Job Description
Performs daily manufacturing coordination and support activities in accordance to Data Management, Manufacturing Support and Continuous Improvement. Responsibilities involve material handling and ordering as well as equipment coordination efforts to support manufacturing operations; batch record/documentation reviews and compilation; data mining and metric development; and manufacturing representation in cross functional projects and continuous improvement initiatives. Performs other manufacturing support functions, up to and including manufacturing operations and ownership of minor TRNs and Alert/Action level investigations, as necessary.
Responsibilities:
1- Data Management: Support/improve the overall GMP manufacturing process by ensuring that data generated through manufacturing activities is maintained, reviewed, analyzed and/or assessed.
Responsibilities may include but are not exclusive as follows: perform batch throughput analysis and product changeover throughput analysis, data integrity remediation support, lead investigation assessments, support PRIMR/batch related data entry, lead the review of executed documents to ensure compliance with cGMP, be the point of contact to assist QA & MFG teams in completing corrections for batch disposition
2- Manufacturing Support: Support/improve the overall GMP manufacturing processes by ensuring that manufacturing functions outside of general processing are completed in a timely manner and are performed consistently with the utmost quality and efficiency in order to ensure on-time and successful delivery of production schedules.
Responsibilities may include but are not exclusive as follows: Coordinate/perform product changeover and offsite equipment tracking, batch material order coordination, MFG material handling / warehouse liaison (i.e., cycle counts, inventory management), Manufacturing representation on projects and protocols, responsible for logbooks, FORMs, and other related manufacturing documents to finalize their readiness for the production team
3- Continuous Improvement: Support/lead the respective manufacturing team by partnering with OSI and Manufacturing Associates to improve manufacturing performance.
Responsibilities may include, but are not exclusive: assist respective teams in identifying areas for improvement and developing/implementing solutions; analyzing KPI's
Qualifications
- Certificate / High School diploma with 3 years direct experience working in a GMP environment.
- Associates of Arts and Science degree, education or equivalent with a minimum of 2.5-year direct experience working in a GMP environment.
- Bachelor's degree, scientific discipline preferred, with 2 years direct experience working in a GMP environment.
Additional Information
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.
