Manufacturing Associate, Lead – Parenteral Filling (Nights)

Biogen•Research Triangle Park, NC

5d•$33 - $43

About The Position

Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. Shift Details: 12-hour shifts Nights: 6:00 PM – 6:00 AM Rotating 2-2-3 schedule The Manufacturing Associate, Lead plays a critical hands-on leadership role within a cGMP manufacturing environment, performing and documenting daily manufacturing operations while ensuring compliance, quality, and efficiency. This role works closely with the Manufacturing Supervisor to coordinate shift activities, allocate resources, and support production, validation, and continuous improvement initiatives.

Requirements

The following combinations of education and direct experience will be considered:
Bachelor’s degree in Science, Technology, Engineering, or Mathematics (STEM) or a related field from an accredited college or university with a minimum of 4 years of direct experience
Associate’s degree in Science, Technology, Engineering, or Mathematics (STEM) or related field from an accredited institution with a minimum of 4.5 years of direct experience
High school diploma or equivalent with a minimum of 5 years of direct experience
Demonstrated experience working in a cGMP manufacturing environment
Strong documentation, compliance, and process execution skills
Ability to lead tasks, support teams, and collaborate effectively across shifts

Nice To Haves

Prior Parenteral Filling experience
Experience with TrackWise, DeltaV, and LIMS systems

Responsibilities

Execute manufacturing processing steps and manufacturing support activities in accordance with batch records, SLRs, control systems, and standard operating procedures.
Monitor and control processes, serving as a subject matter expert (SME) for assigned unit operations and process steps.
Coordinate and, as required, lead process steps while ensuring adherence to cGMP requirements.
Partner with the Supervisor to schedule daily shift activities, plan resource allocation, and support production, validation, and project-related work.
Ensure effective shift handoffs through clear communication of issues, priorities, and status updates.
Document, review, and ensure completeness of cGMP documentation including batch production records (BPRs), SLRs, deviations, and equipment logbooks, with real-time review for accuracy and compliance.
Develop, revise, and maintain cGMP documents as needed.
Actively participate in training activities, manage individual training plans, and provide hands-on training and knowledge sharing to other associates.
Observe employee performance, provide timely coaching, and deliver feedback to the Supervisor during mid-year and end-of-year evaluations.
Initiate and investigate deviations, support root cause analysis, and develop corrective and preventive actions (CAPAs) under Supervisor guidance.
Lead or participate in troubleshooting efforts and serve as a potential SME during audits.
Support equipment and facility maintenance activities to ensure operational readiness and compliance.

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation