Bioprocess Specialist

Company: Emergent BioSolutions
Location: Lansing
Posted on: January 16, 2020

Job Description:

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 protect life.

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.

Responsibilites

* Identifies, plans and implements innovative technological programs and solutions to enable the manufacture of biopharmaceuticals in a high quality, faster and more cost-effective manner.

* Serve as a subject matter expert for biopharmaceutical manufacturing equipment in their respective area of responsibility

* Interfaces with MSAT for process design and technical transfer activities.

* 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 inter-departmental teams

* Applies lean manufacturing tools and methodologies for the progression of process improvements (Kaizen, A3, Value Graph, Kata, etc.)

* Develops project plans including work scope, timeline and cost estimates for process improvements

* Participate as department representative in various site/company initiatives

* 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 solving initiatives

* Establish tracking and trending analyses of cGMP production runs

* 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.

Job Requirements

* Minimum of 8 years of pharma experience

* Bachelor's degree in Life or Physical Sciences or commensurate experience.

* Strong knowledge based regarding the installation, operation, cleaning and maintenance of pharmaceutical manufacturing equipment

* Knowledgeable on application and practices of current GMP's, international regulatory requirements and guidelines.

* Computer literate (Word, Excel and PowerPoint

Physical/Mental Requirements
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 submitted will be subject to the terms of our Privacy Policy .

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 submitting agency.

Keywords: Emergent BioSolutions, Lansing , Bioprocess Specialist, Other , Lansing, Michigan