Lead, Manufacturing (Days)

Our factories run 24/7 operations. Manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. This role follows a 2-2-3 calendar rotation on days (6:00 AM – 6:00 PM ET) with a Black Days rotating schedule.

About the role

The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment, including operation of process equipment, execution of validation protocols, revising cGMP documents, ensuring compliance, and maintaining equipment and facilities. This position works closely with the shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently. This is a key preparatory role for the Manufacturing Supervisor position.

Responsibilities

• Execute manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR, and control system.
• Coordinate and/or lead process steps as required, serving as a process step(s) expert.
• In coordination with Supervisor, schedule tasks for a given shift and plan resource allocation, including production, validation, or other project activities.
• Ensure proper information sharing at shift exchange and communicate all issues appropriately.
• Document, record, and review cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures.
• Develop and/or revise documents as needed, including batch records, SLRs, and equipment logbooks.
• Ensure completeness of BPR/SLR real-time review.
• Actively participate in training activities, manage your own individual training plan, and provide training to other associates as required.
• Observe performance of employees, provide timely and targeted coaching, and provide feedback to Supervisor mid and end of year.
• Initiate and investigate deviations, develop and implement corrective and preventative actions as required by supervisor.
• Lead and/or actively participate in troubleshooting; serve as possible SME for audits.
• Serve as the operational point of contact for associates during assigned shifts, providing technical guidance, troubleshooting support, and real-time decision making.

Requirements

The following combination of academic and/or relevant experience may be considered:

• Bachelor’s degree from an accredited college or university, STEM preferred, and at minimum 4 years of direct experience.
• BioWorks Certificate or associate's degree, STEM preferred, and at minimum 4.5 years of direct experience.
• High School Diploma (or equivalent) and at minimum 5 years of direct experience.
• Demonstrated experience leading manufacturing activities, coordinating work across a shift team, and training associates in a cGMP environment.
• Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP).
• Experience working in an aseptic or cleanroom environment.
• Experience supporting downstream manufacturing operations and/or buffer preparation processes in a cGMP manufacturing environment.
• Experience with Trackwise, Delta V, Syncade, LIMS, and/or similar systems.

Preferred Skills

• Prior buffer preparation or downstream experience in a leadership capacity.
• Lean, Six Sigma, and 5S certifications.

Pay

The base compensation range for this role is $33.17 - $43.27 per hour. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

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.

About Us

We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission.