Manufacturing Scientist Job Description

Manufacturing Scientist Job Description

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Manufacturing scientist provides analytical support for clinical-scale non-GMP/ GMP IND-enabling manufacturing operations, including qualification of in-process and release methods and tech transfer internally and externally in support of GMP manufacturing and release of clinical material.

Manufacturing Scientist Duties & Responsibilities

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

Sample responsibilities for this position include:

Follow GMP protocols and procedures for execution of GMP products
Support proactive process monitoring through assay and process data collection, GMP laboratory experiments (e.g., viral growth curves)
Remain current on GMP and FDA guidelines
Design, execute and report experiments related to process optimizations and process robustness studies
Implement and maintain relevant analytical methods to support the above - including acquisition of new equipment
Participate and design training of operators and supervisors
Scientific leadership of tech transfers of new manufacturing processes
Give directions to technical development teams
Lead implementation of manufacturing process control parameters, ranges and action limits
Member of Program and Tech Transfer teams for individual programs

Manufacturing Scientist Qualifications

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

Licensing or Certifications for Manufacturing Scientist

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

Education for Manufacturing Scientist

Typically a job would require a certain level of education.

Employers hiring for the manufacturing scientist 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 Manufacturing Scientist

Desired skills for manufacturing scientist include:

Analytical tools for analysis of proteins
Protein purification techniques
GMPs
Standard laboratory techniques of molecular biology
GMP
Current GMP and ICH guidelines
Manufacturing ERP systems
5S practices
Chemistry
GMP and continuous improvement would be

Desired experience for manufacturing scientist includes:

May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/Chemicals /Asbestos, confined spaces, working at heights 10 feet, temperature extremes, heavy metals, unusual work hours or routine overtime and/or inclement weather
Familiar with statistical analysis
Understanding of ISO9001 and ISO13485 requirements
Familiarity in industry standard computer languages or firmware (Lua, Python, C#, C++, )/
Experience in medical device manufacturing and working in a regulated environment (ISO 9001/13485 and 21CFR820)
Preferably minimum 2-4 years’ experience, depending on educational background, in biopharmaceutical or related field

Manufacturing Scientist Examples

1

Manufacturing Scientist Job Description

Job Description Example
Our company is hiring for a manufacturing scientist. 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 manufacturing scientist
  • Perform method development, pre-validation and validation in either biological assays or analytical chemistry
  • Work with team to ensure lean manufacturing principles are implemented and sustained
  • Work with team to help validate new equipment or processes as needed
  • Support the development and scalability of variety of molecular biology enzymes and binding proteins
  • Design and implement industrial scale manufacturing practices
  • Develop robust industrial scale purification processes for key enzymes that are used in company’s proprietary sequencing platforms
  • Work with outside vendors in the acquisition, design and implementation of large scale manufacturing equipment
  • Purify a variety of molecular biology enzymes and binding proteins to support our growing product lines
  • Participate with increasing independence on individual projects related to protein purification
  • Work as part of a scientific team and participate in team meetings and initiatives
Qualifications for manufacturing scientist
  • You have an analytic mindset
  • You have well-developed organizational skills
  • You are a good problem solver and able to prioritize your tasks effectively
  • You are comfortable to work cross-functionally in a global organization and with external partners
  • You ensure project team understanding of tasks, timely completion and follow up
  • MS in Biotechnology, or related field with 1 year of industry laboratory experience
2

Manufacturing Scientist Job Description

Job Description Example
Our growing company is looking for a manufacturing scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for manufacturing scientist
  • Write clear and concise Batch Records
  • Complete Batch Records, deviation reports and investigation reports in a timely fashion
  • Interact efficiently with Quality Assurance and Quality Control
  • Responsible for security or “isolation” of restricted areas and appropriate storage space
  • Follow responsible actions regarding chemical disposal
  • Problem solving, fixing routine methods, interpreting unexpected results, expected to highlight solutions to problems
  • Manufacture Oligo Libraries and perform test to verify product quality
  • Procedures used include (PCR, QPCR, IVT, RNA and Bioanalyzer)
  • Contribute to new product development and manufacture
  • Maintain lab areas in compliance with 5S guidelines
Qualifications for manufacturing scientist
  • Capability to absorb and utilize new knowledge quickly and drive data-based decisions
  • Experience with mammalian cell cultures and practical experience in running small scale bio-reactors
  • 5 or more years of extensive hands-on experience in purification at industrial sized manufacturing site using both non-automated and automated systems, homogenization, batch purification, precipitation, and tangential flow filtration
  • Hands on Knowledge for purifying enzymes from bacterial cell pellets at scales greater than 50 Kg of cell paste starting material
  • Thorough knowledge of the theories of protein purification, including the basis of chromatography and other downstream techniques
  • Experience working with multiple quantities of solution greater than 300 Liters
3

Manufacturing Scientist Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of manufacturing scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for manufacturing scientist
  • Carry out experiments using techniques such as, SDS-PAGE, Western blot, BiaCore, Bradford total protein, ELISA, cell-based toxin neutralization assays, MLA, and other protein related techniques
  • Work directly with scientists/engineers on study design and execution
  • Assist in authoring and preparing presentations studies, reports, SOPs, and other controlled documents
  • Analyze process/equipment data, maintain regular laboratory and system functions for the grouInterface with other on-site functional departments (Engineering, Facilities, Manufacturing, Quality)
  • Ensure compliance with cGMP and Good Documentation Practices
  • Use sound judgment to resolve problems and make routine decisions
  • Require good written and verbal communication skills, good team work skills
  • Support identification, selection, scope definition, and implementation of department capital projects
  • Order laboratory and operational supplies/materials for PD department
  • Participate in company and site-wide initiatives
Qualifications for manufacturing scientist
  • Design, conduct and maintain training for operators within the technical aspect of the processes - either by internal training or in collaboration with external partners
  • Process knowledge sharing and process problem solving within manufacturing processes
  • You are comfortable with providing training sessions
  • PhD in Biotechnology, Biochemistry, or a related field with 0-2 years’ experience
  • Associates Degree in Biology/Biotechnology required, Bachelor’s Degree in preferred
  • 2-5 years of cGMP manufacturing experience (including cell culture, aseptic processing, gowning, MVA manufacturing processes, working with bioreactors
4

Manufacturing Scientist Job Description

Job Description Example
Our growing company is looking for a manufacturing scientist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for manufacturing scientist
  • Design and execute experiments in support of process characterization, validation and continuous process improvement
  • Interfaces with other functional groups to facilitate efficient technology transfer/scale-up of production processes
  • Identify and drive technical innovations that will contribute to future business developments and improvements
  • Provide technical support for cell culture manufacturing including routine process monitoring/trending and troubleshooting of any process issues
  • Contribute to regulatory filings and provide technical leadership for agency inspections and audits
  • Author relevant sections of annual product quality reports and update process trending plans as required
  • Mentor and enhance team performance and to create a scientific climate of excellence to achieve business goals
  • Communicates project goals and updates within and across departments and provide updates on major programs to site management
  • Perform small and large scale production of mammalian cell lines to support Client and internal projects
  • Prepare media and buffers
Qualifications for manufacturing scientist
  • Experience with cGMP and ICH regulations
  • Demonstrates depth and breadth of knowledge within respective scientific discipline and recognizes interrelationships of other scientific disciplines
  • Applies in-depth scientific knowledge and skills within respective discipline to complex assignments and across other disciplines
  • Develops and implements strategies for addressing a wide variety of project needs
  • May manage junior Scientists or supervisors with primary focus on scientific output
  • Identify direction for research to be conducted
5

Manufacturing Scientist Job Description

Job Description Example
Our company is looking to fill the role of manufacturing scientist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manufacturing scientist
  • Perform standard and new operating procedures
  • Execution of complex laboratory methods
  • Perform procedures involving calculations and material measurements
  • Operating standard laboratory equipment
  • Participate in production failure investigations
  • Contribute to the overall manufacturing performance metrics (productivity, customer satisfaction and quality improvements)
  • Support activities to resolve process and testing issues
  • Conduct laboratory support functions such as stocking and distributing supplies
  • Filling, labeling and packaging of products
  • This position will have daily contact with other laboratory personnel
Qualifications for manufacturing scientist
  • Adhere to defined submission preparation timelines
  • 6+ years of experience writing regulatory submissions preferred
  • Searches document and change management databases for historical data/information that need to be
  • You have a broad, end-to-end expertise in formulation and process development for solid dosage forms, scientific and technical expertise in conventional technologies such as Direct Compression, Wet Granulation and Dry Granulation
  • We are an equal opportunity employer and value diversity at our company
  • Quick learner, open and ready to learn new skills as needed

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