Manufacturing Scientist Resume Sample
Maryjane Collier
301 Kiehn Port,
Boston,
MA
+1 (555) 423 1144
Work Experience
Senior Manufacturing Scientist
05/2018
-
PRESENT
Boston, MA
- Support of authority submissions and responses to authority requests with authoring, process expertise and data analyses
- To ensure appropriate liaison with the Development groups, Manufacturing, QA, RA, Product managers, Collaborators and Suppliers etc. so that new products
- Experience in a lab environment, preferably in a manufacturing environment; or equivalent combination of education and experience
- Monitoring, controlling, and improvement of the manufacturing processes of assigned products (continuous process verification)
- Development of consequent measures to ensure stable manufacturing processes and yield improvement
- Leading or assisting in deviation, complaint and failure investigations, product impact investigation, and root cause analysis
- Authoring of submission chapters within responsibility
- Support of submissions and responses to authorities
- Providing expert feedback to authority requests with process expertise and data analyses
Manufacturing Scientist
01/2012
-
01/2018
Philadelphia, PA
- Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems
- Support and/or lead technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity
- Participate in development and implementation of process improvements, including capital expansions and technical projects. Work within or lead cross-functional teams in positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives
- Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc
- Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps
- Develop, monitor and appropriately react to established statistically based metrics in real-time to assess process variability and capability
- Understand, justify and document the state of process validation with data that evaluate the capability of the manufacturing process to meet its stated purpose
- Provide technical support to contract manufacturers
Manufacturing Scientist Technical Services Plasma Vienna
03/2009
-
10/2011
Houston, TX
- Be part of the cross-functional manufacturing team delivering GMP manufacturing batches as required
- Become fully trained in all areas of the manufacturing process as required
- Experienced with drafting, executing, documenting and reviewing data, and approval of SOP’s and batch records according to cGMP guidelines
- 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
- Execution of small projects in accordance with agreed schedules
- Fulfilling the responsibilities of the position as defined in the Oxoid Health, Safety and Environmental policies and associated Codes of Practice
- Able to work alone, without precedent
- Actively involved in the decision process for the methods used in a project
Education
University of Wisconsin-Richland
2004 - 2008
Bachelor's Degree in Biological Science
Professional Skills
- Strong process engineering skills based on sound engineering and scientific principles
- Experience with writing validation documentation, and execution of validations
- Previous experience in roles requiring strong attention to detail
- Team player (demonstrated experience working in support of a successful project team)
- Experience in developing regulatory strategies and in interacting with regulatory authorities and official bodies (FDA, EMA, etc.)
- Experienced with manufacturing of bulk drug substance following SOP’s and batch records within a cGMP regulated environment
- Experience of working in compliance (team training, risk management, documentation, safety etc.)
How to write Manufacturing Scientist Resume
Manufacturing Scientist role is responsible for engineering, software, training, database, purchasing, manufacturing, research, modeling, travel, events.
To write great resume for manufacturing scientist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Manufacturing Scientist Resume
The section contact information is important in your manufacturing scientist resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Manufacturing Scientist Resume
The section work experience is an essential part of your manufacturing scientist resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous manufacturing scientist responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular manufacturing scientist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Manufacturing Scientist resume experience can include:
- Demonstrated understanding and experience of RCCM methods
- Able to communicate effectively, both verbally and in writing, with management and staff members
- Experience working with manufacturing equipment such as ion chambers, autoclaves, HPLC
- Experienced in participating in selecting a tactical proposal among several options based on business drivers and economic analysis
- Demonstrate application of engineering principles on individual/small projects
- Perform ongoing validation activities and change controls
Education on a Manufacturing Scientist Resume
Make sure to make education a priority on your manufacturing scientist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your manufacturing scientist experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Manufacturing Scientist Resume
When listing skills on your manufacturing scientist resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical manufacturing scientist skills:
- Excellent oral and written communication skills; organization skills; computer skills
- Excellent verbal and written communication skills; proficiency in good documentation practices essential
- Strong oral and written communication, organization, team building and computer skills essential to the role
- Good verbal and written communication skills including the ability create clear, concise written reports and accurate completion of batch records
- To maintain an awareness of company rules and working practices to ensure the work is carried out safely and effectively
- To be able to work in whichever area of Radioactive or Non Radioactive Manufacturing the job holder's skills are required and to develop production methods
List of Typical Experience For a Manufacturing Scientist Resume
1
Experience For Senior Manufacturing Scientist Resume
- Strong computer skills (MS Word, MS Excel, MS PowerPoint, Minitab)
- Demonstrates the Thermo Fisher values (4 I’s), Integrity, Intensity, Innovation, Involvement
- Excellent ability to analyze and interpret scientific, and statistical data and draw appropriate conclusions
- Contributes to the validation of all aspects of fermentation
- Fluent German and good knowledge of English
- Laboratory experience the protein biochemistry in the areas of PCR/QPCR, array hybridization, enzyme assay, and standard molecular biology
- Previous experience in chemistry, molecular biology, and/or biochemistry
2
Experience For Manufacturing Scientist Technical Services Plasma Vienna m Resume
- PhD in a scientific discipline with at least 4+ year’s relevant experience
- To use technical expertise to evaluate, in conjunction with the Production Leader the manufacturing feasibility, resource requirements and long- term
- Self-motivated and takes personal responsibility for getting the job done. Able to manage projects
- Strives for continuous improvement in their work processes
- Establishes contacts within function and wider company
- Communication is a combination of one to one within team and presentation to groups as required
3
Experience For Manufacturing Scientist Technical Services Plasma Vienna Resume
- Maintains formal laboratory records and formal internal reports
- Interacts with other departments at their own level and above
- Role is mostly practical
- Perform standard scientific assignments which are typically a significant portion of a larger project
- Select sound techniques to solve problems evaluate changes and make design recommendations under direct supervisor
4
Experience For Manufacturing Scientist / Engineer Resume
- Recommend material and process specifications
- Plan and conduct bench scale and pilot scale experiments
- Troubleshoot and solve problems at a component and system level
- Conduct failure analysis of systems, products, and parts
- Perform and maintain risk analysis and mitigation
- Knowledge of chromatography and mass spectrometry 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
5
Experience For Elanco Manufacturing Scientist Resume
- Familiarity in one or more industry standard computer languages or firmware (Lua, Python, C#, C++, etc.)
- Present research results at external conferences, publish articles in journals and/or file patents
- Provide drug product formulation and process expertise to support R&D and Supply Chain projects in development as well as to marketed products (i.e. regulatory questions, set up of manufacturing)
- PhD/MSc in Engineering, Pharmaceutics or similar
- Understand and work with complex combinations of process equipment and chemical substances processed through this equipment
- Capable of detecting technical problems and assisting the appropriate colleagues for resolution. Ability to collect and assemble applicable, vital information for presentation to CM Team Leads and/or Manufacturing Process Engineers to assist in troubleshooting and decision making
- Provides input and revises SOP’s, batch records, forms or other cGMP related documents developed or revised to support continous improvement efforts, investigation corrective actions, manufacturing operations, automation control (PLC, DeltaV, etc.) and regulatory audit commitments
6
Experience For Manufacturing Scientist Resume
- Successful manufacture of products
- On time Manufacture of Reagents
- Preparation of routine solutions and reagents
- Actively participate in the identification of processes for improvement
- Assist in the implementation of manufacturing procedures intended to optimize existing processes, such as yield, time and cost, and ensure achievement of regulatory and customer requirements
7
Experience For Senior Manufacturing Scientist Resume
- Support R&D and Tech Transfer functions in bringing new products to manufacturing
- Train on new SOPs, technologies etc to support the manufacture of new products
- Comply with applicable established cGMP, FDA, OSHA, EPA, and Quality System regulations
- Production of clinical drug product (DP) batches; directly accountable for right first time quality
- Act as a technical expert for the aseptic manufacturing process in one or more of the following areas: Grade A continuity and sterility assurance, automated filling technologies, isolator technology, VHP decontamination, lyophilization, formulation and dilution, and/or visual inspection
- Develop and update SOP’s for equipment & aseptic processes; assist area manager to provide training and activity-based competency assessments for critical activities
- Develop batch records, test protocols, and sampling plans as needed
- Perform Deviation investigations and implementation of CAPA’s
8
Experience For Manufacturing Scientist Technical Services Plasma Vienna m Resume
- Mentor less experienced staff on sterile manufacturing operations and the cGMP; help to build institutional knowledge around sterile fill/finish within Teva West Chester and the BMF
- Act as a technical resource for the area manager during internal & external audits
- Supports ongoing continuous improvement / risk assessment activities required to operate and maintain the clinical drug product facility in compliance with cGMP
- Supports operation of a non-GMP development Lab, including filling of reference standards, toxicological study material, and conduct other product development studies
- Provide expertise in the sterile manufacturing environment
- Oversee the preparation of GMP/GLP documents such as Standard Operating Procedures, Production Forms, Logbooks, and Laboratory Notebooks
9
Experience For Manufacturing Scientist Technical Services Plasma Vienna Resume
- Develop & maintain productions schedule; coordinate demand planning is Supply Chain organization
- Write, review, and approve SOP’s and other technical documents for process equipment, facilities, and manufacturing processes
- Optimise media, culture conditions, subcloning etc. to maximise product yields
- Maintain master and working cell banks for each cell line
- Assist in maintaining processes and procedures for mycoplasma and contamination control within the cell culture facility
- Ensure products manufactured are of the highest attainable level of quality
10
Experience For Manufacturing Scientist / Engineer Resume
- Assist in the technology transfer of processes to GMS and CMO sites; provide technical support for the development and introduction of novel manufacturing technologies
- Resuscitation, subculture and cryopreservation of suspension hybridoma cell lines which express monoclonal antibodies
- Work to concepts and practices of Abcam’s lab health and safety policy including the regulations governing COSHH, biological agents and genetically modified organisms
- Ensure compliance with Quality policies and SOPs
- Both practical and theoretical knowledge of the purification of plasma proteins
List of Typical Skills For a Manufacturing Scientist Resume
1
Skills For Senior Manufacturing Scientist Resume
- Plan and multitask effectively
- Set and achieve high standards for cell culture environment. Employ and encourage effective aseptic techniques and good cell culture practices
- Strong understanding of environmental monitoring requirements for the production of sterile drug products
- Knowledge/experience in working with process desing tools, e.g. Visio and statistical tools
- Business acumen, strong strategic and process thinking
- Installs and operates process equipment including fermenters, centrifuges and clean-in-place skids
- Acquire and demonstrate creative application of advanced technical and manufacturing knowledge
2
Skills For Manufacturing Scientist Technical Services Plasma Vienna m Resume
- Operate with minimal supervision of complex systems and equipment and optimizes their use in manufacturing in accordance with GMP’s
- Experience working with radioactive materials and/or radioactive isotopes
- Demonstrate the ability to write reports clearly, describing results from complex processes and qualifications
- Experienced at successfully presenting projects/proposals to management
- Hands-on production experience in aseptic processing and the manufacture of sterile drug products
- Strong knowledge of cGMP requirements and global regulatory expectations related to aseptic processing and the manufacture of sterile medicinal products
- Excellent progression opportunities with a large and growing global employer
3
Skills For Manufacturing Scientist Technical Services Plasma Vienna Resume
- Good knowledge of and appropriate compliance with guidelines as well as Shire internal requirements
- Excellent knowledge of statistics and DOE principles
- Good knowledge of risk assessment tools
- Experience with Lean or Six Sigma concepts
- BS in a scientific discipline with 0 to 2 years of relevant experience required
- Relevant experience in the GMP production environment within a pharmaceutical company
- Experience a cGMP aseptic fill finish production environment (clinical or commercial)
- Demonstrated leadership ability in a cGMP environment
- Sound knowledge of subject to interpret data and draw valid conclusions
4
Skills For Manufacturing Scientist / Engineer Resume
- Knowledge of protein purification techniques. Experience in protein process development
- Writing, maintenance and reviewing of ISO-compliant Work Instructions and Standard Operating Procedures
- Assisting and collaborating with cross functional teams in the production and testing of products as required
- Performing detailed Array Labeling and array data analysis
- Maintaining stocks of raw materials required for the manufacturing of the reagents kits
- Maintaining a work environment based on 5S and Lean Manufacturing principles
- Troubleshooting issues and leading process-related investigations and assesses technical impact of the solutions
5
Skills For Elanco Manufacturing Scientist Resume
- Working with Purchasing track, forecast and maintain stocks of raw materials required for production activities
- Performing detailed PCR/QPCR analysis
- Manufacturing in a regulated environment (ISO 13485, QSR, or similar)
- Assist with all cell culture aspects using proper aseptic techniques – feeding, freezing, thawing and harvesting
- Quick perception, analytical and abstract reasoning, solution oriented thinking, organizational talent, grasping new focus areas quickly
- Support cGMP upstream manufacturing operations by developing and conducting cGMP fermentation and/or cell culture operations
- Performs all aspects of fermentation including Media Prep, Inoculum Prep, Culturing and Harvest activities, Buffer Prep, CIP, SIP, TFF, and Sterile filtration
6
Skills For Manufacturing Scientist Resume
- Revises and updates standard operating procedures, batch records and other manufacturing documentation
- Responsible for manufacture of Cell products, Master and Working Cell Banks, and final product fills following cGMPs
- Performs the manufacturing process for the production of clinical and commercial Cell products, Master and Working Cell Banks, and final product fills
- Scientist II Manufacturing Science – Process Engineering
- To contribute to decision-making on matters relating to process improvement
- Approximately 15-25% travel to contract manufacturing sites, primarily within North America
7
Skills For Senior Manufacturing Scientist Resume
- Approximately 10-25% travel to contract manufacturing sites, primarily within North America
- Basic knowledge of manufacturing and/or biochemistry of coagulation factors
- Cope with pressure (flexibility in regard to continuous changing demands)
- Cultural awareness when dealing with customers/regulators with a different cultural background
- Profound knowledge and expertise in biochemistry, protein purification, and engineering principles
- Design robust experiments that answer the question being asked
- Basic understanding of external environment (political, economic, ecological, social, technical and legal)
- Knowledge of manufacturing and/or biochemistry of coagulation factors
8
Skills For Manufacturing Scientist Technical Services Plasma Vienna m Resume
- Authors Batch Production Records, Standard Operating Procedures (SOP’s) and Solution Preparation
- Actively assisting with the introduction of new products and the exploration of new technologies for the improvement of product quality
- Take the lead on training of new team members in both the production of products and company procedures
- Perform purification and analysis of bulk biologics using basic and advanced chromatography techniques
- Assess manufacturing processes and systems, and implement improvements aimed at performance, quality, and cost
- This is role lasting 1 year with possibility for extension
- Clear understanding of cGMPs
- Serve as the site authority on several manufacturing processes
9
Skills For Manufacturing Scientist Technical Services Plasma Vienna Resume
- Next Gen Sequencing and Target Enrichment workflows
- Hamilton, Bravo, VPrep or other automated liquid handling platforms
- Range of flexible benefits including cycle to work scheme, travel insurance, gymflex amongst others
- By maintaining an awareness of technical advances in the field of Life Science research to undertake and direct major process development projects for
- Work on several projects simultaneously and balance changing needs
- Support the site Process Monitoring, Compliance Excellence, and Continuous Improvement programs
- Update raw material inventories using SAP
10
Skills For Manufacturing Scientist / Engineer Resume
- Assist supervisor in all aspects of manufacturing processes
- Utilize software, ERP, for data entry and record keeping in conformance with company and regulatory policies and standards
- Liaise with the Drug Product Development team to facilitate technology transfer of drug products from the laboratory into the clinical manufacturing facility
- Ensure all production activities are performed following applicable cGMP’s and GSK procedures
- Coordinate the daily activities of the area supporting the manufacture of first time quality parenteral products to support development and clinical needs
- Represent Clinical Manufacturing on Supply Chain Network Delivery Teams
- Ensure compliance with cGMPs, SOPs, and GSK standards of documentation to support sterile manufacturing
- Ensure that our manufacturing process remains compliant with all applicable regulatory bodies
List of Typical Responsibilities For a Manufacturing Scientist Resume
1
Responsibilities For Senior Manufacturing Scientist Resume
- Demonstrated knowledge in Sterile / Aseptic technique required
- Use root cause analysis to develop robust solutions to technical and process manufacturing issues
- Solve problems of a technical and scientific nature
- Lead multidisciplinary teams in the execution of a project
- Work within a team environment and partner with cross-functional global matrix teams
- General laboratory and office environment where prolonged standing/walking and sitting positions are sometimes required for conducting experiments, data input, and data analysis
- Able to lift 35 - 40 lbs
- Work cross-functionally to identify short term and long term solutions to technical issues, and drive their implementation
- Advance knowledge in Microsoft Office (Word, Excel, and PowerPoint)
2
Responsibilities For Manufacturing Scientist Technical Services Plasma Vienna m Resume
- Understanding of the microbial risks to aseptic operations, and current industry best practices in technology and processes to prevent contamination of sterile drug products
- Familiarity with the concept of Grade A continuity and good aseptic techniques
- Familiarity with the complex technical equipment used in the production of sterile drug products
- Collaborate cross-functionally (operations, QA/QC, project management, development, etc) to influence peers and senior business leaders using science based data and expert knowledge of regulatory/compliance requirements
- Experience in visual inspection of parenteral products and/or buffer formulation & dilution
- Authoring technical reports supporting techincal processes, and writing standard operating procedures as they relate to the activities of the TS/MS group
- Familiarity with and commitment to continuous improvement methodology and data-driven business decision making
- Impeccable personal integrity and a commitment to transparency
3
Responsibilities For Manufacturing Scientist Technical Services Plasma Vienna Resume
- Up to 10 years’ experience a cGMP aseptic fill finish production environment (clinical or commercial), including experience in both technical operations and leadership roles
- Active participation in relevant industry organizations (ISPE, PDA, PHSS, etc)
- Knowledge of pharmaceutical pilot plant technical operations desired
- Be apart of process transfers and improvement initiatives from research and development to production facilities and from one production facility to another with addressing and anticipation of scale-up issues including: designing laboratory experiments, process improvements, and defining control strategies for processes
- Basic knowledge in the use of laboratory techniques such as chemical/buffer formulations, large and small scale protein purification, Western Blotting, sterile and aseptic techniques, pH meter, spectrophotometer buffer/media preparation
- Demonstrate knowledge in the use of basic scientific laboratory equipment such as pipettes, scales, pH meters, fume hoods, filters, CO2 incubators, BioSafety Cabinets and centrifuges
- Basic knowledge of antibody and protein production methods
4
Responsibilities For Manufacturing Scientist / Engineer Resume
- Basic knowledge in SDS-PAGE, Western Blot, basic immunological / molecular techniques
- Handle biologically hazardous materials
- VWorks automation control software
- General Molecular Biology techniques
- Provide technical expertise, experimental design, execution, interpretation, and documentation to support investigations
- Lead multifunctional teams in designing and implementing corrective actions, preventative actions, defect reduction strategies, and defect detection tools as required to resolve issues and improve test methods/manufacturing processes
5
Responsibilities For Elanco Manufacturing Scientist Resume
- Communicate investigation status reports, proposals for further investigation, etc. via oral and written reports
- Able to work in cold environment
- Knowledge and understanding of requirements for software & hardware verifications and validations, electronic signature, document control, configuration change control, good documentation practices, calibration & Preventative Maintenance as applicable to assigned tasks
- Troubleshoots, maintains and cleans bioprocess equipment and facilities
- Performs in-process assays to monitor process performance
- Adheres to GMP/GLP and SOP's
- Manufacture and test Agilent's affinity resins for the Multiple Affinity Removal Column product line
6
Responsibilities For Manufacturing Scientist Resume
- Use the Agilent HPLC platform to pack and test Multiple Affinity Removal columns
- Uncompromised dedication to quality
- As Qualified Person, required to review requests to vary the process of manufacture as a result of local events and specify any additional work required in order
- Technology, or similar qualification
- Quality and GMP knowledge
7
Responsibilities For Senior Manufacturing Scientist Resume
- The following qualifications would be optimal: Experience in Manufacturing and/or process development and/or process optimization, Green Belt certification or equivalent, laboratory experience
- Private healthcare cover
- Independently plan, execute and manage projects/programs that both span multiple disciplines and incorporate novel methods, techniques or approaches. Incorporate knowledge of customer use and product design to predict product effectiveness/anticipate potential failures. Analyze executed designs and results and modify them to increase product/processes acceptance, quality and reliability
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