Scientist, Process Development Job Description

Scientist, Process Development Job Description

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Scientist, process development provides continual development of mammalian cell product manufacturing processes (cell isolation, culture, cryopreservation, formulation and fill), including scale-up and control strategies.

Scientist, Process Development Duties & Responsibilities

To write an effective scientist, process development job description, begin by listing detailed duties, responsibilities and expectations. We have included scientist, process development job description templates that you can modify and use.

Sample responsibilities for this position include:

Proactively pursues and performs process development studies for the purification of therapeutic proteins
Collaborates with and provides technical support to client process development groups drives technical collaborations with the support on the internal organization
Provides technical leadership for process development related activities
Experience in method and process development
Assists with/processes pilot scale clarification and purification (equipment set up, preparation, cleaning, sample preparation, labeling, documentation)
May make contributions to scientific literature and conferences through publication and presentation of research results
Works in collaboration with the EMD Millipore sales team to prioritize projects and provide clients technical support including bench scale experimentation, consultation and training
Involvement in the selection and sizing, process optimization, technology transfer, and process validation activities associated in the purification of new biopharmaceuticals
Performs bench scale experimentation with Millipore technologies such as sterile membrane filtration, depth filtration, tangential flow filtration, viral clearance filtration, chromatography
The candidate will be highly motivated, self-directed, and able to work independently

Scientist, Process Development Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Scientist, Process Development

List any licenses or certifications required by the position: PMP

Education for Scientist, Process Development

Typically a job would require a certain level of education.

Employers hiring for the scientist, process development job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Chemistry, Chemical Engineering, Biochemistry, Engineering, Biology, Biotechnology, Science, Manufacturing, Biological Sciences, Life Sciences

Skills for Scientist, Process Development

Desired skills for scientist, process development include:

Current regulatory trends
Issues and guidelines relating to the products being supported
State-of-the art principles and theories
Cell strains
FBRM
Immortalized cell lines
Large scale
MS
Process development
Science of cell culture

Desired experience for scientist, process development includes:

Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes
Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion
Bachelor of Science in a Technical, Food Science or Engineering discipline
3 years of experience in a CPG related manufacturing or R&D field or Master of Science in a similar discipline
Intermediate (advanced preferred) understanding of statistical analysis, numerical modelling, and data analysis
Physical ability to walk throughout the plant to include multiple levels, Stand for >1 hour regularly, and >4 hours on rare occasions and lift 25 kgs

Scientist, Process Development Examples

1

Scientist, Process Development Job Description

Job Description Example
Our innovative and growing company is looking for a scientist, process development. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for scientist, process development
  • Work with project engineers production managers to provide process input for existing equipment modification, new process development and new equipment design
  • Lead multidisciplinary process development project teams
  • Experience in downstream process development – primary separations, ultrafiltration/diafiltration, chromatography resin screening, purification development and optimisation
  • Represent DSP and Process Development on interdisciplinary project teams
  • Responsible for successful process development and technology transfer of Cell and Gene Therapy products
  • Explore new technologies and identify creative solutions to improve current production and QC processes
  • Design, execute, analyze and interpret experiments
  • Lead root-cause analysis and FMEA, interface and collaborate with various development functions to solve a wide range of difficult scientific and operational problems
  • Present ongoing scientific/technical work at internal/departmental seminars and trainings
  • Collaborate with operations functions to ensure on-time, robust, and cost-effective transfer of new products into manufacturing
Qualifications for scientist, process development
  • 20 to 60% travel (domestic and international)
  • Strong diagnostic, analytical and technical ability
  • Typically requires a minimum of a Bachelor's degree in Chemistry/Material science/Chemical engineering with a minimum of 8 years relevant experience or equivalent combination of education and experience
  • Working knowledge and hands-on Experience with Immunoassay development and routine execution, HCP, rProtein A, and Insulin ELISAs
  • Ability to execute, document, and schedule activities
  • Ability to communicate effectively and follow detailed written and verbal instructions
2

Scientist, Process Development Job Description

Job Description Example
Our company is hiring for a scientist, process development. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for scientist, process development
  • Executes experiments in process development or process characterization
  • Works under the direction of scientific staff to, execute experiments in the laboratory, collect and analyse data, interpret results for the formulation and process development of new vaccine products
  • Ability to operate and maintain lab instruments such as AKTA synthesizers, purifiers and HPLC and LC-MS
  • Participates in external scientific community
  • May assume lead role in department-wide support efforts such as safety, recruiting and committees
  • May develop supervisory and mentoring skills
  • Motivate and/or supervise the activities of others
  • Develop semi-automated methods of coating chemical and biological reagents onto membranes
  • Solve problems related to fluid flow, drying processes, and membrane lamination
  • Work with scientists to evaluate process efficacy (consistency, accuracy, precision, tolerance)
Qualifications for scientist, process development
  • Ability to complete assignments in expected time frames and independently seeks out additional work when tasks are completed ahead of time
  • Ability to be troubleshoot and collaborate on complex problems to identity solutions
  • Ability to organize and prioritize own work schedule on short-term basis (shorter than one month)
  • Experience performing basic analytical techniques for protein products (HPLC analysis, protein quantification methods, electrophoresis
  • Excellent verbal and written communication skills with experience communicating both up and down the organization
  • Design, plan and schedule experiments and carry out data analysis independently
3

Scientist, Process Development Job Description

Job Description Example
Our innovative and growing company is hiring for a scientist, process development. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for scientist, process development
  • Collaborate with the analytical development teams in support of process development, to drive new analytical method development where required for process characterization
  • Supports the successful process development and technology transfer of Cell and Gene Therapy products
  • Execute high throughput process development (HTPD) experiments with BSL-1 and BSL-2 biological agents and viruses
  • Applies understanding of the scientific fundamentals of cell culture unit operations used in cell and gene therapy manufacturing to develop and justify development strategies and experimental designs
  • Responsible for trouble shooting, deviation investigation and product impact assessment for projects employing developed technology/processes
  • Designs manufacturing suite and process flow for new clients
  • Perform lab-scale downstream processing and in-process assay support for vaccine products and intermediates using standard purification techniques
  • Organizing scientific reports, tagging documents, and uploading to a new data management system while bridging documents with existing systems
  • Interacting with external manufacturing sites to work through documentation back logs
  • Participate in external scientific community
Qualifications for scientist, process development
  • Ability to understand and execute experiments independently in fulfillment of assigned program objectives in a manner that meets quality and time line expectations
  • Ability to work independently and/or in a team environment and is results oriented
  • Bachelors or Master’s Degree in Microbiology, Cell Biology, Biochemical Engineering or related field
  • Experience in fermentation and/or cell culture, including stirred tank and rocking motion bioreactors, and bioreactors for adherent cell culture
  • Familiarity with DOE strategies to develop fermentation and/or cell culture procedures suitable for cGMP production
  • Experience with data analysis using statistical tools and compiling summary reports
4

Scientist, Process Development Job Description

Job Description Example
Our company is growing rapidly and is looking for a scientist, process development. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for scientist, process development
  • Manufacture oligonucleotides, especially non-routine oligonucleotides, from synthesis to final lyophilzation step
  • Evaluate/utilize laboratory automation and purification techniques for the synthesis of oligo-biomolecules
  • Optimization and scale up of oligoneucleotide processing methods
  • Familiar with pre-clinical and IND enabling phase of the oligoneucleotide therapeutics pipeline in the industry
  • Contribute to definition of robust Phase-Appropriate processes for production and purification of personalized mRNA vaccines to enable IND-supporting activities
  • Contribute to process risk assessments, process validations, and other commercialization related activities in support of advancing through clinical development to product licensure
  • May author or co-author peer-reviewed scientific papers or patents
  • Writes detailed experimental protocols, reviews and reports data appropriately, contributes to technical reports
  • Executes and documents experimental studies, authors local Standard Operating Procedures (SOPs) and purchasing plans
  • Monitors and communicates inventory needs to the departments Materials Management group
Qualifications for scientist, process development
  • Strong technical professional in the development/optimization of manufacturing process including compounding and filling operation of sterile formulation and topical formulations
  • Familiar with different container closure systems for Injectables and Semisolids
  • Have sound knowledge of regulatory expectations, cGMP, ICH and Supac guidelines
  • Must have strong experience in aseptic technique, lyophilization and Semisolid
  • Knowledge with common analytical equipments
  • Must be able to use microsoft word, excel, power point and visio
5

Scientist, Process Development Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of scientist, process development. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for scientist, process development
  • Performs tasks for execution of routine lab studies with a high level of autonomy, and more complex studies with minimal supervisory input
  • Executes studies in accordance with study protocols
  • Individual is familiar with more than one area of discipline and can assist with study work associated with other groups under general direction
  • Separation techniques (LC, CE, iCE) and immunoassays
  • Run tests and trend assay performances
  • Work together with technicians, assistant scientists and scientists in developing new products, optimizing current products, and scaling up products/processes from laboratory to commercial scale
  • Work together with broader team consisting of technicians, assistant scientists, scientists, senior scientists, and process engineersa to achieve project portfolio objectives and deliverables
  • Conduct applied research using sound approach and sound design of experiments to achieve project objectives and deliverables
  • Experience in assay development and the experience to trouble shoot both cell based and biochemical assays across a number of detection platforms
  • A track record of on time delivery of high quality decision making data to project teams
Qualifications for scientist, process development
  • Protein chemistry and/or biochemical engineering principles
  • Providing process leadership to the big NPD projects and new line installations
  • Providing a framework for process specifications
  • Driving the IIM principles
  • Sharing technical knowledge
  • Previous coatings resin development experience

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