

• This is a full-time, on-site position (1st Shift: Monday–Friday, 7:00 AM – 3:30 PM; 2nd Shift