Lead, Manufacturing

NCBiotech; North Carolina; On-site; USD 46,000 - 60,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life insurance

Wellness programs

Vacation & holidays

Sick time

Parental Leave

401(k) with match

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen is seeking a Manufacturing Lead to perform and document daily operations in a cGMP environment, coordinating with the shift Supervisor and ensuring compliance. This role develops and revises batch records, SLRs, and equipment logs while acting as a process-expert for purification steps.

The ideal candidate will have a technical degree with several years in biomanufacturing, strong leadership, training, and deviations investigation experience.

Qualifications

• Four-plus years of direct biomanufacturing experience with a related degree.
• Experience in purification operations and leadership is preferred.
• Knowledge of cGMP and related documentation systems.

Responsibilities

• Executes manufacturing processing steps and monitors batch records, SLRs, and equipment logs.
• Schedules shift tasks and allocates resources; communicates issues at shift handoffs.
• Documents deviations and reviews cGMP data in real time, updating documents as needed.
• Provides training to associates and coaches employees; supports supervisory feedback cycles.
• Investigates deviations and assists in corrective/preventive actions; may serve as SME for audits.

Skills

Teamwork

Interpersonal skills

Teachability

Patience

Follow procedures

Education

Bachelor’s Degree in engineering or scientific discipline

Associate degree in engineering or scientific discipline

Certificate or HS diploma in engineering or scientific discipline

Tools

Trackwise

Delta V

LIMS

cGMP experience

Job description

Job Description

This position follows a traditional 2-2-3 format from 6a-6P ( RED Day Shift)

About This 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 to cGMP, as well as maintaining equipment and facilities. This position works closely with shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently. This is a key preparatory role for the Manufacturing Supervisor position.

The Manufacturing Lead responsibilities include but are not limited to:

• Executes 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, schedules 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.
• Documents/records and reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. Develops and/or revises documents as needed. Key documentation includes batch records, SLRs, and equipment logbooks. Ensure completeness of BPR/SLR real time review.
• Actively participates in training activities, managing their own individual training plan. Provides training to other associates as required and shares knowledge with others. Observes performance of employees, provides timely and targeted coaching for employees, and provides feedback to Supervisor mid and end of year.
• Initiates / investigates deviations, develops and implements corrective and preventative actions as required by supervisor. Leads and/or actively participates in troubleshooting. Serves as possible SME for audits.

Who You Are:

Our Small Scale Manufacturing Purification team is looking for an agile self-starter who takes accountability, is willing to learn quickly in a dynamic environment, and prioritizes accurate and ethical data recordkeeping. The incumbent is expected to be an expert on multiple unit operations, have excellent technical understanding of the processes and equipment, and is skilled at leading, scheduling tasks, training, and supporting other associates. We prioritize the possession of a few soft skills in addition to technical experience, with the opportunity for continued career development and on the job training. Key soft skills to look for are teamwork, interpersonal skills for conflict resolution, teachability, patience, and willingness to follow procedures.

Qualifications

Required Skills

• Bachelor’s Degree in an engineering or scientific discipline preferred + 4 years of direct biomanufacturing experience
• Associate degree in an engineering or scientific discipline preferred + 4.5 years of direct biomanufacturing experience
• Certificate or HS diploma in an engineering or scientific discipline preferred + 5 years of direct biomanufacturing experience

Preferred Skills

• Prior Purification experience in a leadership capacity
• Lean, Six Sigma and 5S certifications
• Experience with Trackwise, Delta V, and LIMS in addition to cGMP experience.

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, 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 DE&I efforts.

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.