Company: Emergent BioSolutions
Posted on: January 16, 2020
Those who join Emergent BioSolutions feel a sense of ownership
about their future. You will excel in an environment characterized
by respect, innovation and growth opportunities. Here, you will
join passionate professionals who advance their scientific,
technical and professional skills to develop products designed-to
The role of Bioprocess Specialist relies on previous experience and
judgment to plan and accomplish goals and perform a variety of
biopharmaceutical tasks with limited supervision. This role
requires research into new technologies and procedures for the
purposes of technical transfer and/or process improvements.
Responsibilities of primary importance are to ensure the successful
time-sensitive GMP manufacture and release of products with minimal
to zero deviations, promote a culture of quality and compliance
while driving a sense of continuous improvement and operational
excellence. This person must be capable of working both
independently and on project teams and possess strong written and
verbal communication skills. This role also requires the ability to
train those who are less experienced on topics, techniques, and
equipment for which one is considered a subject matter expert. The
Bioprocess Specialist will provide technical direction on the
manufacturing floor to other operations staff members, assist with
problem solving/troubleshooting, and escalate risk when necessary.
Other responsibilities include supporting investigations and
working with other departments to drive continuous improvements.
The Bioprocess Specialist will be responsible for planning ahead to
avoid delays, good documentation practices, and providing
leadership for the manufacturing team. Some night and weekend work
may be required.
* Identifies, plans and implements innovative technological
programs and solutions to enable the manufacture of
biopharmaceuticals in a high quality, faster and more
* Serve as a subject matter expert for biopharmaceutical
manufacturing equipment in their respective area of
* Interfaces with MSAT for process design and technical transfer
* Writes, revises and executes all types of controlled
documentation (SOP's, Production Batch Records, , etc.).
* Interfaces with Validation, Engineering, Facilities and
Operations personnel in start-up, testing and operation of new or
improved manufacturing equipment.
* Presents data/project updates to Emergent management and
* Applies lean manufacturing tools and methodologies for the
progression of process improvements (Kaizen, A3, Value Graph, Kata,
* Develops project plans including work scope, timeline and cost
estimates for process improvements
* Participate as department representative in various site/company
* Participate in site regulatory inspections as needed
* Demonstrates, understands and adheres to Emergent policies, GMP
standards and safety procedures.
* Leads/facilitates root cause investigations and/or problem
* Establish tracking and trending analyses of cGMP production
* As necessary, may assist with operational testing/qualification
of biopharmaceutical manufacturing equipment. ,
The above statements are intended to describe the general nature of
work performed by those in this job. It is not an exhaustive list
of all duties, and other duties may be assigned.
* Minimum of 8 years of pharma experience
* Bachelor's degree in Life or Physical Sciences or commensurate
* Strong knowledge based regarding the installation, operation,
cleaning and maintenance of pharmaceutical manufacturing
* Knowledgeable on application and practices of current GMP's,
international regulatory requirements and guidelines.
* Computer literate (Word, Excel and PowerPoint
Type/keyboard, visual acuity, good eye/hand coordination, stand,
walk, sit, twist/turn, climb, reach outward, reach above shoulder,
hand dexterity, bend, squat/kneel, sense of feel, sense of hearing,
sense of smell, lift/carry 10 lbs, and pull 10 lbs. Use phone, fax,
copier, and computer. Use hand tools and operate fork lift.
Organize/coordinate, analyze/interpret, calibrate precise
measurements, problem solve, make decisions, supervise, plan,
communicate, prepare written communications, and prepare
transaction documents. Drive automatic/standard vehicle. Work
outdoors, around noise above conversation level, in hot/cold
temperatures, in high humidity, where ventilation is needed, in
multiple locations, with restricted access to laboratory, in
contact with Select Agents, and with exposure to animals, animal
areas, or equipment used in animal areas.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action
Employer and does not discriminate on the basis of race, color,
religion, gender, age, national origin, disability, Protected
Veteran status, sexual orientation, or any other characteristic
protected by federal, state or local law.
Information submitted will be used by Emergent BioSolutions for
activities related to your prospective employment. Emergent
BioSolutions respects your privacy and any use of the information
Emergent BioSolutions does not accept non-solicited resumes or
candidate submittals from search/recruiting agencies not already on
Emergent BioSolutions approved agency list. Unsolicited resumes or
candidate information submitted to Emergent BioSolutions by
search/recruiting agencies not already on Emergent BioSolutions
approved agency list shall become the property of Emergent
BioSolutions and if the candidate is subsequently hired by Emergent
BioSolutions, Emergent BioSolutions shall not owe any fee to the
Keywords: Emergent BioSolutions, Lansing , Bioprocess Specialist, Other , Lansing, Michigan
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