BioProcess Specialist

Location
Baltimore (Bayview), MD, US
Posted
Sep 12, 2020
Ref
667891000
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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.

JOB SUMMARY

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 direction on the manufacturing floor to other staff members, resolve issues, and escalate 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.

ESSENTIAL FUNCTIONS
  • 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.
  • Acts as a qualified trainer and is the subject matter expert for biopharmaceutical manufacturing equipment
  • Interfaces with Manufacturing Development and Process Development for tech transfer activities and process design.
  • Writes, revises and executes all types of controlled documentation (SOP's, Production Batch Records, Technical Reports, Protocols, etc.).
  • Interfaces with validation, engineering and facilities personnel in start-up, testing and operation of manufacturing equipment.
  • Presents data/project updates to Emergent management and inter-departmental teams
  • Develops project plans including work scope, timeline and cost estimates for process improvements
  • Leads in development of facility/equipment design documents
  • 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.
  • Interfaces, schedules and performs on-site monitoring of outside services of all manufacturing equipment.
  • Supports investigations and problem resolution
  • Establish tracking and trending analyses of process development, pilot and cGMP production runs
  • As necessary, may operate biopharmaceutical manufacturing equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing 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 EDUCATION, EXPERIENCE, SKILLS
  • Minimum of 8 years of biopharma experience
  • Bachelor's degree in Engineering, Life or Physical Sciences
  • Expert knowledge of the installation, operation, cleaning and maintenance of pharmaceutical manufacturing equipment
  • Knowledgeable of application and practices of current GMP's, international regulatory requirements and guidelines.
  • Computer literate (Word, Excel and PowerPoint)


PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
  • There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job.
  • This information is available upon request from the candidate.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

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.