Sr. Scientist, Product and Process Design – Protein

Organization
Aldevron
Job Location
Fargo
Fargo, ND 58104
Benefits

Health, Vision, Dental, Life, Long and Short Term Disability, 401k w/match, FSA/HSA, PTO

Job Description

Position Summary:

The Sr. Scientist, Product and Process Design Protein position leads activities related to the optimization of existing products/processes and implementation of new product launches and process changes to support protein manufacture.  This role leads the process of exploring and evaluating project feasibility with an emphasis on technology requirements, facility compatibility, and compliance issues. The focus of this position is on continuous improvement in terms of process, cost, quality and production of both existing and future product lines.  This position is responsible for understanding, demonstrating, and implementing Quality by Design in product and process development.

Essential Duties and Responsibilities:

  • Provide primary oversight of technical development activities with primary focus on protein manufacture
  • Develop and execute strategic plans for the PPD team in support of development of new protein product/processes, continuous improvement, testing, new equipment, new technologies and GMP manufacturing process development
  • Facilitates technology transfer from process development to BioManufacturing for new product introductions, exploring modifications of existing processes, execute process development protocols
  • Develops process documentation and training materials for new processes, materials, and equipment
  • Conducts activities related to the development of new processes, evaluating process cost, quality, and capability alternatives, and performing process under limited supervision
  • Functions as a technical role model and resource/consultant to others
  • Support of development of new product/processes, continuous improvement, testing, new equipment, new technologies and manufacturing process development.
  • Work on multiple concurrent engineering/R&D projects while ensuring success in meeting respective objectives and timelines.
  • Interface directly with clients to establish client specific manufacturing processes that will be transitioned into GMP manufacturing
  • Support continuous improvement projects addressing: process efficiency, product costs and performance
  • Support BioManufacturing in production troubleshooting and identification of root cause by conducting investigations by providing technical expertise guidance
  • Follow project plan, timeline and logistics to support new product/process launches or process changes for existing products
  • Participate in supporting transfer of technology to BioManufacturing for new products/processes from the development stage to validation with adequate transition plans to transfer knowledge
  • Support developmental and transfer activities including: research of new concepts, R&D testing, upstream and downstream process, in-process controls, scale-up, component changes and validation
  • Participate in the development and implementation of reliable methods/processes, working across functional groups to implement within the various manufacturing areas
  • Develop process/equipment SOPs and associated documents
  • Work collaboratively with Validation department to design, conduct, and develop reports for experiments to characterize and validate new or changed manufacturing processes or new equipment/technology
  • Support optimization of current processes by improving efficiency, throughput, reduce cost or increasing yield
  • Compile and maintain critical data supporting R&D, engineering and validation work
  • All employees are responsible for the general upkeep of work and shared spaces.
  • Other duties as assigned.
Requirements

Qualifications:

Experience:

  • 3+ years of working in the biotechnology industry or equivalent advanced degree
  • Broad scientific experience in proteins
  • Experience authoring standard operating procedures

Education:

  • Bachelor's degree in Molecular Biology, Biology, Biochemistry, Chemical Engineering, or related field

Skills and Knowledge:

  • Demonstrated understanding of, and prior implementation of, Quality by Design in product and process development
  • Proficient in identifying, reviewing and evaluating scientific literature to remain abreast on industry trends and new technologies for potential improved product quality or manufacturing efficiency
  • Excellent written and verbal communication skills
  • Above average organizational skills

Abilities:

  • Demonstrated ability to develop and implement technical project plans
  • Demonstrated ability to troubleshoot complex laboratory issues and resolve challenging problems
  • Ability to adapt to a changing environment and to manage multiple priorities and deadlines within a fast-paced environment
  • Ability to lead in a strategic thinking and analytical manner, with a strong ability to translate these and implement operationally
  • Ability to utilize knowledge of engineering, literature, and experience to guide decision for complex situations
  • Ability to develop investigational plans

Personal Characteristics:

  • Must be self-motivated and possess an independent work style
  • Adept at problem solving
  • Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership
  • Strategic expertise with an action oriented perspective, sound problem analysis and logical thought process

Working Conditions:

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers/filing cabinets and fax machines.

This position works in a lab setting and may come in contact with various solutions and chemicals, and will be responsible for activities related to biological processes such as bacterial growth.  This position uses standard laboratory equipment such as pipettes, centrifuges, glass ware, shake flasks, fermenters, fume hoods, and computers.  

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to see, talk and hear. The employee frequently is required to stand, walk, bend, lift up to 50 pounds, use arms, hands and fingers for various activities.  This position may stand or remain sedentary for long periods of time.  This position routinely works with large pieces of equipment.

Aldevron is a custom manufacturing organization that provides plasmid, protein and antibody development and production services. Headquartered in Fargo, ND with locations in Madison, WI and Freiburg, Germany we constantly look to innovate and advance life science through collaborative partnerships. Aldevron works with leaders in pharmaceutical, biotech and research institutions around the world to accelerate the development of drug, treatment and preventions for numerous diseases and genetic disorders. Our reputation for innovative solutions for our clients has allowed us to expand our organization and offerings in all service platforms. We are working in a landmark moment in the history of life science.

 

EEO

How to Apply

For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://www.applicantpro.com/j/500514-149639

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