Scientist, Process Development Resume Sample
Matilde Heller
47455 Desiree Parkway,
San Francisco,
CA
+1 (555) 595 2599
Work Experience
Senior Scientist, Process Development
06/2016
-
PRESENT
Phoenix, AZ
- Maintains full working knowledge of principles and theories, applying such knowledge to the direction that supports Company interests
- Develop, optimize, and scale-up bacterial and mammalian cell and virus/viral vector-based processes, including cell banking, adherent and suspension cell cultures in batch, fed-batch, and perfusion modes
- Plan, generate and execute protocols for DOE studies that include appropriate statistical analysis and generate and present reports
- Plan and perform metabolite/spent medium analyses, medium development and cell line development studies
- Assemble, operate, and troubleshoot single-use stirred tank bioreactors from bench scale to 200L working volume scale
- Plan and execute various centrifuge and cell/virus culture harvest protocols
- Support GMP manufacturing through tech transfer, training, and master batch record generation and review
- Generate scientific reports, including process development reports, manufacturing summary reports, and supportive reports for IND CMC sections
- Cross-train in Downstream PD, Virology and Analytical Development groups to gain knowledge and functional capability in these areas
Scientist, Process Development
12/2011
-
01/2016
Phoenix, AZ
- Plan, perform and evaluate relevant in-process assays and report results
- Generate and present oral presentations for peers and senior management, as required
- Ensure maintenance and monitoring of process development equipment
- Manage direct reports to be engaged and productive, and address work productivity issues as they arise
- Work effectively in a matrix management environment
- Experience in upstream process development of mammalian, viral and bacterial cultures and upstream purification of biological products. Experience monitoring the performance of laboratory processes and equipment
- Strong working knowledge of cGMP (current Good Manufacturing Practices)
- Provide observations within a developing process
- Strong computer skills (Microsoft Office products including Excel, Word, Outlook and PowerPoint)
Scientist, Bioprocess R&d-process Development
03/2005
-
11/2011
Chicago, IL
- Experience prolonged standing, along with some bending, stooping, and stretching
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment
- Attendance is mandatory
- Occasionally travel to other sites, vendor locations, and/or conferences
- Write and maintain accurate, complete, and timely data in laboratory notebooks and quality records
- To support and participate in daily laboratory operations and maintenance
- Participate in new development programme technology transfer to advance the VBU portfolio pipeline
- Knowledge of modern cell culture, chromatography, process techniques and equipment as related to biopharmaceutical process development, such as methods producing and purifying biological molecules, at medium to large scale, are essential
- Experience/knowledge of cGMP practices as applicable to upstream/downstream virus manufacturing processes, process development and/or technology transfer is desirable
Education
The Ohio State University
2000 - 2004
Engineer's Degree in Related Field With
Professional Skills
- Excellent knowledge of chemical engineering principles including: reaction kinetics, reactor design, chemical thermodynamics, heat and mass transport, engineering statistics, modeling and simulation
- Strong organizational skills, interpersonal, written, and verbal communication skills
- Excellent verbal and written communication skills; and a demonstrated ability to work as part of a project team
- Good interpersonal and communication skills and good writing skill are also required
- Computer skills (Excel, statistical analysis, databases, planning, etc.)
- Experience with using and applying computational modeling in an pharmaceutical setting
- Experience in performing analytical methods supporting process development and/or GMP manufacturing
How to write Scientist, Process Development Resume
Scientist, Process Development role is responsible for technology, modeling, manufacturing, engineering, technical, documentation, travel, training, purchasing, compensation.
To write great resume for scientist, process development job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Scientist, Process Development Resume
The section contact information is important in your scientist, process development 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 Scientist, Process Development Resume
The section work experience is an essential part of your scientist, process development 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 scientist, process development responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular scientist, process development position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Scientist, Process Development resume experience can include:
- Excellent oral communication skills as well as sound technical writing and documentation competencies
- Strong written and oral communication skills and the ability to contribute in a multi-disciplinary environment are essential
- Communicate effectively within a multi-functional team and build strong partnerships both internally and externally
- Reproducing and/or optimizing upstream processes at bench scale and effectively designing and executing scale up engineering or toxicology runs
- Extensive experience with protein and carbohydrate chemistry in general and bioconjugation chemistry specifically is strongly desired
- Experience with multi-well cell culture screening system and microbioreactors, and metabolic analyses using HPLC/UPLC systems
Education on a Scientist, Process Development Resume
Make sure to make education a priority on your scientist, process development resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your scientist, process development 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 Scientist, Process Development Resume
When listing skills on your scientist, process development 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 scientist, process development skills:
- Demonstrated strong leadership, communication and interpersonal skills to work in a collaborative team environment
- Strong leadership skills and ability to influence without direct authority in multi-disciplinary teams
- Reproducing and/or optimizing downstream processes at bench scale and effectively designing and executing scale up engineering or toxicology runs
- MS in Chemical Engineering with 2-7 years of experience or PhD in Chemical Engineering with 0-4 years of relevant experience
- Good understanding of cGMP and manufacturing, and regulatory requirements for filing and registration of vaccine and/or biologics
- Experience in automating laboratory and/or manufacturing processes
List of Typical Experience For a Scientist, Process Development Resume
1
Experience For Scientist, Upstream Process Development Resume
- Interpersonal Skills- Focuses on solving conflict, not blaming; Maintains confidentiality; Remains open to others' ideas and tries new things
- Become a role model for other process development and manufacturing employees through superb work habits and excellent occupational behavior
- A proven track record in primary packaging compatibility or particle characterization and identification techniques for biopharmaceutics
- Strong background in protein analytical methods
- Working knowledge of Python programming
2
Experience For Senior Scientist, Process Development Resume
- Participating in cross-functional collaborations to meet project timelines and material supply requirements
- Providing supervision and guidance to junior scientists or associates
- Understanding of cGMP, process safety requirements, and OSHA chemical hygiene plans
- Working Knowledge of analytical techniques such as HPLC, GC, NMR, and microscopy
- Working knowledge of Quality by Design (QbD) and Design of Experiments (DoE) and statistical software such as Design Expert or JMP would be an advantage
- Working knowledge and application of MatLab
- Tasks include daily cell culture operations, medium and buffer preparation, bioreactor operation and troubleshooting
- Maintain electronic laboratory notebooks and records in accord with scientific protocol and applicable Standard Operating Procedures
3
Experience For Senior Scientist Process Development Resume
- Maintain a high level of productivity in the lab, pilot and manufacturing plant
- Solve technical issues and support GMP manufacturing
- Plan and implement innovative chemical and analytical solutions appropriate for the commercial manufacture of APIs
- Achieve positive laboratory results through a combination of personal hands-on lab experience and overseeing the efforts of Associate and Assistant Scientists through a matrix relationship within the MilliporeSigma organization
- Execute Kilo Lab and Pilot Plant manufacture of APIs and intermediates if called upon to do so
- Handle 1-2 chemistry-based projects at various states of maturity
- Work in accordance with FDA, OSHA, EPA, DNR, DOT and other regulatory agency guidelines
- Adhere to MilliporeSigma’s ethical and behavioral standards as outlined in the employee handbook
4
Experience For Scientist, Bioprocess R&d-process Development Resume
- Education: Ph.D. or equivalent in Organic Chemistry
- Additional responsibilities comprise performance of primary recovery cell separation operations
- Developing processes and completing external (to and from client) and internal (to cGMP manufacturing department) technical transfers of upstream unit operations
- Using sound scientific and engineering principles to design robust and scalable upstream processes, in consideration of various bioreactor configurations and process formats
- Leading tech transfer to CMOs for process scale-up and GMP manufacturing including risk assessment and mitigation strategy development. Perform PIP for production support and troubleshooting
- Understanding the IP landscape around subject technologies, and developing IP strategies to ensure FTO and to create and strengthen the patent estate in the field
5
Experience For Scientist Upstream Process Development Resume
- Strong technical expertise in pharmaceutical development (formulation, freeze drying, pharmaceutical processes incl. transfers) of biologicals
- Publishing or presenting scientific findings in peer-reviewed journals or conferences, and contributing to industrial collaborations
- Writing technical summary and development reports for efficient knowledge management and regulatory filing support
- Manage specialists, technicians and operators and coordinate their activities; carry out management roles such as people management (hiring and developing)
- Ensure know-how transfer to Engineering and Production and support start-up of new or modified production processes world wide
- Excellent organizational skills, ability to respond to changing priorities and short lead teams for multiple tasks and ability to identify problems and work towards solutions
- Coordinate with mAb PTL’s, early research scientists, clinical, DSP, analytical, and formulation scientists to maintain and publish a schedule of upcoming preparations
- Technical and scientific responsibility for development and implementation of new processes as well as process optimization
6
Experience For Senior Scientist, RD&Q Process Development Resume
- Establish all necessary scale-up data via development work on lab and piloting scale, recommend technical process/plant set-up and document results in internal reports
- The position works in partnership with colleagues in Zoetis Global Therapeutic Research and Global Biological Research to develop new biopharmaceutical and biological candidates
- Partnership with colleagues in Pilot operations and manufacturing to ensure efficient technical transfer of new candidates into GMP manufacturing operations
- Knowledge in the coordination of activities at third party manufacturer and vendors
- Hands-on experience with different analytical test procedures like functional testing and also with automated and semi-automatic aseptic filling processes and equipment
- Work independently, respond to changing priorities and short lead times for multiple tasks and to identify problems and work toward solutions as well as to influence without direct authority in multi-disciplinary teams
- Participate to recurrent team meeting and update on progresses
- Contribute to support immediate resolution of process development issues and learning implementation for the area of responsibility
7
Experience For Scientist Process & Transfer Development Resume
- Plan and coordinate manufacturing trials in locations all over the region and conduct root cause analysis
- Offer Technical support to factories and assist them in problem solving in products and processes
- Responsible for cell culture process development and manufacturing support for late-stage clinical and commercial biologics
- Trains and mentors employees on areas of technical expertise and compliance issues relevant to the lab setting
- Collaborates and leads interactions with clients, vendors and external partners
- Experience in upstream bioprocess unit operations such as aseptic processing techniques, culture of adherent and/or anchorage dependent cells, molecular assays, and 3D bioreactors are required
8
Experience For Scientist, Downstream Process Development Resume
- Experience in downstream bioprocess unit operations such as centrifugation, cell washing techniques, filtration systems, tangential flow filtration and chromatography is required
- Perform complex mathematic and statistical analysis and to work with Excel /JMP/Minitab and other data analysis tools to collect and analyze data
- Authors study design, technical reports, SOPs and experimental designs
- Lead several small to medium size projects within cross-functional team
- Conduct research work, lab & pilot plant experiments
9
Experience For Scientist Process Development Gum & Candy Resume
- Counsel others in the use of R&D systems and how to plan their own trials or projects
- Interface with other functional groups to facilitate efficient technology transfer/scale-up of production processes
- Conceive and execute continuous process improvement activities to improve process efficiency, robustness and product quality
- Supports the successful process development and technology transfer of Cell and Gene Therapy products. Areas of focus include culture of adherent and suspension primary cells, cell strains, and immortalized cell lines, production of viral vectors and downstream processing of cell products and viral vectors
- Independently performs activities required for successful operation of assigned project area including
- Designs experiments and writes detailed experimental protocols, reviews and reports data appropriately
- Contributes to coordination of activities in the laboratory, maintains laboratories and equipment, reviews and signs logbooks
10
Experience For Principal Scientist Downstream Process Development Resume
- Bring prior knowledge of the concepts of API continuous development and manufacturing to provide chemical engineering expertise for the development of continuous API platforms, workflows and processes
- Partner with chemists, analysts, mechanical engineers and chemical engineers from across Pfizer R&D and manufacturing organizations to assess existing continuous API platforms and design novel continuous API platforms for selected unit operations
- Prototype continuous API platforms in the laboratory and Kilo Laboratory in Groton and enable for Pilot Plant and commercial manufacturing through the development of modular and industry standardized units
- Apply chemical engineering principles (reaction kinetics, thermodynamics, heat and mass transfer, and mixing effects) to evaluate and develop scalable and robust processes for the manufacture of API using continuous technologies
- Develop and apply new and existing continuous process technologies to enable development and transfer of safe and scalable processes to API manufacturing facilities
- An strong background in organic chemistry and/or biochemistry is required
- Experience with ISO-13485 and other regulatory standards
- Experience with Process Analytical Technology
- Leverages engineering modeling to efficiently probe the design space in the laboratory and rapidly develop optimal manufacturing processes
List of Typical Skills For a Scientist, Process Development Resume
1
Skills For Scientist, Upstream Process Development Resume
- Demonstrated problem-solving skills and capability to overcome complexed issues
- Project management skills including the ability to manage multiple projects and evaluate project resource requirements
- Work effectively in a highly collaborative and dynamic environment
- Effectively communicates with clients, vendors, and cross functions teams
- Experience performing Phase 1 clinical manufacturing
- A demonstrated foundational understanding of organic chemistry
- A strong grounding in the fundamentals of the biology and a knowledge of metabolic pathways is desired
2
Skills For Senior Scientist, Process Development Resume
- Demonstrated knowledge of Downstream processing
- Experience maintaining written records of work in the form of laboratory notebooks (paper or electronic) is required
- Experience in primary packaging design and development, either in pharmaceutical, medical device or biotech industry is required
- Design and execute experiments in support of process development, validation, trouble-shooting and continuous process improvement
- Responsible for participating in new product technology transfer, and process qualification and validation activities
3
Skills For Senior Scientist Process Development Resume
- Support new product technology transfer, and process qualification and validation activities
- B.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, Biology or related programs with 5+ years of relevant experience [OR]
- M.Sc. in Chemical Engineering, Biochemical Engineering, Biotechnology, Biology or related programs and 2+ years of relevant experience
- Relevant (process development, process engineering) work experience, preferably at a multinational packaged-food company
- Relevant experience in areas of cell culture process development, scale-up and/or manufacturing support
4
Skills For Scientist, Bioprocess R&d-process Development Resume
- Strong sense of urgency, engagement and self-motivated desire to achieve
- Relevant work experience in Biologics downstream development and manufacturing
- Experience with bioreactor operation (fed-batch and perfusion processes). Understanding of process scale-up and mass transfer
- Experience with high throughput automation systems, including liquid handlers and general lab automation
- Upstream process development experience in large scale bioreactors, preferably Single Use Bioreactors
- Knowledge of method qualification and validation (ICH guidelines)
- Demonstrated passion for the consumer. Ability to find the insights through consumer interaction
5
Skills For Scientist Upstream Process Development Resume
- Excellent organization to multi-task and manage multiple projects
- Author technical reports, validation documents and relevant sections of annual product quality reports as required
- GMP manufacturing experience/exposure
- Offer insights based on experience to group members to help solve existing problems
- Plan and prioritize cell culture related activities
- Operating, maintaining, and troubleshooting large scale bioreactors in an industrial setting
- Working knowledge of reaction modeling, property prediction, and simulation computational tools including: DynoChem, Visimix, Aspen, Fluent, and Cosmotherm
- Working knowledge of application of in-situ analysis tools to process understanding including: FTIR, FBRM, UV/Vis
- Capturing, analyzing and interpreting high volumes of data
6
Skills For Senior Scientist, RD&Q Process Development Resume
- Transferring processes to cGMP manufacturing, manufacturing support
- Evaluating and developing new upstream production technologies, particularly to support conversion of unit operations to single-use disposable systems
- Supporting the FTBM Business and marketing teams
- Documenting results in electronic laboratory notebooks and reviewing the notebooks of peers
- Working knowledge of UPLC, MS, and NMR
- Working knowledge of Cell Clarification/Harvest and Downstream purification
- Developing scalable and robust purification processes for multiple biologics programs
- Authoring technical reports and regulatory documents
7
Skills For Scientist Process & Transfer Development Resume
- Collaborating with upstream and downstream scientists to ensure project deliverables are timely met
- Providing technical/scientific leadership on development activities in cross-functional teams and professional affiliations
- Working with large scale production systems (examples: Cell culture stacks, Hyperstacks, >50L Bioreactors, AKTA Pilot/Ready)
- Designing and execution of feed and media studies
- Designing and execution of harvest / clarification studies
- Developing highly productive upstream processes in a timely manner for novel protein therapeutics such as bispecific antibodies
- Supporting the BMS Business team
- Provide on-floor technical support for cell culture manufacturing including routine process monitoring/trending, and troubleshooting of any process issues
8
Skills For Scientist, Downstream Process Development Resume
- Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds
- Process development - planning, conducting and reporting experiments
- Develop new processes or improve existing processes / methods by leveraging from journal articles and/or from knowledge of other scientists
- Proficiency with personal computers including word processing, spreadsheets, PowerPoint and relevant scientific software is desirable
- Plan and execute experiments and analyze resulting data using appropriate software
9
Skills For Scientist Process Development Gum & Candy Resume
- Knowledge in aseptic manufacturing, filling and GMP is beneficial
- The position also interacts with external parties including vendors, contractors, research collaborators, and contract manufacturers working in the DSP field
- Leads, executes and documents experimental studies, authors local Standard Operating Procedures (SOPs) and purchasing plans
- Mentor and develop others according to the AbbVie culture including post-docs
- Author, utilize, and train employees on a wide variety of written procedures, including batch records and operating procedures
- Some knowledge of powder flows; fundamental engineering/physical concepts such as mass, momentum, and energy transport phenomenon; and a mathematical ability to solve linear, non-linear, and differential equations
10
Skills For Principal Scientist Downstream Process Development Resume
- Experience with discrete element modeling (DEM) method – commercial or open-source software
- Design, manage and execute studies pertaining to Vaccine Process Development
- Conduct experiments to establish, optimize and qualify manufacturing methods for the production of live attenuated and purified inactivated viral vaccines
- Analyze data from studies, method development, or tech transfer activities, and author reports for submission to multiple parties, including regulatory agencies such as the FDA and EMA
- Assist in establishing Drug Product process development infrastructure and services for parenteral drug products for clinical and commercial use (20%)
- Microbial Physiology, Biochemistry, or Biochemical Engineering
- Hands-on and in-depth understanding of mammalian cell culture and cellular metabolism
- Hands-on expertise in bioreactor system operation including AMBR, and wave and stirred tank bioreactors is essential
List of Typical Responsibilities For a Scientist, Process Development Resume
1
Responsibilities For Scientist, Upstream Process Development Resume
- Partner with experts in process analytical technology, automation and control to enable the delivery of integrated continuous unit operations for API development and manufacture
- Working in a modern automated laboratory, performs laboratory experiments to develop process understanding using a One Factor at a Time (OFAT) and/or a Design of Experiments (DoE) methodology as appropriate. Performs experiments to understand reaction mechanisms and kinetics, stability, solvent exchange, etc
- MS in Chemical Engineering with 2-5 years of experience or PhD in Chemical Engineering with 0-4 years of relevant experience required
- Build a strong understanding of granular flows and pharmaceutical unit operations, and apply knowledge to support advancement of predictive sciences at Pfizer
- An ability to safely perform laboratory tasks (chemical reactions, weighing of solids, solution preparation, reagent addition) is required
- Developing high throughput scale down models for purification processes
- To support modeling efforts, plan and execute experimental studies in collaboration with experimental experts
- Support Pfizer’s key technology platforms: Portable, Continuous, Minature and Modular (PCMM) tablet manufacturing and Multiparticulates
2
Responsibilities For Senior Scientist, Process Development Resume
- Design of experiments and analysis of experiemental results using Excel spreadsheets and/or statistical analysis software
- Guide and train technicians/scientists on process development/troubleshooting efforts
- Facilitate BacVac collaborations with contract research organizations (CROs) for outsourcing of USP experiments
- Execute experiments to optimize and enhance protein production using mammalian expression platforms
- Keep abreast of scientific/ technological development by participating in scientific meetings/ seminars and through regular scientific review
- Satisfactorily complete all GLP and safety training in compliance with departmental requirements and follow appropriate safety practices in the workplace
- Make concise scientific presentations and publications within and outside AbbVie including conferences
- Drive development of business practices and continuous improvement thereof, including feedback from relevant stakeholders on international level
- Contributes to the transfer, evaluation and optimization of analytical assays used for in-process testing and characterization
3
Responsibilities For Senior Scientist Process Development Resume
- Bioreactor operation and troubleshooting
- Possesses thorough knowledge of the science of cell culture, including growth and characterization of primary cells, cell strains, and immortalized cell lines
- Contributes to the preparation of the CMC section of the NDA. Participates in data verification, PAI preparedness, and post submission query response,
- Champions the development of novel laboratory development instrumentation and software modeling tools to improve process understanding. Leads the development and implementation of new and existing workflows and methodologies
- BS/MS Chemical Engineering with 5-8 years of relevant chemical or pharmaceutical continuous platform and process development experience or PhD in Chemical Engineering with 0-3 years of experience
- Understanding of organic chemistry and chemical engineering principles and fundamental principles of continuous processing from a laboratory and manufacturing perspective
- Apply chemical engineering principles, modeling tools, and experimental skills using data-rich laboratory instrumentation to improve process understanding and assess proposed process modifications
- Apply an understanding of plant equipment capabilities and operations to assess scalability and robustness for API processes
4
Responsibilities For Scientist, Bioprocess R&d-process Development Resume
- Select, develop, and apply new and existing process technologies to facilitate process design to achieve project goals
- Contributes to the preparation of the Chemistry and Manufacturing Controls (CMC) section of the New Drug Application (NDA). Participates in data verification, PAI preparedness, and post submission query response. Collaborate and prepare internal research reports and technical presentation
- Champion the development of novel laboratory instrumentation and software modeling tools to improve process understanding. Leads the development and implementation of new and existing workflows and methodologies
- Apply computational models and tools to generate results needed to support Pfizer portfolio projects and technologies
- Deploy and use a variety of computational tools – especially DEM to model powder flows in pharmaceutical unit operations
- Use and apply other computational tools – process models, statistical models, data analysis and visualization, programming support and automation – to accelerate the drug development process
5
Responsibilities For Scientist Upstream Process Development Resume
- Work closely with project scientists, which entails regularly attending project meetings and individual meetings to inform self and others, in order to tailor modeling activities to project needs
- Communicate and present results internally at meetings and, on occasion, at external forums
- Serves as a technical lead for process development projects, responsible for experimental design of process development studies, applying Quality by Design principles and Design of Experiment methodologies where appropriate
- Interacts internally with Manufacturing, Engineering, Facilities, Validation, Quality Assurance, Quality Control, Project Management, and Materials Management groups. Interacts externally with clients,material/equipment vendors and commercial partners
- Reviews laboratory notebooks and logbooks
- Development of laboratory- and pilot-scale process chemistry models
- Execution of process characterization and feasibility experiments
6
Responsibilities For Senior Scientist, RD&Q Process Development Resume
- Operation of laboratory equipment and instruments
- Subject Matter Expert in process technology, preferably within biotechnology/pharmaceutical industry
- Plan, execute/supervise, and evaluate bacterial fermentation experiments independently and systematically, for developing/improving, bacterial fermentation processes and primary recovery, as basis of vaccine upstream processing (USP)
- Develop strategies for scale-up/down and process control
- Support technology transfer of USP processes from BacVac to large-scale development, either at Janssen large-scale facilities, or with help of contract manufacturing organizations (CMOs) under BacVac’s supervision
- Help organize scientific and technical documentation supporting development activities, in coordination with Janssen support departments and governance bodies
- BS, MS in Chemical Engineering with 7+ (BS), 5+ (MS)
- Execute experiments to optimize and enhance antigen expression in microbial systems
- Evaluate and incorporate media and feeds to improve cell culture/fermentation processes for improved product yield and quality
7
Responsibilities For Scientist Process & Transfer Development Resume
- Initiate experiments which focus on characterization, scale-up, and demonstration of process robustness
- Perform Design of Experiment (DOE) studies to fully characterize processes
- Collaborate with colleagues within Vaccine Research and Development organization including Bioprocess Purification, Analytical, and Formulation Development groups
- Present problems and propose solutions in discussions with group members
- Independently analyze experimental data
- Author and review cell culture procedures and reports
- Utilize new technologies and establish those technologies to improve cell culture capabilities of process development group
- Where applicable, perform job responsibilities in compliance with GLP and all other regulatory agency requirements
- Make timely notebook entries and review for completed experiments
8
Responsibilities For Scientist, Downstream Process Development Resume
- Proactively drive the process development of parenteral formulations with a focus on antibody drug conjugates
- Independently develop scale-up and scale-down strategies and models for parenteral manufacturing processes e.g. from bench to pilot-plant scale or to external partners
- Being the project lead process developer within a joined CMC team, including responsibility for process design and authoring of scientific as well as regulatory documents and patents
- Builds strong relationships to other functional units and drives activities in collaboration with partners like TPMs
- Independently plan, perform and document scientific experiments and extract as well as communicate relevant findings in reports and presentations
- Performs upstream activities in support of viral vaccine development programs
9
Responsibilities For Scientist Process Development Gum & Candy Resume
- Contributes to regulatory filings and interactions with health authorities to ensure successful registration vaccine candidates
- Summarizes results in written reports and oral presentations
- Utilize deep technical skills and creative problem solving skills to successfully scale lab made prototypes to full-scale production processes, utilizing technology from internal & external sources to deliver superior products with excellence and speed; beginning as early as conception and running through development
- Support creation of broad exclusionary strategy (IP) where and when applicable
- Utilize technical skills and creative problem solving skills to successfully scale lab made prototypes to full-scale production processes, utilizing technology from internal & external sources to deliver superior products with excellence and speed; beginning as early as conception and running through development
- Identify, champion and adapt new technologies, tools and processes; and help develop best practices in innovation and technology throughout Research and Development
- Champion quality to ensure products consistently deliver superior quality for the consumer
- Implement process controls and devise test methods to ensure product quality is in compliance with finished product specifications
10
Responsibilities For Principal Scientist Downstream Process Development Resume
- Knowledge of chemical engineering principles including: reaction kinetics, reactor design, chemical thermodynamics, heat and mass transport, engineering statistics, modeling and simulation
- Responsible for successful process development and technology transfer of Cell and Gene Therapy products, with a focus on gene therapy products and associated vector production
- Experience with BS/MS or PhD in biology, biochemistry, immunology, bioengineering, or related field
- Experience with authoring technical transfer protocols for cell banking and cell/gene therapy products. -
- Responsible for process development timelines for client products
- Daily cell culture operations
- Medium and buffer preparation
- Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation
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