Manufacturing Scientist Resume Samples

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E O'Conner

Emmanuelle

O'Conner

40195 Heaney Land

Detroit

+1 (555) 171 8046

40195 Heaney Land

Detroit

Phone

p +1 (555) 171 8046

Experience Experience

Dallas, TX

Manufacturing Scientist

Dallas, TX

Legros-Reinger

Dallas, TX

Manufacturing Scientist

Expected to perform both bench work and project management tasks
Plans their own work within the boundaries of a project, with the assistance of the Lead Scientist and Manufacturing Sciences Manager
Assist in developing methods and procedures to control or modify manufacturing processes
Review existing manufacturing procedures and provides technical expertise to clarify or improve procedures when necessary
May establish operation equipment specifications and improve manufacturing techniques
Identify and address initiatives to improve productivity and manufacturing process performance
May oversee the daily activities of technicians working on the assigned projects, promoting safe work practices

Detroit, MI

Manufacturing Scientist Technical Services Plasma Vienna m

Detroit, MI

Sanford, MacGyver and Stark

Detroit, MI

Manufacturing Scientist Technical Services Plasma Vienna m

Monitoring, controlling, and improvement of the manufacturing processes of assigned products
Lead or assist in deviation, complaint and failure investigations, product impact investigation, and root-cause analysis
Solid working knowledge of current GMP and ICH guidelines
Quality by Design for legacy products, update of PFMEAs, development of control strategy
Best-practice sharing with local and global teams
Product related review and approval of manufacturing and validation documents
Representation at internal and external authority audits

present

Dallas, TX

Senior Manufacturing Scientist

Dallas, TX

Shields, Willms and Green

present

Dallas, TX

Senior Manufacturing Scientist

present

Assess manufacturing processes and systems, and implement improvements aimed at performance, quality, and costs
Create, maintain, and train Technicians on work instructions and process documents
Develop and implement changes to existing documentation in a timely manner
Perform and maintain risk analysis and mitigations
Perform New Product Introduction (NPI) support on systems, sub-systems, and software
Develop protocols for process validation
Provide technical expertise and direction in multiple manufacturing areas

Education Education

Bachelor’s Degree in Chemistry

University of Illinois at Chicago

Bachelor’s Degree in Chemistry

Skills Skills

Ability to prioritize and attention to detail
Knowledge of statistical methods and applicable software
Ability to ensure equipment, plans and resources are efficiently utilized to ensure uninterrupted supply of products produced
Technical/Scientific knowledge
Good written and oral communications
Ability to operate with minimal supervision of complex systems and equipment and optimizes their use in manufacturing in accordance with GMP’s
Ability to observe technical issues and directs troubleshooting of process and equipment problems
Current knowledge of insulin products and manufacturing processes
Ability to mentor and train colleagues
Ability to Multi-task

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Senior Manufacturing Scientist Resume Examples & Samples

Troubleshoot and solve problems at a component and system level including root cause analysis
Perform New Product Introduction (NPI) support on systems, sub-systems, and software
Transition the technical aspects of NPI activities from design to manufacturing and train Technicians and Manufacturing Engineers on how to manage differences/changes
Conduct failure analysis in support of CAPA and customer issues
Review, modify, and approve ECOs for manufacturing medical device (MD) site
Create, maintain, and train Technicians on work instructions and process documents
Perform and maintain risk analysis and mitigations
Develop protocols for process validation
Maintain validation files and support any new or re-validation activities
Work with supply base and local Supplier Quality Engineering (SQE) team to ensure suppliers meet expectations and requirements and address SCARs and other corrective actions
Review and manage non-conforming material rejections from production
Design and implement test equipment as needed
BS in Engineering, Physics, Chemistry, or related discipline required, with MS/PhD in Physics or Chemistry preferred
Hands-on knowledge in design, development and engineering of complex instrumentation is required
Use of general electrical test equipment (DVM, oscilloscope, etc) and basic understanding of mechanical and electrical drawings
Strong instrumentation design and troubleshooting ability including experience in technical troubleshooting of complex instrumentation
Must be able to understand technical engineering documentation and the change control process including risk analysis review
Demonstrated ability for systematic project work
Must be a self-starter and be able to work alone and in multi-disciplinary teams
Excellent communication skills required with the flexibility to attend occasional calls outside of normal work hours
Hands-on knowledge in LC and MS hardware and software, with experience in MS and/or LC design, development and engineering is a plus
Knowledge of chromatography and mass spectrometer theory and hands-on experience with components (such as liquid chromatography, electromagnetic fields, ionization sources, mass analyzers, RF systems, electrometers, and charged particle detectors) are strong plusses
Familiarity in one or more industry standard computer languages or firmware (Lua, Python, C#, C++, etc.)/
Experience in medical device manufacturing and working in a regulated environment (ISO 9001/13485 and 21CFR820). SAP experience is a plus. Advanced knowledge of Microsoft Excel, Word, and Project required
10-15% travel to supplier and customer sites as needed
Ability to balance multiple priorities and execute with speed
Demonstrate Thermo Fisher Scientific values – Integrity, Intensity, Innovation and Involvement

Manufacturing Scientist Resume Examples & Samples

Bachelors degree in Chemistry, Biochemistry or Biology
Minimum of 5 years of industry experience, preferably in Hematology. Particle characterization is a plus. This role will support the Reagent Manufacturing on daily issues, problem solving, process improvements and validations
Statistical Data experience required. Knowledge in JMP and/or Minitab is a plus

Manufacturing Scientist / Engineer Resume Examples & Samples

Bachelor's degree in Chemistry, Microbiology, Biochemistry or related science, (or) Bachelor's degree in Chemical Engineering or related engineering discipline
Minimum of 3 years experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or related product development environment
Experience in fermentation/cell culture and/or protein purification manufacturing
Process and equipment knowledge of cell culture or purification functions
Thorough understanding of GMP requirements for a large scale manufacturing facility
Process validation experience a plus

Elanco Manufacturing Scientist Resume Examples & Samples

Serve as a technology resource to TS/MS, CMs, and R&D
Provide leadership in the product commercialization process, effectively influencing R&D, CMs, launch team, etc, ensuring the delivered manufacturing process is well understood, capable, and robust
Demonstrate ability to lead/manage complex technical projects, delivering results on time and on/under budget
Participate in Due Diligence efforts, using sound scientific and business judgment to evaluate new opportunities
Proactively develop appropriate productivity agendas
Identify areas for improvement within EEM-NA
Bachelors of Science degree or Advanced Science degree (Engineering, Chemistry, Biology, Pharmacy, and Pharma Science)
1-3 years experience in Oral Solid Dosage manufacturing and/or development
Prior relevant pharmaceutical manufacturing experience, either drug substance or drug product
Ability to handle multiple priorities and deal with ambiguity
Understanding of or experience in multiple technology platforms (small molecule, large molecule, oral solid dose, liquid formulations, etc)
Understanding of additional regulatory requirements (e.g., EPA, USDA)
Understanding of analytical methods

Manufacturing Scientist Resume Examples & Samples

Bachelor’s degree in a scientific or technical discipline (e.g., Chemistry, Biochemistry, Biology, Microbiology, Pharmacy, or Chemical Engineering)
2+ years experience in any of the following in a FDA-regulated environment - Pharmaceutical Manufacturing, Technical Services, Quality Assurance, Quality Control, or Engineering
Current knowledge of insulin products and manufacturing processes
Experience working on a process team or project team delivering improvement projects
Working knowledge of change controls and related IT systems
Good written and oral communications
Teamwork and interpersonal skills
Ability to prioritize and attention to detail
Decision making skills
Ability to Multi-task
Tasks require entering manufacturing areas which require wearing appropriate PPE. May occasionally restrict the wearing of make-up in certain manufacturing areas
Must be able to carry a cell phone and respond to issues
Potential off shift or weekend work may be required

Manufacturing Scientist Resume Examples & Samples

Bachelors of Science Degree (Engineering, Chemistry, Biology, Pharmacy)
1 year experience in manufacturing and/or development of Pre-mix products
Understanding of cGMP requirements for drug substance and drug product manufacturing
Strong problem solving skills, including strategic and creative thinking
Clear, concise communication skills (both written and verbal)
Cross-functional networking skills: demonstrated ability to influence others
Demonstrated ability to achieve results with people
Product commercialization experience
Knowledge of statistical methods and applicable software
Working knowledge of Regulus
Working knowledge of Trackwise

Senior Manufacturing Scientist Resume Examples & Samples

Provide technical expertise and direction in multiple manufacturing areas
Lead multi-department teams to support/resolve non-conforming issues for existing products
Troubleshoot calibrators, controls, and reagents as well as testing issues
Assess manufacturing processes and systems, and implement improvements aimed at performance, quality, and costs
Develop and implement changes to existing documentation in a timely manner
Degree in Biology or Chemical Science (B.S. with 5+ yrs exp, M.S. or Ph.D. with 2+ yrs exp.)
Must have strong technical background and extensive experience in the manufacture of biologicals or pharmaceuticals
Highly organized with attention to detail
Strong verbal and written communication skills

Manufacturing Scientist Resume Examples & Samples

To manufacture and purify chemical products for commercial sale by following defined established methods
Work as part of a team to support the dispense and package of products made by the group
Support team leader in manufacturing products to the time, cost and quality required, and raising any deviations from set procedures in a clear and timely manner
Utilize a variety of analytical methods in order to ensure product quality is maintained and products can be released to the customer
To provide scientific expertise and support to the manufacturing group, by gaining a thorough knowledge of the manufacturing and quality control of a range of products
Utilize problem solving skills to troubleshoot manufacturing issues including identification of root cause,
To develop and implement process improvements, using statistical and lean manufacturing principles, which will aid improvement in product quality, cost and/or growth
A BSc degree in chemistry with experience of working in a laboratory based manufacturing environment, or equivalent years working in industry or equivalent knowledge and experience
A keen interest in the manufacture of quality chemical products
Ability to communicate complex scientific information to a wide audience, and members of other business functions
Ability to work as part of a team to deliver on commitments to our customers
Understanding of manufacturing document control, defect tracking and ERP systems
Knowledge of computers and common software packages such as Word, Excel, Powerpoint
Experience of working with fluorescent molecules would be advantageous
Knowledge and experience of working with HPLC, TLC and a range of column purification techniques
Experience of working with manufacturing document control, defect tracking and ERP systems such as Oracle, Magic, MyWorkshop and Trackwise

Manufacturing Scientist Resume Examples & Samples

Identify and address initiatives to improve productivity and manufacturing process performance
Troubleshoot and solve problems at a complex system and component level including root cause analysis
Improve productivity and way of working
Represent manufacturing in development projects, co-operate with R&D, Engineering, Quality Control, manufacturing teams and other internal stakeholder
Lead, train and coach others in continuous improvement projects
Support manufacturing engineering and manufacturing teams in running of operations
Understand and perform risk analysis and mitigation
Facilitate technical communications between our Finland based and international Operations, R&D and Service&Support teams
Work closely with R&D, manufacturing engineering, sourcing and suppliers to ensure that suppliers meet technical expectations and requirements and address corrective actions
Design and implement manufacturing test methods and equipment as needed
Hands-on knowledge in LC and MS hardware and software, preferably experience of MS and/or LC engineering or instrument engineering in general
Several years of practical experience in LC/MS techniques and solutions or previous knowledge in clinical applications
Several years of experience in complex systems and technical trouble-shooting
MSc/PhD in Physics, Chemistry or Automation/System Engineering or related preferred
Analytical, data-driven problem-solving and process development skills
Understanding of (medical device) manufacturing processes
Knowledge of Lean manufacturing, Continuous Improvement and Six Sigma methods
Knowledge of Statistical Software tools (e.g. MS Excel, Minitab)
Good communication skills both in Finnish and English
Capability to network and get results in an international, multi-site environment with matrix organization structures
Willingness to travel moderately
Ambition to develop him/herself and take on wider leadership responsibilities in the future

Manufacturing Scientist Resume Examples & Samples

Bachelors in a scientific discipline or equivalent
Ability to work to very high standards, with excellent attention to detail and strong communication skills
Experience of industry standard for GMP manufacturing of biologics
Experience of methods for process scale up
Hands on experience in upstream (mammalian cell culture, HEK293), 500L Stirred tank Bioreactor, downstream processing and sterile filling
Hands on experience in the technology transfer of complex processes between teams / to different sites
Experience in liaising with third party suppliers to coordinate the supply of critical raw materials
Manufacturing experience within a cell and gene therapy environment
Several years experience working in GMP
Knowledge of GMS network

Manufacturing Scientist Resume Examples & Samples

Laboratory investigation of QNs/CAPAs
Execution of small projects in accordance with agreed schedules, work on several projects simultaneously and balance changing needs
Expected to recommend appropriate actions relating to project issues
Problem solving, fixing routine methods, interpreting unexpected results, expected to highlight solutions to problems. Some expectation for problem solving outside their own team
Influence customers (internal and external) with data to prove valid theories
Assists in the training of new staff within their team
Expected to perform both bench work and project management tasks
Plans their own work within the boundaries of a project, with the assistance of the Lead Scientist and Manufacturing Sciences Manager
Expected to handle class 2 (and 3, depending on vaccination status) microorganisms and hazardous chemicals in a safe manner, according to the department and company safety rules
The jobholder should hold a degree or equivalent in a microbiological (or related) subject
Some experience in a microbiology laboratory and as an end user of Thermo Fisher (Oxoid) products would be of benefit, but is not essential
The jobholder should demonstrate good organisational and communication skills, as well as the ability to work alone with minimal guidance

Manufacturing Scientist Resume Examples & Samples

BS/BA degree in biological science or related field
1+ years of previous experience in chemistry, molecular biology, and/or biochemistry
Hands on working knowledge of standard laboratory techniques of molecular biology (including PCR, QPCR, RNA procedures, and use of the Agilent Bioanalyzer)
Knowledge of 5S practices, GMP and continuous improvement would be a plus

Manufacturing Scientist Resume Examples & Samples

B.S. degree in science field with 2+ years’ experience or M.S. degree with 0-2 years’ experience
Excellent verbal/written communication skills
Knowledge of immunoassay/molecular assays and have commercial assay development experience in an ISO/GMP environment preferred
Six Sigma Black Belt certification desirable

Senior Manufacturing Scientist Resume Examples & Samples

Technical Product Lead (TPL) for the aducanumab process. Own Process Controls Documents for aducanuamab, partnering with drug product colleagues to ensure end-to-end technical coverage. Ensure no “drift” of manufacturing processes at different sites
Partner with MS tech transfer team to ensure success in PPQ of aducanumab at Solothurn. Consults with TT team as process and controls SME. Key team member whenever process investigations arise
Set validation strategy for aducanumab in alignment with the Regulatory filing strategy, and ensures that validation strategy carries through to new biomanufacturing cells that may be brought on-line. Writes, reviews, and /or approves relevant sections of regulatory filing documents, and supports regulatory inspections in role as aducmumab process expert (TPL)
Lead technical projects towards improved process robustness or process outputs. Partners with Manufacturing, Engineering, and QA to realize these projects. Communicate effectively to department, site leadership, and PO&T leadership as required

Manufacturing Scientist Resume Examples & Samples

Responsible for overall equipment operations and startup activities in cell culture/fermentation and bioreactor operations. Primarily focused on cell culture activities; secondary focus on small scale inoculum preparation along with other process equipment
Key responsible for new equipment startup activities
Implementation of process excellence tools to maximize production efficiency in manufacturing processes
Assist in Process troubleshooting & problem solving for the BMF Manufacturing group
Operates and maintains production equipment when needed as it relates to cell culture, Media & Buffer formulation and downstream purification processes. Including, but not limited to: equipment startup, preventative maintenance, trouble shooting, initiating work orders, etc
Experienced with drafting, executing, documenting and reviewing data, and approval of SOP’s and batch records according to cGMP guidelines
Provides detailed observations, analyzes data, and interprets results developing data formulary to generate run and campaign summary reports
Assist in investigation of deviations, helping to proposes and implement Corrective and Preventative Actions (CAPA)
Change owner for startup new production equipment, which includes but is not limited to FAT, SAT and all required validation activities documentation
Implement continuous improvement projects and quality-centered process solutions
Proposes implementation of production procedures to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success
Develops effective working relationships with both internal and external partners
Provides training to new personnel on specific technical equipment and processes
Assisting in audits from internal or external partners
Implement process procedures and equipment programs for next clinical campaign
Interface for transfer of processes to phase 3 and commercial facilities
Transparent and adheres to quality standards set by regulations and cGMP policies, procedures and mission
Communicates effectively with managers, colleagues and subordinates
Ability to participate effectively as a team player in all aspects of cGMP’s
Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meeting GMP’s strategic goals
Travels as needed
Bachelor degree with a minimum of 5 to 8 years’ experience in cGMP biopharma clinical and/or commercial manufacturing
Knowledge of cell culture process from thaw and expansion, through large scale reactors to separation technology
Experienced with manufacturing of bulk drug substance following SOP’s and batch records within a cGMP regulated environment
Knowledge of specific product-related operations in cell culture/fermentation
Ability to ensure equipment, plans and resources are efficiently utilized to ensure uninterrupted supply of products produced
Ability to mentor and train colleagues
Occasional off shift work and weekend work
1st shift and/or possible swing shift, if necessary to meet manufacturing process schedule
Lean Manufacturing experience (i.e. Six Sigma)
Preferred BS degree in Chemical Engineering, Biotechnology, Biology, Chemistry or related Engineering discipline with 3-5 years mammalian cell culture and cGMP manufacturing experience, or MS with at least 2 years’ experience in upstream mammalian cell culture and cGMP manufacturing with 2 to 3 years as a team lead or supervisor
Single use bioreactor and single use media preparation experience
Ability to observe technical issues and directs troubleshooting of process and equipment problems
Ability to operate with minimal supervision of complex systems and equipment and optimizes their use in manufacturing in accordance with GMP’s
Ability to work on complex assignments of diverse scope and ability to exercise judgment within defined procedures and practices to determine appropriate actions

Manufacturing Scientist Resume Examples & Samples

Assist with all cell culture aspects using proper aseptic techniques – feeding, thawing, and harvesting
Conduct Flow Cytometric assays
Perform cell culture tests
Inventory laboratory reagents and materials
Prepare reagents and culturing media
Perform cell isolation
Notifying immediate supervisor of any unsafe conditions and/or practices and taking appropriate corrective action
Prepare and present production reports to management regarding daily activities
Perform data entry in a conscientious manner
Follow company and department SOPs and work instructions
Bachelor’s degree in the biological sciences or related field
Knowledge of cell culture procedures and microbiological principle of contamination
Ability to perform and follow technical laboratory protocols
Capability to interact daily with the laboratory staff, including project leaders and general laboratory staff members, in coordinating daily activities
Capacity to maintain confidentiality of sensitive laboratory and business data
Strong organizational skills to plan work in a reliable and consistent manner
Communicate effectively, both verbally and in writing, with management and staff members
Basic knowledge and experience with Microsoft Word and Excel
Ability to ensure that safe laboratory procedures and protocols are followed at all times especially in the application of universal precautions in handling of all blood and blood byproducts
Ability to work as a cooperative member of the Antigen Production Group

Manufacturing Scientist Resume Examples & Samples

BS degree in a scientific field and 5-8 years of experience in a chemical or manufacturing industry, or MS and 2-4 years, or PhD and 0-2 years experience (previous experience as a chemist in a Kilo lab is ideal)
A good understanding of synthetic chemistry fundamentals, chemical transformations, and reaction mechanisms
The ability to independently perform all aspects of chemical processing of assigned projects when given manufacturing procedures
Demonstrated consistent success in project completion
Experience handling hazardous materials or equipment, and adherence to safety and manufacturing procedures is required
Must be able to communicate in a clear, concise, and diplomatic manner
Strong mechanical aptitude
Review existing manufacturing procedures and provides technical expertise to clarify or improve procedures when necessary
Complete production planning in advance of project, including raw materials inventory, ordering supplies, monitoring receipt and preparing for production
Manufacture assigned products, following standard manufacturing procedures and quality standards to meet production needs
Complete equipment set-up, operation, post production clean-up, and hazardous waste disposal
Execute, improve, or develop in-process testing as required, and work with analytical staff to meet anticipated testing needs
Assist with resolving technical issues as well as maintenance of production equipment
May establish operation equipment specifications and improve manufacturing techniques
Assist in developing methods and procedures to control or modify manufacturing processes
May oversee the daily activities of technicians working on the assigned projects, promoting safe work practices
Work with Process Development group during synthesis design, review and edit manufacturing procedures. May serve as manufacturing point person in product transfers
Train others on new manufacturing processes

Manufacturing Scientist Resume Examples & Samples

Complete product impact assessments for manufacturing deviations
Participate on project teams to provide technical guidance
Lead and facilitate problem solving teams and/or participate on teams
Lead and facilitate investigations and/or participate on investigation teams
Train manufacturing personnel on technical aspects of the process
Trend and report on yields at various forums
Spend time on the manufacturing floor to educate manufacturing operators
Propose yield budget targets
Identify improvements to the process that can reduce the product cost
Knowledge of protein purification techniques
Experience with DOE (design of experiments), six sigma, and lean manufacturing a plus
Display a solid technical understanding of biochemical principles and procedures
Strong assessment and troubleshooting skills

Manufacturing Scientist Technical Services Plasma Vienna Resume Examples & Samples

University degree in Biochemistry, Biotechnology, Biostatistics, Biology, Chemistry, Pharmaceutical Technology, or similar qualification
Experience in technical problem solving and statistical process control
Solid working knowledge of current GMP and ICH guidelines
Innovative and creative thinking
Ability to take the initiative and work independently while developing and maintaining strong communication with the stakeholders

Manufacturing Scientist Technical Services Plasma Vienna m Resume Examples & Samples

Monitoring, controlling, and improvement of the manufacturing processes of assigned products
Identification of process monitoring and yield trends and development of consequent measures to ensure stable manufacturing processes and yield improvement
Lead or assist in deviation, complaint and failure investigations, product impact investigation, and root-cause analysis
Evaluation of changes (manufacturing processes, analytical testing, and materials)
Product related review and approval of manufacturing and validation documents
Support of authority submissions and responses to authority requests with process expertise and data analyses
Quality by Design for legacy products, update of PFMEAs, development of control strategy
Representation at internal and external authority audits
Best-practice sharing with local and global teams
Excellent communication skills (written and verbal) in German and English, including experience in presenting complex topics in front of multidisciplinary audiences
DFSS certification, Black Belt preferred
Team player with excellent interpersonal skills and capability to influence and drive change agendas without formal authority