Process Development Scientist Resume Samples

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K Deckow

Kavon

Deckow

27004 Christa Overpass

New York

+1 (555) 855 3335

27004 Christa Overpass

New York

Phone

p +1 (555) 855 3335

Experience Experience

New York, NY

Process Development Scientist

New York, NY

Halvorson, Gibson and Langworth

New York, NY

Process Development Scientist

Data analysis, troubleshooting, and resolving a broad range of problems varying in scope and complexity
Writes laboratory documents such as Manufacturing Batch Records and Standard Operating Procedures and departmental forms
Lead scale-up of new resins from lab to manufacturing guiding process and analytical development
Technical support may involve trouble-shooting manufacturing-scale process problems through experimental investigations at laboratory scales of operation
BSc/M.Eng/MSc in biochemistry / biochemical engineering or related discipline in the biochemical/manufacturing sciences
You will support the Manufacturing team to make sure projects run according to schedule and will be delivered with excellent quality
Design and execute experimental studies for the development of vaccine manufacturing processes

Chicago, IL

Upstream Process Development Scientist

Chicago, IL

Zemlak-Stoltenberg

Chicago, IL

Upstream Process Development Scientist

Perform experiments individually or as part of a team to improve CHO and/or E. coli processes
Assist in preparing media, setting up, sterilization, sampling and cleaning of small scale bioreactors
Be responsible for following safe laboratory practices and for maintaining the work area in a clean, orderly and safe manner
Flexibility to work on a rotating weekend schedule
Assist in preparing media, setting up, sterilization, sampling, and cleaning of small scale bioreactors
Perform data analysis and share results effectively within organization
Support shake flask and small-scale cell culture process development and characterization

present

San Francisco, CA

Biologics Process Development Scientist

San Francisco, CA

Kuhic Group

present

San Francisco, CA

Biologics Process Development Scientist

present

Maintain records and test results following good manufacturing practices (GMP)
Management of lab supplies and raw materials
Perform tissue culture based experiments on live products, process intermediates, and related experimental samples
Work independently and efficiently
Document work clearly and perform tests accurately
Communicate effectively with client staff members
Lead team, schedule, and train employees in client environment

Education Education

Bachelor’s Degree in Science

University of Southern California

Bachelor’s Degree in Science

Skills Skills

Strong analytical and problem solving skills
(Analytical) Intermediate knowledge of general protein characterization assays, such as HPLC, ELISA, cIEF, SDS
(Downstream) Intermediate knowledge of cell biology, protein structure, scale up, chromatography, UF/DF and virus filtrations
(Upstream) Intermediate knowledge of cell biology, cell culture, scale up and mass transfer, bioreactor operation, disc stack centrifugation and filtration
Familiarity with large scale manufacturing and current Good Manufacturing Practices
Good at prioritizing tasks
Strong communication, technical writing, organizational and interpersonal skills
Strong computer skills (including Word, Excel, Outlook and PowerPoint)
Attention to detail and high level of accuracy
Clear and concise presentation skills

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Process Development Scientist Resume Examples & Samples

Design and execute experimental studies for the development of vaccine manufacturing processes
Initial focus will concentrate on Process Characterization and optimization of process steps for the chemical conjugation of polysaccharides and peptides to other carrier/adjuvant molecules and the optimization of purification methodologies for these large molecules
Collaborate closely with analytical scientists who will work on the characterization of these macromolecules during these process development studies
Work with team in the design and optimization of purification steps for glycoconjugates or other macromolecular vaccines using technologies such as filtration (normal/tangential flow), chromatography, etc
Provide technical support to Drug Substance Technical Services when required during investigations, new process introduction or change implementation in commercial manufacturing operations
Technical support may involve trouble-shooting manufacturing-scale process problems through experimental investigations at laboratory scales of operation
BSc/M.Eng/MSc in biochemistry / biochemical engineering or related discipline in the biochemical/manufacturing sciences
0-3+ years of directly relevant experience in the pharmaceutical industry
Technical fields of experience preferably to include specific knowledge and practical experience of large molecule bioprocessing and separation sciences including chromatography (principles/methods/materials) membrane & filtration sciences, physical chemistry of molecular interactions at interfaces, mass transfer principles, gained at a minimum at BEng or BSc level or through work experience
Additionally familiarity of chemical conjugation methods for macromolecules is also desirable
Experience in designing and executing components of experimental programs in the laboratory
Familiar with problem-solving, risk analysis and statistical tools

Process Development Scientist Resume Examples & Samples

Knowledge of inspection processes and vision systems
Knowledge of Knapp studies, inspection equipment qualifications, manual inspection qualifications and attribute agreement analysis
A third level Bachelor's degree in Science, Engineering or a relevant Quality discipline with 5 years experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience
5 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Process Characterization, Tech Transfer (to commercial DP sites) or Validation
Strong skills in applying fundamental engineering and scientific principles to the design and implementation of Inspection processes
Strong knowledge of Quality systems, Drug Product Inspection and Validation
Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skill are essential for this role

Upstream Process Development Scientist Resume Examples & Samples

Perform experiments individually or as part of a team to improve CHO and/or E. coli processes
Develop models and tools to increase scientific understanding of processes
Perform data analysis and share results effectively within organization
Manage junior staff as needed
Candidates will have background in chemical engineering, biochemical engineering, microbiology, or relevant biological sciences. A Ph.D. degree (with 0-2 yr experience) is preferred but a master’s degree (with > 2 yr experience) or a bachelor’s degree (with > 4 yr experience) may be acceptable
Technical knowledge and experience on development of CHO and/or E. coli based manufacturing processes is required
The candidate should have good skills to design experiments and analyze scientific data
He/she should have strong technical writing skills and good communication skills to share information across scientific network
He/she should be able to mentor and motivate junior personnel to accomplish scientific research
1602444

Process Development Scientist Resume Examples & Samples

Must have thorough knowledge of cGMP requirements and facilities
Hands-on expertise with scalable bio-production platforms with direct experience of upstream technologies (STR/WAVE, depth filtration/clarification, ultrafiltration/diafiltration)
Must possess good mathematics, engineering, statistical analysis and good documentation skills
Demonstrated skills in problem-solving and proposing solutions
Formal tech transfer experience in developing new processes, scaling processes, and transferring processes into operations is a must. Working knowledge of closed and single use systems highly desirable
Demonstrated ability to prioritize projects and manage time including the ability to meet deadlines
Must possess proven excellent written and oral communication skills, including experience with technical writing
Independent work skills; strong work ethic; delegating skills; ability to perform in a team setting essential for this lead position
Comfortable working in cross-functional project teams in a highly matrixed fast-paced clinical grade manufacturing organization

Upstream Process Development Scientist Resume Examples & Samples

Must have laboratory skills in basic aseptic technique, fermentation/ cell culture techniques, shake flask and bioreactor experimentation
Support shake flask and small-scale cell culture process development and characterization
Assist in preparing media, setting up, sterilization, sampling, and cleaning of small scale bioreactors
Troubleshoot equipment and performer minor repairs
Be responsible for following safe laboratory practices and for maintaining the work area in a clean, orderly and safe manner
Experience with CHO cell culture is preferred
Flexibility to work on a rotating weekend schedule
Bachelor's degree in biology, cell biology, molecular biology, or other related degree concentration
At least 1 year of industry related experience
Must be able to do weekend work on a rotating schedule

Cell Culture / Process Development Scientist Resume Examples & Samples

BSc in Biological Science or related discipline
3-5 years working in the biopharmaceutical industry
Experienced in cell culture techniques
Experience of bioreactor operation and automated cell culture techniques
Excellent technical writing skills
Ability to work independently to achieve defined goals and develop new processes
Analytical techniques such as ELISA, qPCR and virus activity and quantification
Experience of working in cell and gene therapy
Experience of working in a customer facing environment
Some understanding of downstream processes

Process Development Scientist Resume Examples & Samples

Manage and drive to completion multiple method validations at differing manufacturing sites, requiring coordination with other functions, suppliers, and/or sites
Initiate, oversee, write and update validation plans, protocols, reports and/or associated projects
Monitor identified processes and interpret data collected
Follow quality management system processes and procedures
Perform analytical methods, including but not limited to pH, conductivity, spectrophotometry, ELISA and HPLC
Interpret immunohistochemistry (IHC) staining
Data analysis, troubleshooting, and resolving a broad range of problems varying in scope and complexity
Minimum of 10 years' experience in a Clinical, Quality Control or research laboratory
PhD in a biological field
GMP/QSR/ISO background is desired
Experience with Immunoproduction, ELISA test method and validations highly preferred

Process Development Scientist With a Focus on Drug Product Development Resume Examples & Samples

Planning, execution and documentation of studies for formulation development incl. product stability
Planning, execution and documentation of studies for process development and process optimization
Supporting technology transfer and scale up activities for DP processes, as well as providing support to manufacturing
Authoring/Reviewing CMC sections for new process/product regulatory approval
Providing technical assessment on continuous process improvement initiatives and critical investigations
Serving as subject matter expert for cross-functional project teams including due diligence & integration support
Master's level degree with a (bio-) technical focus
DP formulation development experience (screening, stability, stress tests, etc.) would be ideal
Preferably DP manufacturing experience (fill/finish unit operations)
Project management skills would be highly appreciated, as well as the ability to manage complex situations and numerous stakeholders while working within an international matrix structure
Research experience, e.g. skills in design of experiments and statistics
Highly desirable qualities include solution-focus, assertiveness, professional integrity and the ability to work independently and make effective decisions
Good knowledge of English is a must; knowledge of German might make it easier to get around, but is not necessary

Process Development Scientist / Engineer Resume Examples & Samples

Responsible for independently identifying action plans to support departmental objectives
Execute action plans independently, as part of a team, or as the lead for a departmental or cross-functional teams
Independently prepare and edit procedures or technical reports of a complex nature, including data interpretation, suitable for inclusion in regulatory submissions
Develop innovative solutions to complex technical problems and leads others in problem solving efforts
Independently designs, executes, and interprets results for novel and scientifically rigorous experiments. May direct others in study execution
Maintains laboratory and clinical manufacturing facilities in accordance with procedure
Provides and/or supervises support for developmental studies, clinical or commercial manufacturing as needed
Must demonstrate strong interpersonal skills and the ability to integrate into a cross-functional team based organization
Ability to set and meet deadlines, multitask, and prioritize personal tasks based on project needs
Must have excellent written communication and strong oral communication skills
Creative and forward-thinking
Has ability to apply scientific or engineering principles, established cGMP techniques, and company’s policies and procedures in completion of job tasks
Has extensive knowledge and takes initiative in keeping current in professional area of specialization(e.g., fractionation, purification, formulation, filling, lyophilization, process analysis) and expanding knowledge base in professional area
Must be proficient in use MS Office Suite

Senior Associate Process Development Scientist Resume Examples & Samples

Execute action plans independently or as part of departmental or cross-functional team
Communicate functional area and departmental results in cross-functional settings
Independently designs, executes, and interprets results for novel and scientifically rigorous experiments
Supports the execution of start-up and commissioning of equipment and processes
During technical transfer, provides technical review of design documents for assigned systems
Provides support for developmental studies, clinical or commercial manufacturing as needed
Identifies, implements, and qualifies, as necessary, equipment to achieve operational needs in compliance with regulatory expectations
Willingness to take initiative with multiple tasks and collaborations
Takes initiative in keeping current in area of specialization (e.g., fractionation, purification, formulation, filling, lyophilization, process analysis) and expanding knowledge base in professional area
Good documentation skills

Principal Process Development Scientist Resume Examples & Samples

Implement, document and manage processes required to (a) reliably and routine produce and characterize components of the sequencing platform, including the writing of batch records, work instructions and QC test methods
Develop analytical methods for the reagents and protein characterization that will correlate with performance on our sequencing platform. These methods will include analytical HPLC, activity assays (e.g. fluorescent DNA polymerase assays) and physical characterization such as Dynamic Light Scattering
Creatively design and execute accelerated stability protocols for reagents and proteins, in light of the thermal lability of some of the components
Potentially management of junior staff

Process Development Scientist Resume Examples & Samples

Identify, create and validate new protocols, new tools, and new/improved methods related to antibody production. This includes communication with external resources and internal multi-disciplinary teams
Participate or lead projects for large scale antibody production which includes design and execution of experiments, writing report and SOPs, and transfer of process to manufacturing
Conduct trouble-shooting and root cause analysis to support manufacturing groups. Provide guidance and technical training as needed
Initiate, plan, and execute experiments, summarize projects and transfer/implement processes
Clear and concise presentation skills
PhD with > 3 years of experience OR MS with > 5 years of experience OR BA/BS with > 7 years of experience
Previous experience in life science or biotech industry in the field of antibody production
Familiarity with ISO 9001/ ISO13485, QSR’s or GMP compliance requirements
Expertise in various scales and methods of antibody production and purification in product development and process development, utilizing different chromatography methods
Extensive experience in various tools to assess protein, characterization, purity and quantity
Must be a motivated team player with attention to details, strong problem solving and communication
DoE experience is a plus
Must be able to work independently with minimal supervision and to communicate results/concerns and follow up activities promptly but be able to accept direction

Process Development Scientist Resume Examples & Samples

Lead scale-up of new resins from lab to manufacturing guiding process and analytical development
Work with project engineers as well as production managers to provide process input for existing equipment modification, new process development and new equipment design
Advise and ensure implementation of new technical know-how to achieve optimum resin production
Bring a fundamental understanding of traditional resin material and resin processes focusing on polyester polyols for coatings applications and develop new innovative processes for making these products
Apply statistical methods to understand and control process variables and product attributes
Lead multidisciplinary process development project teams. Guide and interact with lab staff, manufacturing and business personnel in implementing new products and processes in production
10 years’ experience in resin synthesis and process development for resin manufacturing
Previous coatings resin development experience. Experience with polyester resins is preferred
Strong working knowledge of resin synthesis at a lab, pilot and manufacturing scale. A significant demonstrated track-record of new product launches is preferred
Basic understanding of a broad range of analytical techniques, including rheology, thermal analysis, and various chromatography and spectroscopies. Experience in polymer characterization. A knowledge of current, on-line analytical procedures is preferred
Leadership experience in implementing process and equipment changes. A track record of innovation demonstrated through business results, patents, publications and/or industry awards is preferred
Ability to engage across multiple organization including R&D, manufacturing and business organization. Independent and driven individual with the ability to prioritize and handle multiple projects simultaneously with a focus on results
Strong interpersonal and communication skills. The ability to successful challenge the status quo and influence teams is preferred

Process Development Scientist Resume Examples & Samples

Provide technical support for the manufacturing of pharmaceutical and nutritional dosage forms. This involves planning, organizing, and executing technical projects as well as the statistical analysis of production data
Work with Research and Development to determine which market innovations can be implemented in Myerstown
Participate in long range business analyses and planning as needed
Effectively communicate, explain, and recommend to colleagues and management the results of designs, studies, and/or projects/
Troubleshoot production problems, identify the problem and recommend solutions
Carry-out scale-up of new products
Act as the interface between Product Development, Production and Quality Assurance
Develop Validation/Qualification protocols; Conduct Validation and issue Validation reports
Develop new and improved manufacturing processes for current products (to improve product quality, output and generate cost savings)
Implement effective control strategies within the manufacturing environment
Bachelor’s degree in Pharmaceutical Science, Industrial Pharmacy, Pharmacy, Chemical Engineering, or Chemistry with 4 - 6 years of pharmaceutical product development experience; or Master’s degree and 2 years of experience as noted above. The years of experience may be waved for degree programs focused on providing industry relevant experience (Pharmaceutical Science or Industrial Pharmacy Degrees)
Excellent understanding of the unit operations associated with the manufacture of solid and liquid pharmaceutical dosage forms
Experience with statistical process control
Ability to understand the scientific aspects of company's activities and apply that knowledge to the company's goals
Explain and recommend to all levels of personnel the results of projects,
Flexibility to work in a team-oriented or independent environment depending on project needs
Experience with Microsoft Office software and statistical analysis

Fill Finish Process Development Scientist AS Resume Examples & Samples

Educational requirements include a PhD or EngD in chemical, biochemical, pharmaceutical or mechanical engineering, chemistry, biochemistry, or a related engineering or pharmaceutical science field
Candidates with BSc and/or MSc in the above subjects are expected to have extensive relevant industrial experience to be considered
Biopharmaceutical drug product development
Fill-finish unit operations including formulation, mixing, filtration, fill and lyophilisation
Biopharmaceutical degradation pathways and mechanisms
QbD, experimental design, statistics, modeling
CGMP, aseptic processing , and related regulatory literature

Process Development Scientist Resume Examples & Samples

Master's or PhD in biology, biochemistry, chemistry or related scientific field and/ or combination of education
3+ years of relevant industry experience
Adept at independently identifying, developing, and implementing scientific solutions to practical problems
Strong technical background and experience with protein purification, cell culture, transfection, bioreactor processing, as well as standard lab techniques including but not limited to IHC, SDS-PAGE, ELISA, HPLC
Highly skilled at drafting SOPs and validation reports
Experience with quality management including risk assessment and change controls
Knowledge of regulations related to biologics manufacturing and testing
Must work well within a fast paced, dynamic and team oriented environment
Possess excellent organizational, communication, and problem solving skills
Good writing and presentation skills

Associate Process Development Scientist Resume Examples & Samples

1．Plan, develop, and conduct upstream cell culture project from lab scale process development to large scale production in 200L bioreactor or larger
2．Perform experimental activities with Wave /Xcellerex bioreactor and culture media to support the success of GEHC LS cell culture business, including bioreactor and media
3． Deliver Fast Trak technical on-going cell culture related training courses with the same global standard to add the value of GE products. Understand and satisfy the customers’ training needs through in-class training and the follow-up actions after training
4． Analyze and evaluate the experimental data and results; and prepare scientific publications based on these data and results
5． Prepare presentation material for sales; present at scientific conference and/or in front of customers as needed
6． Support sales activities in house and/or at the customer sites
7． Able and willing to travel up to 20% of the time
8． Understand marketing trends to support sales department and customers with expert advice. Work closely with field application specialists and support customers by offering trouble-shoots, bioprocess development services and consulting

Senior Process Development Scientist Resume Examples & Samples

Process development/ improvement/optimization initiatives and creative solutions for Liquid and Lyo Injectables and Semisolid dosage forms
Coordination between R&D and manufacturing/ contract manufacturing organizations (CMO)
Prepare process flow diagrams
Prepare Protocols and execute Engineering batches and process verification batches
Conduct Small to pilot scale batch trials with “Quality by Design” approach
Scale up formulations processes from bench scale to clinical or exhibit batch scale, which can successfully be further scaled up to commercial batch scale
Execute and oversee technical transfers, scale up and clinical manufacture at internal and external drug-product GMP facilities
Support with Launch batches and Validation Batches
Prepare Product Development report based on “QbD” guidelines and other required documents
Prepare ppt presentation before and after execution of trials
Any other task as assigned

Process Development Scientist Resume Examples & Samples

Perform lab-scale downstream processing and in-process assay support for vaccine products and intermediates using standard purification techniques (e.g. depth filtration, centrifugation, sonication, etc)
Perform lab-scale upstream processing and in-process assay support for vaccine products and intermediates
General laboratory skills, including experience with pipettes
Experience using formulas and linking spreadsheets in Excel
Bachelor's degree in Chemical Engineering, Biomedical Engineering, or Biological Sciences, preferably Biology, Biochemistry, Chemistry, or related science

Recombinant Antibody Process Development Scientist Resume Examples & Samples

Generating stable cell lines for recombinant antibody expression
Collaborate with other scientist in the group to improve the yield of recombinant antibody expression in both transient and stable expression systems
Keep good written and electronic records related to cell line development to support recombinant antibody manufacturing and process improvement
Interface with manufacturing groups to provide on-time and accurate material transfer support
Analyze results of data and prepare recommendations for improvement or trouble shooting
MS or PhD in Biochemistry, molecular biology, bioengineering or related Biological Science area, with minimum 5 years of industry experience focusing on transient and/or cell line development for recombinant antibody expression and production
Excellent communication skills are required
Extensive experience with media optimization and scaling-up of bioreactor processes is required
Familiarity with ISO 9001/ ISO13485, GLP or GMP compliance is a plus
Project management experience is desired

Process Development Scientist Resume Examples & Samples

Responsible for the execution of routine and complex laboratory studies or associated assay support with a high level of autonomy. The individual is expected to be a subject matter expert in at least one aspect of the role (USP, DSP, Analytics). This individual may provide supervision to employees
Performs tasks for execution of routine and complex lab studies (ordering, reagent prep, protocol/report writing, intermediate data analysis, documentation review, customer consults, etc)
Maintains equipment in accordance with SOPs
Participates in shared activities associated with lab housekeeping
Participates in regular safety audits and area 6S activities
Represents MSAT in both internal and external meetings
Attention to detail and high level of accuracy
Good at prioritizing tasks
Familiarity with large scale manufacturing and current Good Manufacturing Practices
(Upstream) Intermediate knowledge of cell biology, cell culture, scale up and mass transfer, bioreactor operation, disc stack centrifugation and filtration
(Downstream) Intermediate knowledge of cell biology, protein structure, scale up, chromatography, UF/DF and virus filtrations
(Analytical) Intermediate knowledge of general protein characterization assays, such as HPLC, ELISA, cIEF, SDS
Must have Purification (DSP) laboratory experience
Must have experience performing lab scale chromatography, UF/DF, Virus Filtration and Stability studies
Experience working with AKTA Explorer, AKTA Avant and Unicorn Software strongly preferred
Experience performing process characterization studies
Experience using statistical methods to design experiments (DoE) and analyze study results (ANOVA, regression, etc)

Process Development Scientist Resume Examples & Samples

Collaborates with the Development group for the transfer of new laboratory assays to Laboratory Operations, Manufacturing, and Quality Control
Evaluates developmental processes for scalability and optimization in Manufacturing and Laboratory Operations
Participates in the assay verification and validation stages of the Design Control process
Provides product support for existing laboratory assays
Presents experimental data in group/department setting
Writes laboratory documents such as Manufacturing Batch Records and Standard Operating Procedures and departmental forms
Develops the Item Master Data (Bill of Materials, Bill of Operations, etc.) in Great Plains for new assays
Follows all appropriate safety procedures, policies and precautions

Upstream Process Development Scientist Resume Examples & Samples

Support shake flask and small scale cell culture process development and characterization
Assist in preparing media, setting up, sterilization, sampling and cleaning of small scale bioreactors
Troubleshoot equipment and perform minor repairs
Experience with CHO cell culture
Bachelor's degree in in Chemical Engineering, Biomedical Engineering, or Biological Sciences
At least 1 year of related experience

Process Development Scientist, Sequencing Resume Examples & Samples

Purification of DNA polymerases and membrane proteins using FPLC
Characterizing polymerases and membrane proteins, including running SDS PAGE, HPLC chromatography, characterizing aggregation by dynamic light scatter, circular dichroism and other physical chemical methods
Reagent production, characterization and tracking QC results
Documenting and writing up production protocols, batch

Process Development Scientist Resume Examples & Samples

You will support the Manufacturing team to make sure projects run according to schedule and will be delivered with excellent quality
Your technical background and knowledge on qualification and validation will be put to use in a variety of projects and in the lab. You will be part of several core teams and take responsibility from the manufacturing side for projects related to the implementation, verification and validation of
1) Electronic Batch Records
2) Equipment
3) Manufacturing Process
4) QC methods
For this you will aid in defining the strategy, you will write protocols, reports, technical reviews and SOPs autonomously
You will assist in design transfer to Operations in a standardized fashion
You will aid in the development, qualification and validation of QC release methods for new developed IVD products
You will Collaborate, support, and communicate efficiently with relevant team members, such as Product Development, QA and Operations to align on strategy and approach
A degree in Engineering or Sciences with preferably 3 years’ experience in chemistry, biochemistry or molecular biology in a medical, pharmaceutical or diagnostic industrial environment
Experience with qualification and validation activities in a GMP environment is a strong asset
Experience in IVD process development is an added value
Experience in technical transfer of biotechnology processes is a strong added value
Technical leader who can function independently
Knowledge of one or more of the following fields: PCR methods, mutation and SNP detection (sequencing), SNP genotyping and massively parallel sequencing methods
Excellent technical writing skills (protocols, reports, standard operating procedures, test methods) and good documentation practices
Ability to interpret statistical data
Strong attention to detail and quality driven
Ability to execute effective decision-making, both as an individual and as part of a team
Strong teamplayer with a personal drive
Stress-resistant
Well-developed interpersonal skills
Hands on and pragmatic approach
Flexible
Advanced knowledge in oral and written English

Process Development Scientist Resume Examples & Samples

Collaborate with other scientists in the group to improve the yield of recombinant antibody expression in both transient and stable expression systems
Scale recombinant antibody production to an industrial level
Analyze results of data and prepare recommendations for improvement or troubleshooting
MS or PhD in Biochemistry, Molecular Biology, Bioengineering, or a related Biological Science area
5 years of industry experience, focusing on transient and/or cell line development for recombinant antibody expression and production
Extensive experience with recombinant antibody engineering and development and with media optimization and scaling-up of bioreactor processes
Proficiency with stable cell line development for recombinant antibody production
Knowledgeable of Microsoft Word, Excel, and PowerPoint, and FileMaker database
Expertise working with mammalian expression systems, in particular CHO and NS0 for recombinant antibody expression
Familiarity with ISO 9001/ ISO13485, GLP or GMP compliance

Process Development Scientist Downstream Resume Examples & Samples

Lead downstream pilot scale project to manufacture protein for pre-clinical study. Support to prepare IND-filling document
Develop expertise on downstream process development, operation of large scale bioprocess equipment and CFDA regulations
Conduct purification process development project for customer and deliver study reports to customer. Support customer to accelerate their new drug development progress from lab scale process to large scale production
Adapting training courses prepared by worldwide Fast Trak organization to the Chinese market needs. Coordinating training courses with the sales department; planning and implementing training events. Deliver lectures and lab hands-on work
Understand marketing trends to support sales department and customers with expert advice. Work closely with field application specialists and support customers by offering trouble-shootings, bioprocess development services and consulting. Offer on-site support to customers for approximately up to 20% of the working time
Support GE downstream product in maintaining scientific leadership by designing and delivering creative solutions to customer’s manufacturing challenges. Add value to GE’s customers by identifying continuous improvement opportunities in their bio-manufacturing processes
Master or PhD of chemical-engineer or biochemist or drug science related with >3 years or bachelor with >5 years of industrial experience in process development or production of biopharmaceuticals
Industrial experience and theoretical knowledge of the basic techniques used for downstream purification of biopharmaceuticals (filtration, chromatography, centrifugation, etc.) at pilot or commercial production scale. Good understanding of the basics of process economy
Good project management experience and work with global team
Accomplished presenter to critical audiences or teacher
Good people skills. Proven ability to work in team environment and able to develop working relationship with customer
Excellent written and spoken skills in English and Chinese
Fast learning
Socially competent to handle sensitive customer relationships, demonstrated problem-solving skills
5+ years industrial experience in GMP biopharmaceutical manufacturing
QbD and DoE knowledge and application experience
Experience on preparing IND and NDA documents
Demonstrated ability to deliver results while working on multiple project simultaneously, in a cross-functional team and in an international environment
Positive, optimistic, self-motivated achiever
Intelligent, in-depth technical approach
Reliable and thorough person who always delivers on promises and always promises realistically

Process Development Scientist Resume Examples & Samples

Support senior technical leads on active projects and technology initiatives
Build relationships and work closely with business partners on specific projects, as directed
Provide support in the development and transfer of product formulations to internal and external production facilities
Perform document & data collection and review; effectively communicate observations and findings to supervisor
Draft protocols, reports, and other technical documents (i.e. specifications) as needed
Execute and manage developmental stability programs to assess viability of new formulations
Assist in design and actively participate in consumer study research
Assures awareness and performs job responsibilities in compliance with current and developing regulations, regulatory agencies, and with corporate policies
Completes current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and/or safety trainings, as applicable to job requirements
BS degree with 1-3 years of related experience in a physical science capacity
Possesses proven written and oral communication skills and necessary organizational skills