Lead, Manufacturing - Large Scale Purification (Days)

NCBioImpact; Durham (NC); Presencial; USD 46 000 - 60 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Short- and Long-Term Disability

Paid vacation and year-end shutdown

Paid holidays and personal days

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Resumo da oferta

Biogen in Durham, NC is seeking a Manufacturing Lead to run 12-hour shifts on a 2-2-3 calendar in a 24/7 operation. Responsibilities include executing manufacturing steps, coordinating shift tasks, and maintaining cGMP documentation.

You’ll train staff, investigate deviations, and support audits while partnering with the shift supervisor to optimize production. Qualified candidates bring a strong background in aseptic environments, SOPs, GDP, and Trackwise/LIMS systems, with a minimum 4 years of

Qualificações

• Bachelor’s degree in a STEM field with relevant manufacturing experience.
• 4+ years of direct experience leading manufacturing activities in a cGMP environment.
• Experience with SOPs, GDP, aseptic or cleanroom operations, and downstream manufacturing support.

Responsabilidades

• Execute manufacturing steps and monitor against batch records, ensuring accurate documentation.
• Schedule shift tasks and allocate resources; share information during shift exchanges.
• Record and review cGMP data, update documents, and ensure real-time review of batch records.
• Provide training, coaching, and performance feedback to associates and coordinate with supervision.
• Investigate deviations and lead corrective/preventive actions; act as SME for audits.
• Serve as operational point of contact during shifts, offering guidance and troubleshooting.

Conhecimentos

Manufacturing leadership

cGMP environment

SOPs & GDP

Aseptic / cleanroom

Trackwise / DeltaV / Syncade / LIMS

Pipetting / lab techniques

Formação académica

Bachelor’s degree in STEM

Direct experience in manufacturing

Ferramentas

Trackwise

DeltaV

Syncade

LIMS

Descrição da oferta de emprego

About This Role

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: This role follows a 2-2-3 calendar rotation on days (6:00 AM – 6:00 PM ET)
• Internal Shift Details: Red Days rotating schedule

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 to cGMP, as well as 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.

What You’ll Do

• Execute manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR, and control system. Coordinates and/or leads 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. This includes production, validation, or other project activities. Also, responsible for proper information sharing at shift exchange and ensure all issues are communicated 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. Key documentation includes 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. Provide training to other associates as required and share knowledge with others. Observe performance of employees, provides timely and targeted coaching for employees, and provides feedback to the Supervisor at 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

Who You Are

You’re driven by a mission to save lives and bring a deep sense of purpose to the work you do. Biomanufacturing is complex, and you thrive in fast-paced environments where learning agility, problem-solving, and adaptability are essential.

Required Skills for Lead, Manufacturing:

$33.17 - $43.27 Pay Range

• 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
  • A BioWorks Certificate or associate's degree, STEM preferred and at minimum 4.5 year of direct experience
  • A High School Diploma (or equivalent) and at minimum of 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 purification manufacturing operations in a cGMP manufacturing environment
• Experience with Trackwise, Delta V, Syncade, LIMS, and/or similar systems
• Previous pipetting experience in a laboratory or manufacturing environment

Preferred Skills

• Prior Purification experience in a leadership capacity
• Lean, Six Sigma and 5S certifications

Job Level: Professional

Additional Information

The base compensation range for this role is: $33.17-$43.27

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.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

• 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

Why Biogen?

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. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.