Process Scientist Resume Samples

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E Wilkinson

Edmond

Wilkinson

5603 Becker Mission

Boston

+1 (555) 513 1476

5603 Becker Mission

Boston

Phone

p +1 (555) 513 1476

Experience Experience

Detroit, MI

Process Scientist

Detroit, MI

Kuphal-McCullough

Detroit, MI

Process Scientist

Using statistical tools such as JMP and MVA to analyze process performance and product quality
Mentoring/ Supervision of Associate members of the team
Participates in process and quality risk assessments
Stay current on industry trends by reading trade journals, attending trade shows, attending industry training seminars and visiting other pharmaceutical companies
Provide data/analysis to support groups including: Quality Operations, R&D, Regulatory Affairs, Microbiology, Engineering and Validation
Technical and Scientific expertise in cell culture and downstream operations for daily monitoring, troubleshooting and investigations
Performs small scale mammalian media lot screening studies to ensure successful manufacturing runs

Phoenix, AZ

R&D Process Scientist

Phoenix, AZ

Romaguera-Runolfsdottir

Phoenix, AZ

R&D Process Scientist

Work effectively in cross-functional teams
Prepare reports documenting work, operating procedures, and patent disclosures for inventions
Build a strong internal network with the Global Technology, Operations, Supply Chain, and Business teams to share best practices
Develop experimental plans using statistical tools for both experimental setup and analysis
Create seamless communication with key manufacturing personnel to optimize and/or design World Class production capabilities
Support multiple programs with expertise in mechanical testing and rheology
Design, setup, and conduct lab experiments in a safe manner, with high overall standards of EHS and housekeeping

present

Dallas, TX

Temp Process Scientist

Dallas, TX

Hoeger, Jaskolski and Harris

present

Dallas, TX

Temp Process Scientist

present

Assists in troubleshooting activities associated with the manufacturing process
Performs product impact assessments
Applies statistical process control tools in monitoring the manufacturing process
Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer
Presents process monitoring data to IOPS Management as necessary
Develops and writes protocols for manufacturing support activities
Develops and writes protocols and reports for manufacturing support activities

Education Education

Bachelor’s Degree in Biological Sciences

Indiana University

Bachelor’s Degree in Biological Sciences

Skills Skills

Strong communication and organization skills, be able to multi-task and exhibit a strong sense of urgency in order to accomplish daily tasks
Strong interpersonal skills and excellent oral and written communication skills
Knowledge in QbD principles and DOE is beneficial
Microbial and/or mammalian cell culture lab experience strongly desired
Drive process improvements. Take charge of assigned projects and be able to work with other departments to ensure completion by the deadline set
Working knowledge and hands-on operating experience with state-of-the-art purification development tools and in-process analytical methods/screening tools
Demonstrated experience and track record of success in an applicable bioprocess development/product development function in a biopharmaceutical/biotech company
Fundamental understanding and/or exposure to GMP’s desirable
Experience/exposure to preparation of CMC sections of regulatory submissions (IND/CTA’s) desirable
Ability to effectively work independently and effectively participate on multi-disciplinary teams

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15 Process Scientist resume templates

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Process Scientist Resume Examples & Samples

M.S. or Ph.D. in Biochemistry, Biology, Chemical Engineering or related sciences background with 4-7 years of industry experience. Significant experience with recombinant DNA expression platforms, bacterial strain process development, protein purification and supporting monitoring/analytical methodologies expected
Demonstrated experience and track record of success in an applicable bioprocess development/product development function in a biopharmaceutical/biotech company
Demonstrated track record of success in scale up of protein purification processes from products expressed in bacterial strains and associated analytical methodologies
Working knowledge and hands-on operating experience with state-of-the-art purification development tools and in-process analytical methods/screening tools
Experience with research/analytical methodologies such as SDS-PAGE, ELISA, HPLC, ESI-MS, AAA, DSC qPCR, LAL
Fundamental understanding and/or exposure to GMP’s desirable
Experience/exposure to preparation of CMC sections of regulatory submissions (IND/CTA’s) desirable
Ability to effectively work independently and effectively participate on multi-disciplinary teams
Strong interpersonal skills and excellent oral and written communication skills
Physical ability to lift up to 40 lbs and work at the lab bench for extended periods of time

Process Scientist Strain Dev Resume Examples & Samples

M.S. or Ph.D. in Microbiology, Biochemistry, Cell Biology, Chemical Engineering or related sciences background with 5-10 years of industry experience. Significant experience with recombinant DNA expression platforms, bacterial strain development, fermentations and supporting monitoring/analytical methodologies expected
Demonstrated track record of success in developing and improving expression constructs, bacterial strains and processes for recombinant expression of proteins and associated analytical methodologies at mid- to large-scale
Working knowledge and hands-on operating experience with state-of-the-art strain optimization and expression screening tools
Experience with research/analytical methodologies such as sequencing tools, SDS-PAGE, ELISA, HPLC
Experience preparing successful CMC sections of regulatory submissions (IND/CTA’s) desirable
Strong initiative and desire to work in a fast paced, team-oriented, dynamic environment

Process Scientist Resume Examples & Samples

Perform small scale studies to support investigations related to cell culture performance (EOF/DNF)
Work in conjunction with process data monitoring group to interpret and provide analysis with biological mechanistic perspective to understand manufacturing scale performance
Performs technical investigations and creates associated reports
Develops and writes responses for technical sections of Regulatory documents
Write protocols, summary reports, and memos for cell culture process studies
Conducts experiment at small scale via production procedures to improve the efficiency and yield of candidate or existing bioprocesses
Using statistical tools such as JMP and MVA to analyze process performance and product quality
Provides scientific insights to assist understanding of upstream cell culture process
Develops and writes protocols for small-scale process validation studies
Tabulates results and writes summary reports of process/raw material evaluation
Presents findings at group and possibly at interdepartmental meetings
Maintains lab supplies and equipment
Requires PhD in Bioengineering, chemical engineering preferred. Industrial experience with mammalian cell culture, cGMP. Computational and statistical experience strongly preferred

Msat Process Scientist Fellow Resume Examples & Samples

Recognized expert in one of the technical domain (cell-culture, protein purification, Formulated Drug Substance with linkage to Drug Product, Process Technology & Validation practices, Viral Safety)
Experience with working in a global network team
Excellent communication skills, simplify complex technical topics for communication to wide audiences
Demonstrated technical mentoring and coaching skills
Lead teams- Encourage collaboration and communication within and beyond the team

Senior Process Scientist Resume Examples & Samples

Provides technical support for Technology transfer purification activities
Performs purification investigations in the laboratory and creates associated reports
Carries out small-scale purification process validation studies
Tabulates results and writes summary reports of process evaluation and validation studies
Produces and maintains accurate records
Provides coaching and mentoring to junior members of the team
PhD in Biotechnology, Biochemistry, Chemical Engineering or a related field with 3+ years experience; may consider another discipline with added relevant experience
Candidates with an MSc Biotechnology or related field with 6+ years experience will also be considered

Senior PV Process Scientist Resume Examples & Samples

Support the GH and the Leaders of SEP in completing identified tasks and deliverables in connection with routine support provided to various teams in respect to the core PDS processes and scientific enablement
Assist in the completion of projects and new strategic initiatives by managing logistics, integrating with teams, attending meetings, and following through on assigned tasks
Triage, and organize requests for SEP support from the wider organization (PDS and other functions)
Expand the reach of the GH and the Leaders of SEP and the group’s overall effectiveness by maintaining contact/dialogue with key stakeholders (e.g. within PDS, with cross-functional teams (e.g. GDTs, LCTs) and/or working groups) already established by the SEP group and to triage and disseminate new requests to maximize SEP involvement
Contribute in the development of new tools under the leadership of the GH and the Leaders of SEP
Support the quality management of the core PDS processes under the supervision of the PV Process Leader and in collaboration with other stakeholders
Keep abreast of new developments in the core PDS processes to have proper context in support of the PV Process Leader and successful completion of assigned tasks

Process Scientist Resume Examples & Samples

Design and implement experimental studies to generate the results required to keep production moving
Review preparative methods with the laboratory team, and to confirm process operations will transfer to production at scale. Advise the project team on modifications that may simplify operations
Review draft batch sheets and use tests to confirm the planned processes and materials will deliver the expected outputs
Be a technical expert to provide solutions to common processing issues when they arise in production
Co-ordinate and gather information from the project team in the event of process failure; formulate plans to investigate and solve the problems
A degree or PhD. in Chemistry
Production and process development experience in batch chemical and/or pharmaceutical manufacture, essential
Excellent communicator with an understanding of who are the key stakeholders when problem solving
Flexible and adaptable with an open minded view and creative problem solving skills
Knowledge of GMP regulatory aspects, and pharmaceutical regulations
Demonstrated exposure to the CRO/CMO environment
Demonstrated successful planning and organizational skills
Able to work on your own and as part of a team
Excellent time management and prioritisation capabilities. Ability to successfully manage multiple tasks simultaneously
Strong sense of accountability for the outcome

Process Scientist Resume Examples & Samples

Authors Process Validation protocols and report activities
Applies statistical process control tools in monitoring the manufacturing process
Investigates OOS and OOL IPCs
Participates in process and quality risk assessments
Presents process monitoring data to IOPS Management as necessary
Assists in troubleshooting activities associated with the manufacturing process
PhD in Biotechnology, Biochemistry, or a related field with 0-2 years’ experience; may consider another discipline with added relevant experience. cGMP experience is desirable
Candidates with an MSc in Biotechnology or a related field with 3+ year’s relevant experience will also be considered

Process Scientist Resume Examples & Samples

Conducts scaled-down production procedures to improve the efficiency and yield of candidate or existing bioprocesses
Carries out small-scale process validation studies
Assists in the analysis of samples generated from lab scale studies
Requires PhD in Biology, Biomedical Sciences or Chemistry or a related field with 0-2 years’ experience; may consider another discipline with added relevant experience. Cell culture experience is preferred

Process Scientist Resume Examples & Samples

Support and lead, were applicable, programmes for the introduction & development of new products into the commercial facility
Support the process of manufacture of existing and new products
Support validation activities within the scope of Site technology
Support all aspects of a product life cycle, including development, registration, clinical and commercial manufacture
Support the Site Technology department in meeting departmental and site KPI’s
Support the various Site Technology functions including development facility and Site Technology Analytical Laboratory
The role will also support all aspects of new technology introduction, development, plant performance, process improvements, GMP & EHS compliance
Product Support
3rd level technical qualification (Chemistry, Biochemistry, Pharmacy or Chemical Engineering) to degree level and qualification to PhD desirable
1 to 3 years’ experience within a GMP manufacturing environment i.e. Pharmaceutical/Chemical/Food (exceptions may be made for candidates with suitable academic qualifications)

Process Scientist Resume Examples & Samples

Develops and writes protocols for laboratory-scale process validation and evaluation studies
Conducts scaled-down mammalian cell culture and/or antibody purification production procedures to support characterization and validation of candidate or existing bioprocesses
Collects and analyzes results and writes summary reports of laboratory-scale process validation and evaluation studies
Collates and analyzes data from development studies, process validation and characterization studies, historical process data, investigative findings and process risk assessments to develop in-process control programs for manufacturing bioprocesses
Oversees lifecycle activities of established in-process control programs for manufacturing bioprocesses, including impact assessment, change control, and document generation or revision
Provides scientific analysis of results generated from laboratory-scale studies, including determination of possible mechanisms of process behavior in cell culture and/or purification systems
Develops and writes responses for technical sections of regulatory documents
Presents findings at group and interdepartmental meetings
Knowledge in QbD principles and DOE is beneficial
Requires PhD in Chemistry, Biochemistry, Chemical Engineering or a related field with 0-2 years’ experience; may consider another discipline with added relevant experience. cGMP experience and statistical analysis/ design of experiments (DOE) experience or training is desirable

Process Scientist Resume Examples & Samples

Provides technical support for departmental projects, change controls, risk assessments, deviations, CAPA’s and audits
Provide data/analysis to support groups including: Quality Operations, R&D, Regulatory Affairs, Microbiology, Engineering and Validation
Utilize project management skills to track progress of projects to ensure milestones are met
Stay current on industry trends by reading trade journals, attending trade shows, attending industry training seminars and visiting other pharmaceutical companies
Drive process improvements. Take charge of assigned projects and be able to work with other departments to ensure completion by the deadline set
Generate an analyze trend reports on production processes and track effectiveness of changes. Communicate this information to department personnel and site management on a routine basis
Coordinates document changes utilizing DCMS
Analyzes quality indicators, including yields, microbial data, environmental monitoring, deviations, etc., evaluates information relating to process conditions and assesses their state of control
With a BS/BA in a scientific or technical discipline, 3+ years in a pharmaceutical manufacturing and/or laboratory environment
With a BS/BA in another discipline, 5+ years in a professional role within a pharmaceutical manufacturing environment

Process Scientist Resume Examples & Samples

Experience with chromatographic systems and Unicorn software
Leads purification investigations
Supports technology transfer activities
PhD in Biotechnology, Biochemistry, Biochemical Engineering or a related field with 0-2 years’ experience; may consider another discipline with added relevant experience. cGMP experience is desirable

R&D Process Scientist Resume Examples & Samples

Own and maintain a laboratory area maintaining high safety and housekeeping standards
Design, setup, and conduct lab experiments in a safe manner, with high overall standards of EHS and housekeeping
Develop experimental plans using statistical tools for both experimental setup and analysis
Support multiple programs with expertise in mechanical testing and rheology
Provide leadership of process development and optimization programs for a wide range of silicone intermediate and salable products in support of productivity, quality and new product introduction initiatives
Build a strong internal network with the Global Technology, Operations, Supply Chain, and Business teams to share best practices
Create seamless communication with key manufacturing personnel to optimize and/or design World Class production capabilities
Keep abreast of current technology advancements in material science, polymer science, testing, and other relevant technical areas
Maintain safe operations within the team and with project implementation
Conduct raw material and intermediates qualification studies
Support of manufacturing through key troubleshooting investigations, optimizations, and startups
Prepare and conduct business presentations and program reviews
Prepare reports documenting work, operating procedures, and patent disclosures for inventions
Work effectively in cross-functional teams
Strong background in material science and rheology fundamentals, with practical application experience. Hands-on experience with rheological and dynamic mechanical testing instrumentation
Demonstrated program leadership experience – proven problem solving and project executions skills
Sufficient knowledge and experience to safely setup and conduct laboratory research and testing
Proven history of creativity/ingenuity
Excellent written and verbal communication skills. Must be able to effectively communicate ideas in research, operations and commercial environments
Basic statistics and data analysis knowledge
Ability to travel overseas and to work in a chemical laboratory and chemical manufacturing plant environment
Experience using Design of Experiments principles
Six Sigma, Lean Sigma/5S, or DFSS trained
> 3 years of industrial experience

Process Scientist Resume Examples & Samples

Lead and execute validation projects to enable implementation of changes to Pre-clinical production and processing procedures
Assist development of analytical methods to advance mRNA construct analysis and production process performance
Support development, and optimization of RNA synthesis, purification methodologies
Identify automation opportunities and co-develop solutions with the integrated robotics group
Cross-functional communication with other Innovation, Development, Automation, and Analytics groups
PhD/MS in Chemistry, Engineering, Biochemistry or related discipline with 7+ (PhD) or 10+ (MS) years industrial experience
7+ years of experience developing HPLC-based purification and/or enzymatic synthesis processes in a production environment
3+ years of experience in process sciences, process development or analytical development in life science industrial role
Significant frontline experience validating process and/or analytical methods
Expertise authoring and executing validation plans and reports
Ability to work in team settings
Experience in molecular biology, NGS, molecular diagnostics or oligonucleotide production

Downstream Process Scientist Resume Examples & Samples

Ph.D required in Organic Chemistry, Biochemistry, Biology or related field (Master's degree level will be considered for candidates with significant experience)
1-5 years experience in downstream processing or biomolecule purification in an industry setting
Experience with AKTA chromatography systems including method development, troubleshooting and basic maintenance
Method development for purification of proteins using large scale process chromatography resins using FPLC or AKTA equipment
Experience in biomolecule analysis using HPLC, electrophoresis, ELISA, etc
Design downstream processing/biomolecule purification applications for chromatography resins including: Scientific literature research, project proposals and planning, execution of laboratory work, technical report writing and presentations at conferences/trade shows
Determine and discuss project plans and timelines
Technical support to clients and customers on a daily basis related to general troubleshooting issues
Review scientific data and plan further experiments which will aid Sales and Marketing groups
Maintain positive working relationships with key customer contacts
Maintain laboratory safety of all lab personnel
Maintain excellent communication within a multi-cultural environment

Process Scientist Resume Examples & Samples

1) Conduct product and process assessments, collaborate with manufacturing as well as research and development in support of drug product process development
2) Provide manufacturing input to the development teams
3) Support technology transfer from R&D to the manufacturing sites (or site-to-site transfers) using principles defined ICH, FDA, and other regulatory guidelines
4) Monitor, optimize, and troubleshoot product and manufacturing processes including lyophilization and sterile vial filling
5) Support validation activities
6) Analyze trends and criticality in product/process/equipment performance and ensure robust processes are in place and remain in a state of control after transfer to manufacturing

Process Scientist Resume Examples & Samples

1-3 years of related experience in a Pharmaceutical environment is required
Previous experience working with bioreactors in a GMP environment is a must
Hands on experience with aseptic techniques is a must
Fundamental understanding of biochemistry, cell biology, biotechnology, or chemical engineering
Microbial and/or mammalian cell culture lab experience strongly desired
Strong communication and organization skills, be able to multi-task and exhibit a strong sense of urgency in order to accomplish daily tasks

QC Process Scientist Resume Examples & Samples

Controlling and managing the irradiation sterilization processes of medical devices. Optimizing documentation, dose mapping verification, calibration of measuring equipment to comply with regulatory requirements and standards (ISO 11137 and ISO 11737)
In relation to irradiation customers; supporting development of tailored customer specific QC tests to meet requirements according to standards and USP-methods, and completing certificates of analysis
Involved in implementation and validation of software, in addition to planning and initiating of product shelf-life projects under GMP
Defining protocols and validating new tests in cooperation with R&D, QA, the Production and Product Management (ISO 13485)
Trouble shooting as part of complaint handling and non-conformances (CAPAs)
Cand. Scient. or candidate degree in biochemistry, biomedicine & technology, pharmacy or equivalent
Demonstrable competence and experience in developing and working with protocols and validation of software and processes under GMP and GDP
Working experience with ISO 11137, ISO 11737 & ISO 13485
Experience with setup and implementation of sterility tests, immunologic analysis and microbiologic tests
Motivated by improving and optimizing processes using LEAN tools
Knowledge of irradiation for sterilization and plastic surfaces is an advantage
Ability to work independently, analytically and structured, and capable of translating and communicating complex information
Committed and self-driven with a positive mindset, flexibility and persistence
Good strong communication skills in Danish and English adept with communication at all levels as well as with customers /stakeholders in a professional and effective manner

Temp Process Scientist Resume Examples & Samples

Supports all downstream activities including chromatography purification, UFDF and Form Fill
Performs scientific process investigations with relevant departments as required
Performs product impact assessments
Develops and writes protocols and reports for manufacturing support activities
Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer
Investigates Downstream OOS and OOT IPCs
Reviews and/or approves Manufacturing documentation associated with the transferred process
Mentoring/ Supervision of Associate members of the team

Process Scientist Resume Examples & Samples

Supports all Process Validation activities
Define Process Validation Strategies
Author, review and approve Process Validation protocols and reports
Schedule and support Process Validation executions
High level of technical and scientific writing required
Understand and Applies statistical tools for development of protocols and data analysis for Process Validation
Present Process Validation documents at regulatory audits
Technical and Scientific expertise in cell culture and downstream operations for daily monitoring, troubleshooting and investigations
Performs product and process impact assessments
Participates in or Lead process and quality risk assessments
Presents findings at group and at interdepartmental meetings
Communicate information on current process data which may impact Process Validation
PhD in Biotechnology, Biochemistry, or a related field with 0-2 years’ experience; may consider another discipline with added relevant experience. cGMP experience is desirable. Relevant Quality Assurance experience is desirable

Temp Process Scientist Resume Examples & Samples

Supports all upstream activities including raw materials and the process from vial thaw through harvest operations
Technical and Scientific expertise in cell culture operations for daily monitoring, troubleshooting and investigations
Provide technical floor support for Manufacturing operations
Leads cell culture investigations for the MFG operations
Leads troubleshooting activities associated with the manufacturing process
Develops and writes protocols for manufacturing support activities
Supports technology transfer activities as needed
Supports MFG Support Downstream and Process Validation activities as required

Process Scientist Resume Examples & Samples

1) The Process Scientist performs functions associated with the support of manufacturing with respect to process design space, design of experiments to further investigate process boundaries, investigate and assign parameter set-points and ranges, participate in the establishment of requirements around Materials of Construction based upon process intermediates and final product
2) In addition, this position will be responsible for executing studies in support of the assessment compliance regarding both the clearance of adventitious agents and leachables/extractables, executing work in an effort to establish and evaluate critical and non-critical process parameter set-points and ranges, process control strategy, yield and identification of process impurities
3) Participates in tracking current inventory levels of raw materials, standard and custom-designed components in support of process development efforts within a research and pilot scale operation
4) Responsible for participating in project execution which supports process change control, continuous process improvement efforts, development reports, communication of results to other contributing groups (Manufacturing, Engineering, QC, QA)
5) Participates regularly with contract research organizations with respect to scope of off-site studies, study design and details, logistics, review of draft study protocols and summary reports
BS in a Scientific Discipline and a minimum of two years of experience in development and optimization of GMP manufacturing processes or analytical/bioanalytical methods
Experience with protein purification, tangential flow filtration (TFF), sterile drug product formulation, container-closure systems, and/or packaging
Experience executing and reviewing standard operating procedures, batch records, validation protocols for equipment or process operations, execution of designed studies
Working knowledge of GMPs, ICH Guidelines on Manufacturing Process Development
Experience using DoE software such as Minitab or JMP