Process Development Scientist-Molecular Biologist/Biotechnologist
Reports to: R&D Executive VP/CSO
Manages Others: Yes
Education: PhD with 2-3 years’, Master’s degree with 4-5 years’ experience
Related Degree Programs: Life Sciences or Biochemical Engineering/Molecular Biology
Work Experience Requirement: GMP controlled therapeutic manufacturing environment is a plus
A combination of experience and/or education will be taken into consideration
ABOUT NOVEOME BIOTHERAPEUTICS, INC.
Noveome Biotherapeutics, Inc.is a clinical stage biopharmaceutical company with an innovative platform technology that represents a paradigm shift in the development of novel therapeutics. Unlike most drugs that are single molecules/single targets, Noveome’s product is a complex mixture of biomolecules that has the ability to address a wide range of conditions and injuries. Noveome collaborates with major research centers to advance these therapeutic applications.
The Process Development Scientist-Molecular Biologist/Biotechnologist will modify primary cells to convert them to continuous or semi continuously dividing cells (extended-life, immortalized cells). This person will work closely with a biochemical engineer to scaleup these extended life cells for use in cGMP production. In addition, this person will collaborate with the R&D department to discover cells or cell lines that may be appropriate for cell-based biological assays.
What you will do for Noveome:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
- Creates an extended-life or immortalized cell that is appropriate for cGMP manufacturing of products.
- Obtains a complete understanding of the primary cells that may be used for cellular therapy.
- Works with the biochemical engineer and R&D group to develop cell manufacturing methods, including scale-up, yield optimization, and control strategies for anchorage-independent cells.
- Assists with the development of protein purification/concentration processes of complex biological solutions.
- Develops and/or assists in the development of drug delivery formulations.
- Designs, executes, and analyzes experimental results to define process variability and critical process parameters.
- Writes formal development reports for use in FDA regulatory submissions.
- Authors formal technology transfer plans for the transition of processes and methodologies to the manufacturing department.
- Maintains working understanding of Noveome manufacturing Standard Operating Procedures (SOP’s), practices, and specifications.
- Cultures and evaluates new cell line as candidates for future production.
- Assists and/or takes responsibility for troubleshooting and root cause analysis when necessary.
- Maintains proper documentation of all experimental procedures and results.
- Prepares presentations of ideas, data, conclusions, processes, and outcomes for discussion with team.
- Works closely with the manufacturing and regulatory departments to achieve company goals.
- Explores alternative methods of scalable, cell culture processes.
- Performs molecular biological assays.
- Troubleshoots ongoing manufacturing processes.
Please note, as a company rooted in innovation, our positions are consistently evolving and we champion the development of all roles. This job description is not designed to contain comprehensive listing of all responsibilities that are required, as they may change to meet the ongoing needs of the Company.
- Experience growing and maintaining primary, anchorage-dependent anchorage-independent cells
- Experience with instrumentation for assessing growth rates and quantitating the viability and health of cells
- Experience scaling-up cell culture and investigating various cell culture technologies
- Maintenance of sterile culture conditions
- Creation and evaluation of biochemical, molecular biological, cell-based and chemical assays
- Experience with or basic understanding of requirements for interdepartmental technology transfer
- Aseptic technique and proper handling of human tissue and cell specimens
- Apply appropriate statistical methods for designing experiments, analyzing and presenting data
- Working knowledge of Microsoft Office applications, graphing software, statistical software, and presentation of data
- Scientific report writing
- Keen understanding of protein biochemistry and analytical techniques
- Understanding of microbiology, virology and other adventitious agents
- Working knowledge of cellular transfections and molecular biological techniques
- Familiaritywith development and commercialization of biologic products
- Insight to proprietary approaches to research
GENERAL UNDERSTANDING OF THE FOLLOWING ANALYTICAL PROCEDURES–WORKING KNOWLEDGE OF ALL:
- Enzyme Assays
- Binding Assays
- Kd, Km
- Biochemical Assays
- Cell-based Assays
- Amino Acid Analysis
- miRNA, RNA and DNA analysis
- Microbiological Assays
- Viral Removal/Inactivation
- QC assays; e.g., osmometry, endotoxin
- Understanding of mass spectrometry, density gradient centrifugation, various forms of non-traditional analytical techniques
- Cell analysis by flow cytometry
Attributes of success:
- Critical thinking
- Detail oriented
- Proactive thinking
Work environment/physical demands
Will work in a GMP controlled chemical laboratory and clean room as well as in a business office setting. Characterized as light work that involves standing and sitting for periods of time. May require carrying, holding, lifting, pushing, and pulling up to 40 lbs. Other activities may include talking, hearing, typing, visual acuity, and writing. Will work in an environment that may have loud noises, fumes and odors that may be inhaled, works with hazardous chemicals and in close proximity of machines with moving parts.
This is an exempt, full time position with a regular schedule of Monday through Friday work hours. After an initial training period is complete a later start time may be needed to avoid conflicting equipment usage needs. Extended hours may be needed on occasion to complete company objectives.
What Noveome will do for you
Noveome provides transparency in expectations, encourages innovative thinking, opportunities for expanded learning, competitive salaries, and a clean safe work environment. Eligible employees will appreciate the comprehensive benefits package and wellness perks. Best of all you will enjoy working with colleagues at all levels in our open receptive work environment.
For consideration, please send your CV and cover letter to firstname.lastname@example.org.
Noveome, Inc. is committed to a policy of equal opportunity for all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, marital status, citizenship status, sexual orientation, disability, genetic predisposition or carrier status, military or veteran status or any other protected characteristic in accordance with applicable federal, state and local law.