Manufacturing Associate (Subject Matter Expert) - Cell Culture / Upstream
Company: Biogen Idec
Location: Durham
Posted on: August 8, 2022
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Job Description:
Company DescriptionJob Description
This requisition represents multiple open positions in our RTP
Manufacturing organization. The Talent Acquisition team continually
assesses all applicants that apply through this posting and will
reach out to the selected candidates to discuss current and future
opportunities.
About This Role:
Our Manufacturing Associates perform 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 Cell Culture specifically, we perform critical upstream
processing activities within Current Good Manufacturing Practice
(cGMP) biosafety cabinets, which include:
* Mammalian cell culture & harvest:
* Work in Shake flasks, WAVE bags, centrifuges, stainless steel
bioreactors up to 15,000L
* Performing thaws and splits utilizing Aseptic technique
* Dispensing raw materials + batching of media & solutions
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 cGMP Standard Operating
Procedures (SOPs)
* Document and record all cGMP 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 (pH, Conductivity, Osmolarity, Cell Counts, 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 OR
* BioWork Certificate or Associate's Degree + at least 2.5 years of
direct and/or military experience OR
* High School Diploma (or equivalent) plus at least 3 years of
direct and/or military experience
* Foundation in targeted biopharmaceutical training strongly
preferred
* Experience executing and troubleshooting Cell Culture equipment
(bioreactors) and processes
* Ability to interpret and apply Good Manufacturing Practices (GMP)
knowledge, including documentation
* Understanding of process automation and software systems (e.g.
DeltaV, 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.
Keywords: Biogen Idec, Durham , Manufacturing Associate (Subject Matter Expert) - Cell Culture / Upstream, Other , Durham, North Carolina
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