Sr. Manager, Manufacturing - Parenteral Filling

myGwork - LGBTQ+ Business Community; Irvine (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

An innovative biotechnology company is seeking a seasoned manufacturing leader to oversee Parenteral Filling operations. This role is crucial for fostering a collaborative environment and ensuring the successful execution of manufacturing objectives. The ideal candidate will have extensive experience in cGMP operations, particularly in leading teams within a drug product filling facility. With a focus on continuous improvement and team development, you will drive major projects, support compliance activities, and establish key performance indicators. Join a dedicated team committed to delivering life-changing medicines and making a significant impact in the biotechnology sector.

Qualifications

• 10+ years of cGMP operations experience with 5+ years in leadership roles.
• Strong understanding of cGMP requirements and exceptional communication skills.

Responsibilities

• Lead and manage drug product filling operations across multiple shifts.
• Drive continuous improvements and maintain safety-focused culture.

Skills

cGMP operations

team leadership

problem solving

communication skills

continuous improvement

Education

Bachelor’s Degree in Engineering or Life Sciences

Job description

About This Role

Biogen is seeking an experienced manufacturing leader who is responsible for establishing and maintaining accountability and ownership of Parenteral Filling operations. Fostering a collaborative working environment throughout the manufacturing area, the Sr. Manager will ensure the successful execution of Biogen’s short and long-term manufacturing objectives.

What You’ll Do

• Provide overall leadership and management of multiple direct and indirect reports (supervisors and manufacturing associates) for a drug product filling facility, operating across multiple shifts. Ensure successful delivery of short and long term manufacturing schedule through proactive scheduling and planning of activities.
• Address employee development opportunities and challenges through active coaching. Determine staffing needs and organizational structures required to efficiently meet production plans. Actively participate in hiring the best and work to develop an exceptional workforce.
• Drive major projects and programs for Biogen to completion, within schedule and budget. Evaluate, develop and implement continuous improvements and best practices for the area, including efficiency, capacity, and quality improvements.
• Actively participate and contribute to technology transfers, product launches, and implementation of process changes, typically working on cross-functional teams.
• Support cGMP compliance activities, acting as an area SME to review and approve cGMP documentation including SOPs, Batch Product Records, Change Controls, Investigations, etc.
• Develop and track area Key Performance Indicators (KPI), including identification of lead and lag metrics. Help drive overall area performance in delivery of area KPIs.
• Work to establish and maintain a safety focused culture. Proactively identify and remediate near-miss safety hazards.

Who You Are

You are a collaborative leader with technical experience in cGMP operations. You enjoy problem solving, continuous improvement and team development.

Qualifications

Required Skills

• Bachelor’s Degree (BA/BS) from a four-year college or university. (Engineering or Life Sciences preferred)
• 10+ years of direct experience in cGMP operations with a minimum of 5 years of people leadership experience within cGMP operations. Experiencing leading shop floor cGMP manufacturing teams (particularly in Parenteral Filling) is highly preferred.
• Demonstrated successful experience in leading operations in cGMP environment with a focus on team development, while building a collaborative, team-focused culture
• Comprehensive understanding of relevant cGMP requirements.
• Exceptional communication skills through all levels of an organization. Demonstrated ability to effectively operate within the sphere of control and sphere of influence.
• Ability to act independently, guided by broad area objectives.
• Ability to analyze complex problems and find common ground outcomes
• Availability to address urgent issues outside of typical work hours (i.e. weekends, holidays and non-scheduled work-days)

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.

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.