Scientist, Manufacturing Job Description

Scientist, Manufacturing Job Description

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Scientist, manufacturing provides data modeling, mining, pattern analysis, data visualization and machine learning solutions to address manufacturing and integrated supply chain needs.

Scientist, Manufacturing Duties & Responsibilities

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

Sample responsibilities for this position include:

Develop and perform process development experiments on various blood, tissue and viral vector products
Interact with investigators or clients and provide leadership and scientific expertise in the planning, implementation and manufacturing phase of major projects
Supervise staff and resources to meet program objectives
Perform and supervises manufacturing of clinical materials (cell and viral vector products) using magnetic beads and flow cytometry technologies, bioreactors, tangential flow, chromatographic and other contemporary methods
Contribute technical expertise in support of programs/projects
Work in collaboration with senior Manufacturing, Regulatory and Quality Systems staff members
Contribute to portions of published articles or presentations
Establish or transfer in small-scale models to support manufacturing
Secure instrumentation and equipment, including APC/3X tools
Design small scale hold time and small scale mixing studies

Scientist, Manufacturing Qualifications

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

Licensing or Certifications for Scientist, Manufacturing

List any licenses or certifications required by the position: ASQ, DFSS, DMAIC, DOE, DIDOV

Education for Scientist, Manufacturing

Typically a job would require a certain level of education.

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

Skills for Scientist, Manufacturing

Desired skills for scientist, manufacturing include:

Manufacturing operations
Manufacturing operations background
Contemporary data and computing infrastructures
Contemporary machine learning
Open-source analytics tools and database structures
Paradigms and application scenarios
Pattern recognition and data-mining techniques
Process development
Variance components analysis and lean and 6-sigma approaches
Subject to interpret data and draw valid conclusions

Desired experience for scientist, manufacturing includes:

Systematically gathers information and considers broad range of issues or factors
Applies new knowledge learning’s to improve work processes
Bachelors degree in Microbiology, Biology or Chemistry
Statistical Data experience required
Scientific assessment of process related deviations
Ensure timely completion and communication of results

Scientist, Manufacturing Examples

1

Scientist, Manufacturing Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of scientist, manufacturing. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for scientist, manufacturing
  • Scientific Matter Expert for running Manufacturing campaigns
  • Reporting and interpretation of manufacturing data including trending
  • Plans and report PPQ runs
  • Support deviations/investigations with scientific assessments
  • Training of manufacturing staff and other relevant colleagues on new procedures and technologies
  • Design and execute formulation, compatibility, and process studies to support phase appropriate development of Dynavax’s drug product portfolio
  • Manage technical transfer efforts and/or manufacturing of new or existing products at CMOs
  • Manage and author appropriate development reports and other documents for internal use and support of regulatory filings
  • Formulate and manufacture bulk materials and components for the SureSelect target enrichment and support kits as well perform the required testing of each reagent, primer, and buffer, using Bait captures, PCR, and sequence analysis
  • Work with team to coordinate the manufacture and testing of samples as delivered to meet time frame set by management
Qualifications for scientist, manufacturing
  • Strong knowledge of regulatory requirements/guidance and development standards governing medical devices
  • Excellent time management skills including the ability to manage project resource requirements (material, manpower, equipment, ), and ability to elevate relevant issues to management
  • Experience in analytical testing utilizing a variety of biochemical, molecular, and cell biology techniques
  • Assist and leverage scientific knowledge in troubleshooting of technical problems that may arise
  • Help maintain stocks of raw materials required
  • Answer technical questions about products
2

Scientist, Manufacturing Job Description

Job Description Example
Our company is hiring for a scientist, manufacturing. 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, manufacturing
  • Independently formulates buffers and solutions, and prepares reagents with high complexity
  • Participates in maintaining production and laboratory equipment
  • May assist in transferring processes from development to manufacturing
  • May assist in testing raw materials for reliability and stability
  • May assist in troubleshooting issues related to reagents and/or equipment
  • May provide training to manufacturing team members
  • May serve as a point of contact for other departments for response and/or follow-up on reagent inquiries
  • Write and review characterization reports and protocols, contribute and update of Current Best Practices with respect to Continuous Manufacturing
  • Optimize the reaction processes for scale-up by making appropriate modifications of known methods or modification of reaction conditions under minimal supervision (design of new or alternate reaction sequences is not a normal expectation, but will enhance the performance evaluation of the scientist)
  • Analyze and identify compounds using a good range of modern separation and spectroscopic techniques
Qualifications for scientist, manufacturing
  • Process support to manufacturing (ex
  • Work with teams across functions (such as operators, engineers, scientists, QA ) to coordinate and align support activities, lessons learned and improvements
  • Coordination with the Global MS team to ensure global alignment
  • You have experience within purification of recombinant proteins and knowledge within mammalian Cell Culture is an advantage
  • You are a positive and open minded person
  • You thrive with teamwork
3

Scientist, Manufacturing Job Description

Job Description Example
Our innovative and growing company is hiring for a scientist, manufacturing. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for scientist, manufacturing
  • Assist in maintaining lab supplies
  • Organize, create and analyze large-scale historian and SQL data sets
  • Provide ideas and influence a growing data driven culture and gain operational experience with Big Data
  • Communicate recommendations to both Operational and IT leader
  • Collaborate with the Technical Center, Process Engineers and IT department to utilize hidden potential in the manufacturing systems
  • Identify and correct data limitations
  • Determine potential causes of problems (e.g., increases in scrap rate or test failures
  • Explain the context of multiple inter-related situations (developing multi-variate regression models), asks searching, probing questions, and solicits expert advice prior to acting and making recommendations
  • Execute experimental tasks, obtain and interpret experimental data following guidance and assignment
  • Provide oversight and hands-on execution during upstream and downstream processing, aseptic operations, sample processing, cleaning, and sterilization activities
Qualifications for scientist, manufacturing
  • Experience developing and executing cGMP documentation including Standard Operating Procedures and Batch Records
  • Experience authoring SOPs and batch records is a plus
  • Experience in all aspects of manufacturing preparation of solutions, medium, buffers, inoculum, cell banking, setup and operation of bioreactors
  • Experience maintaining fermentation, centrifugation, and filtration equipment
  • Experience with MVA manufacturing processes
  • Strong background in pharmaceutical separation science
4

Scientist, Manufacturing Job Description

Job Description Example
Our innovative and growing company is hiring for a scientist, manufacturing. 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, manufacturing
  • Behavior/Cultural Responsibilities
  • Coordinate technical aspects and functional testing for key raw material changes
  • Apply knowledge (theoretical and practical) of Cell Biology / Biotechnology or Biomedical engineering to troubleshoot or improve cell culture media, reagents and buffers
  • Identify, investigate, and develop solutions to customer issues (internal and external) in media production, and quality using data, risk analysis and experimental design
  • Participate in the harmonization and technology transfer process for the Media network to drive risk mitigation, productivity, quality and service improvements
  • Communicate with customers professionally via teleconferences, on-site visits, or customer visits around services or products
  • Contribute ideas and suggestions to improve cell culture media manufacturing processes, techniques and equipment
  • Responsible for overall equipment operations and startup activities in cell culture/fermentation and bioreactor operations
  • Operates and maintains production equipment when needed as it relates to cell culture, Media & Buffer formulation and downstream purification processes
  • Proposes implementation of production procedures to optimize manufacturing processes
Qualifications for scientist, manufacturing
  • Negotiation and resolution of customer issues
  • Anticipate optional paths for the customer to help identify alternative solutions
  • Ensure that programs stay within scope
  • Provide CMC consulting to pharmaceutical clients
  • Manage assembly of regulatory information for global CMC submissions including extraction of CMC information from regulatory databases
  • Author standard global CMC submissions
5

Scientist, Manufacturing Job Description

Job Description Example
Our innovative and growing company is hiring for a scientist, manufacturing. 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, manufacturing
  • Complete assigned tasks in a timely manner and safe manner
  • Guide other Associates in their assigned duties when needed
  • Coordinate with Supervisor and Lead to prioritize and schedule activities to meet deadlines
  • Execute equipment qualification protocols and validation protocols as required
  • Routinely draft and revise standard operating procedures and batch production records
  • Train other staff members as needed
  • Plan daily activities and schedule operations as needed
  • Participate in deviation investigations and closure
  • Manage multiple projects and initiatives concurrently to meet product process release/transfer timelines
  • Lead, plan and design experimental methods to achieve technical objectives identify and solve complex problems
Qualifications for scientist, manufacturing
  • Strong working knowledge of cell culture, protein purification, and other upstream and downstream processing techniques in a GMP environment
  • Experience working in an aseptic manufacturing environment preferred (gowning experience highly preferred)
  • Master’s degree in Chemistry and/or other related discipline
  • Bachelor’s degree in Chemistry and/or other related discipline
  • Experience with scale up and technology transfer to pilot scale and commercial manufacturing of the different manufacturing processes, including setting up DOE’s, applying scale up process modelling methodologies, mechanistically understanding the influence of the critical process parameters on the final product characteristics, statistics
  • You are able to build up a broad network within Janssen externally, academics, CRO’s

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