Location: Alabaster, Alabama
processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations – each playing a critical role in delivering our therapies to the patients who need them.
In Purification specifically, we perform critical downstream processing activities within Current Good Manufacturing Practice (c GMP) cleanroom suites, which include: Buffer Preparation Column Chromatography Viral Filtration Ultra-Filtration Bulk Dispensing of the drug substance We are seeking true Subject Matter Experts in these areas above - those who are proficient enough to work independently in their area(s) but can also be called
upon to lead in the execution of procedures and to mentor & train junior associates. What You’ll Do: Perform and be a role model for execution of daily manufacturing activities, to include operating process equipment and executing validation protocols according to c GMP Standard Operating Procedures (SOPs)Document and record all c GMP data & information (including deviations) for processing steps and equipment activities.
Create and revise key documentation like batch records, SLRs, and equipment logbooks Perform and lead in conducting in-process sampling and sampling analysis (p H, Conductivity, Protein Concentration, etc. )Help maintain a clean and safe work environment, always focusing
on audit readiness of process areas Be a team player and leader; always showing up to contribute your energy and focus Actively participate and lead in training and development initiatives, both for personal growth and for that of your team members Who You Are: You are an energetic, detail-oriented professional that loves fast-paced, high visibility work that is incredibly impactful.
Subject Matter Experts in this space know that producing clinical and commercial products in an environment like ours can be complex; so the flexibility to be adaptable is critical. Qualifications Education / Experience: Bachelor’s Degree (STEM preferred) + at least 2 years of direct and/or military experience ORBio Work Certificate or Associate’s Degree + at least 2.5 years of direct and/or military experience ORHigh School Diploma (or equivalent) plus at least 3 years of direct and/or military experience Foundation in targeted biomedical training strongly preferred Experience executing and troubleshooting Purification equipment and processes Ability to interpret and apply Good Manufacturing Practices (GMP) knowledge, including documentation Understanding of process automation and software systems (e.
g. Delta V, LIMS, etc. )Ability and desire to influence and encourage others Demonstrated experience employing learning agility Adaptable to changing needs and demands, comfortable navigating a dynamic environment Excellent communication skills (both verbal and written) throughout all levels of the organization Ability to lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds Capable of working twelve (12) hour shifts (we operate both day and night shifts) Additional Information Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team.
We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. Why Biogen? Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer.
Together, we thrive. 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 interaction, gender identity or expression, interactionual 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. This employer is a corporate member of my Gwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality. For more details: jobs-search. org/manufacturing-associate/manufacturing-associate-subject-matter-expert-purification-downstream_i1966529828
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