Process Development Scientist Resume Sample
Ethelyn Goldner
349 Daija Court,
Boston,
MA
+1 (555) 439 2972
Work Experience
Senior Process Development Scientist
02/2016
-
PRESENT
Phoenix, AZ
- Familiarity with ISO 9001/ ISO13485, QSR’s or GMP compliance requirements
- Leads departmental or functional group activities related to a development project
- Effectively leads or participates on drug substance development teams as a team leader, team member, or primary department representative
- Identifies resources and develops timelines for project activities
- Collaborates with scientists outside the department
- Knowledge of cGMP requirements and facilities
- Hands-on experience with scalable bio-production with direct experience downstream technologies (chromatography skids, HPLC, column packing, membrane chromatography, ultrafiltration/diafiltration) and analytical methods
- Excellent written and oral communication skills including experience with technical writing are mandatory for this client-facing role
- Proactively lead projects to develop economical and environmentally sound manufacturing processes for new and existing silicone and emulsion-based products, from laboratory to manufacturing scale. This includes but is not limited to laboratory development, pilot-scale testing, evaluation of equipment options and production trials, as well as testing and validation of new raw material candidates
Process Development Scientist
10/2012
-
10/2015
New York, NY
- Hands-on laboratory, pilot plant, and manufacturing scale-up work in support of projects. Maintain safe operations with excellent housekeeping practices
- Supervision of laboratory technicians where applicable
- Build strong relationships and create an interface among Global Technology, Process Technology, Continuous Improvement, Procurement and Operations teams to maximize efficient execution of projects
- Support of manufacturing through key troubleshooting investigations, optimizations and new process implementation. Identify opportunities for productivity and quality improvements
- Deliver cost analyses to support new product and business decisions. Provide SAP material master and workflow support
- Lead projects in Safety and ISO for the Process Technology organization
- Prepare reports documenting work, operating procedures, patent disclosures for inventions, and business presentations
- Use of modeling and statistical-based tools to establish product and process capability where applicable
- Leads design of experimental plans based on the defined deliverables
Process Development Scientist / Engineer
06/2010
-
06/2012
Houston, TX
- Conducts complex analyses to support process development. Works with Process Development and Manufacture groups to trouble-shoot process challenges
- Records results in notebook accurately, clearly, and regularly, and reviews documentation by others
- Prepares protocols, reports, and test methods and writes SOPs
- Maintains and ensures safe laboratory environment and work practices
- Executes appropriately record and evaluate experimental data, including the writing and revising of process development reports and technology transfer protocols as needed
- Remains current in the field by review of relevant scientific literature and attendance at appropriate scientific seminars and conferences
- Identify and develop new process or product opportunities that create distinct value and enable business growth
- Participate in intellectual property development and regulatory activities to support project and product line objectives
Education
Grand View University
2005 - 2009
Engineer's Degree in Life Sciences
Professional Skills
- Experience with the development of bioreactor protocols, establishing cell culture system, and / or successful development and transfer of processes to cGMP manufacturing
- Experience or knowledge of analytical methods and in process controls commonly used in manufacturing processes such as cell count viability, flow cytometry, and molecular biology techniques
- Aseptic drug product validation experience such as; media fill, sterilisation validation, equipment qualification, process validation
- Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects
- Strong understanding and hands-on experience of biochemistry and protein sample handling. Direct experience from a Pharmaceutical or Biotechnology Company
- Strong problem solving and effective cross-functional communication skills
- Excellent record keeping and communication skills
How to write Process Development Scientist Resume
Process Development Scientist role is responsible for scientific, advanced, interpersonal, software, microsoft, organization, analysis, leadership, laboratory, design.
To write great resume for process development scientist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Process Development Scientist Resume
The section contact information is important in your process development scientist resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Process Development Scientist Resume
The section work experience is an essential part of your process development scientist resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous process development scientist responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular process development scientist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Process Development Scientist resume experience can include:
- Validation: Write protocols and direct the execution of process and cleaning validation to provide documented evidence of performance
- Strong scientific, computer, organizational, and documentation skills
- Excellent interpersonal, communication (oral and written), and collaboration skills and attention to detail
- Strong communication and interpersonal skills, and the ability to work flexibly in a cross-functional team environment
- Strong independent problem solving, communication and quanitative skills
- Motivated self-starter with excellent interpersonal and organizational skills
Education on a Process Development Scientist Resume
Make sure to make education a priority on your process development scientist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your process development scientist experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Process Development Scientist Resume
When listing skills on your process development scientist resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical process development scientist skills:
- Good problem solving skills requiring the application of scientific theory
- Strong understanding and hands-on experience of biochemistry and protein sample handling. Direct experience from Pharmaceutical or Biotechnology environments
- Excellent verbal communication and scientific writing skills
- Consistently demonstrates facilitation and listening skills
- Motivated collaborator with strong technical expertise and interpersonal communication skills
- Demonstrated written, presentation, and interpersonal communication skills across a divergent audience
List of Typical Experience For a Process Development Scientist Resume
1
Experience For Process Development Scientist Downstream Resume
- Develop validation protocols; conduct validation and issue validation reports
- An excellent understanding of the unit operations associated with the manufacturing of solid and liquid pharmaceutical dosage forms
- Write protocols and direct the execution of process and cleaning validation to provide documented evidence of performance
- At least two years related laboratory experience including aseptic and cell culture techniques either in a lab scale or pilot scale setting
- Use cell science knowledge, theoretical understanding, and experience in the development, transfer and implementation of manufacturing processes
- Designs, monitors, or conducts strategies or projects which significantly contribute to attaining high priority goals
2
Experience For Process Development Scientist / Engineer Resume
- Demonstrated ability to write comprehensive reports at the conclusion of projects for internal and customer use
- Designs, monitors or conducts experimental strategies or projects which significantly contribute to attaining high priority goals
- Organizing scientific reports, tagging documents, and uploading to data management systems
- Identify and evaluate emerging technologies to determine their applicability in gaining process efficiency and/or improving product safety and quality
- Provide troubleshooting and root cause analysis for manufacturing-related investigations
- MS or BS in Bioprocessing Science, Chemical Engineering, or closely related discipline
- Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing
3
Experience For Senior Process Development Scientist Resume
- Work closely with manufacturing and GMP operations to coordinate project related equipment and activities
- Has ability to apply scientific or engineering principles, established cGMP techniques, and company’s policies and procedures in completion of job tasks
- Contribute and support scientific or engineering expertise toward the design and development of new process ideas that support client product concepts
- Support non-standard shift operations including extended hours, as per business needs
- To support development or characterization of bulk immunostimulants or other manufacturing processes
- Perform protein purification using column chromatography techniques
- Check daily results and reviewing them with the appropriate lead to ensure data quality
- Support tech transfer of assays and methods to manufacturing
4
Experience For Recombinant Antibody Process Development Scientist Resume
- Maintain batch records and documentation according to cGLP/cGMP standards
- Problem solving abilities to recognize basic problems and suggest potential solutions
- Owns the accountability and responsibility of delivering to client needs and timeliness
- Hands-on technical oversight of small-scale manufacturing activities as well as preparation of technical reports to summarize optimization efforts
- Scales up the processes and tech transfers to cGMP clinical manufacturing
- Performs scale-down modeling, hold-time, and viral clearance studies
- Collaboration with Subject Matter Experts to ensure correct filing of documents to appropriate databases
- Formulation and filling of biologic, vaccine, and small molecule pharmaceutical products
- Apply statistical analysis in-order to solve processing issues and evaluate opportunities for process improvements
5
Experience For Senior Associate Process Development Scientist Resume
- Identifies and evaluates new test methods, related equipment and technology for assessing process and product quality characteristics
- Acts as a resource to provide technical and scientific troubleshooting support to company departments, as needed, in area(s) of expertise
- Works with department management to identify and develop objectives and timelines in support of new and ongoing development projects
- Support and comply with corporate/local safety and food safety policies and procedures
- Design and carry out multistep organic syntheses, isolation, and purification of targeted products
6
Experience For Associate Process Development Scientist Resume
- Be able to organize work time efficiently so that several operations can be carried out simultaneously
- Work closely with other chemistry and analytical laboratory staff to coordinate project activities and resource usage in a matrix organization
- Work to ensure that a spirit of teamwork and cooperation exists within the group at all times
- Maintain familiarity with the company’s chemical hygiene plan, and conduct laboratory operations in a safe manner at all times. Exhibit safety awareness and safe work practices
- Address routine administrative requirements in a timely fashion
- Maintain a clean, safe laboratory work area
- Prepare solutions and culture media and maintain multiple cell lines
- Perform hands-on development and scale-up of robust FPLC protein purification methods based on methods transferred from R & D
- Execute, 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
7
Experience For Fill Finish Process Development Scientist AS Resume
- Perform tissue culture based experiments on live vaccine products, process intermediates, and related experimental samples
- Prepare solutions and culture media
- Maintain multiple cell lines
- Strong communication skills, both written and verbal. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information, data and interpretations of experimental results and respond to questions from co-workers and groups of managers
- Proficiency with MS Word, Excel, Project, and Power Point and other related computational tools
- Strong reasoning and problem solving skills. Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret a variety of technical instructions in mathematical or diagram form and understand and manipulate abstract and concrete variables
- 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
- Provide continual development of mammalian cell product manufacturing processes (cell isolation, culture, cryopreservation, formulation and fill), including scale-up and control strategies
8
Experience For Biologics Process Development Scientist Resume
- Knowledge of the regulatory environment, particularly principles of GMP, process validation, pharmaceutical development, quality by design, and risk management
- Broad experience with cell culture and aseptic techniques
- Design, execute laboratory experiments, analyze data, and author technical reports to support process development
- Develop strategies, methods, and controls for internal material preparation and use
- Transfer robust processes to production groups
- Develop SOPs and other documents for implementation into GMP environment
- Generate high quality documentation to support regulatory filings and maintain proper documentation of all experimental procedures and results
9
Experience For Principal Process Development Scientist Resume
- Responsible for successful development and execution of state-of-the-art manufacturing processes for cGMP manufacturing within the Cell Therapy Development matrix
- Interact with new or existing Cell Therapy clients to document and transfer new processes to Lonza sites and communicate and present the work in meetings
- Design and review of cell-based assays including, but not limited to, morphological assessment, cell proliferation, functional differentiation, cytotoxicity, detection of marker expression (ICC), Flow Cytometry, qPCR and ELISAs
- Provide technical and scientific leadership to other team members. This includes providing assistance to management in the process design of new, unique or existing protocols
- Oversee the initial technical training of specific Process Development protocols to Cell Therapy Manufacturing Teams
- Establish and maintain a good working relationship within the operations department and other departments such as Research and Technology (R&T), Quality Control (QC), Quality Assurance (QA) and Project Management (PM)
- Lead, review and/or train/assist in writing and revising technical documents including laboratory SOPs, protocols, reports and batch records
10
Experience For Process Development Scientist, Sequencing Resume
- Support Research and Technology (R&T) projects by providing constructive technical feedback and improving new processes as they are being transferred into Cell Therapy Development prior to offering to clients
- 7． Able and willing to travel up to 30% of the time
- Establish leads and/or participate in technical forums for sharing of best practices and application of formulation process expertise
- Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies
- Provide technical support for the manufacturing of pharmaceutical and nutritional dosage forms
- Develop new and improved manufacturing processes for current products
- Ensures all team members comply with safety rules and regulations
- Planning and performing process development and/or tech transfer studies in PD setting as related to all downstream product purification development, including analytical HPLC and other supporting analytics as needed by vector type
- Develops and follows timelines for completing project team work
List of Typical Skills For a Process Development Scientist Resume
1
Skills For Process Development Scientist Downstream Resume
- Strong data and time organization/management skills with attention to detail and desire to achieve team and individual goals
- Good MS Excel, Visio and Word skills
- Advanced scientific writing, problem solving skills and abilities to bring in new technologies are highly desirable
- Experience writing and validating manufacturing protocols, quality control test methods and assays
- Advanced scientific writing, problem solving skills and abilities with technology commercialization
- Strong understanding and extensive hands-on experience in protein chromatography, including affinity, ion exchange, and hydrophobic interaction chromatography
- Prior experience in Microbiological Quality at both the technical and management levels providing support for microbiological methods
- Demonstrated track record of independent critical thinking and scientific achievement in research, exemplified by a strong publication and/or patent record
2
Skills For Process Development Scientist / Engineer Resume
- Superb organization and time management skills with the ability to run overlapping experiments
- Advanced skills in technical writing and presentation capabilities
- Participate in global cross-functional teams, working effectively in a highly matrixed team environment to advance programs
- Advanced laboratory work skills
- Experience in technology transfer and process validation lifecycle
- Build relationships to effectively interact in cross-functional teams of technical experts; interfacing with adjacent departments
- Strong fundamental knowledge and experience with viral vectors, preferably lentivirus or alphavirus based systems
3
Skills For Senior Process Development Scientist Resume
- Position title to be commensurate with experience and skill-set
- Effectively communicate, explain, and recommend to colleagues and management the results of designs, studies, and/or projects
- Conduct Validation and issue Validation reports
- Education Requirements and Skills Requirements
- Leading development and validation of new testing methods and processes, draft new protocols
4
Skills For Recombinant Antibody Process Development Scientist Resume
- Working towards production and project timelines to ensure deadlines are met. Strong continuous improvement mindset
- Expert understanding and experience on analytical testing and sample handling
- Experience with leading piloting teams and operating pilot facilities
- Experience in developing, leading, and participating in multidisciplinary teams
- Good understanding of process monitoring and statistical tools
- Experience implementing chemistry with contract manufacturing organizations
- Experience dealing with contract manufacturing organisations
5
Skills For Senior Associate Process Development Scientist Resume
- Experience in industrial analytical laboratories supporting method development and testing of commercial or clinical protein products
- Experience designing and running process development microbiology laboratory
- Advanced experience in working closely with scientific and manufacturing disciplines across process development, clinical, and commercial operations
- Experience with immunophenotyping using flow cytometry
- Experience in collaboration across engineering, QA/QC, operation, application, regulatory, and sales/marketing
- Proven track record problem solving and trouble-shooting protein purification processes, preferably in a process development environment
- Processes involving the handling of solids and slurries
- Experience plating into 96- and/or 384-well plates using an automated liquid dispenser is desirable
- Experience in resin synthesis and process development for resin manufacturing
6
Skills For Associate Process Development Scientist Resume
- Good understanding of procedures and concepts within product development, formulations, chemical process development, tech transfer, process safety
- Experienced in parenteral aseptic formulation/filling processes
- Experience solving issues in the development of a commercial large-scale chemistry process
- Experience with the use of analytical instruments (HPLC, NMR, IR and MS) and interpreting the scientific data based upon these techniques
- Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools
- Knowledge or direct experience with state-of-the art advanced materials, sensing, data acquisition, tools and technologies
- Demonstrated ability to critically analyze and interrogate various biophysical data sets to drive attribute understanding and new technology development
7
Skills For Fill Finish Process Development Scientist AS Resume
- Experience with the quality testing methods and interpretation of results for biological molecules
- Advanced understanding and hands-on experience in various analytical platform such as qPCR, immunoassays, gels
- Fundamental understanding and experience in mammalian protein expression and expression vector design
- Experience with automation and high throughput sample processing
- Experience in culturing PBMCs, human T cells and mammalian cell lines
- Experience with gene editing techniques such as transposons, CRISPR/Cas9, mRNA and LVV
- Experience in filtration operations, including ultrafiltration/diafiltration (UF/DF)
- Demonstrated success working with diverse team members in a dynamic, cross-functional environment
8
Skills For Biologics Process Development Scientist Resume
- Adapt to changing project priorities and timelines
- Strong knowledge of GMP/ GLP regulations in cGMP/ cGLP manufacturing environment
- Technical writing experience highly valued
- Related experience working in a cGMP biopharma/biotech environment
- Experience with development of bioreactor protocols and scale up studies for mammalian cells or stem cells is highly desirable
9
Skills For Principal Process Development Scientist Resume
- Be organized, have multi-task project experience and be able to communicate & work well with other departments
- Demonstrated ability to propose and drive new scientific initiatives
- Relevant experience in the pharmaceutical, biotech, or related industry which includes participation and contribution to scientific project teams
- Drug product process development experience in the pharmaceuticals/biotechnology industry
- Demonstrated ability to communicate technical information at appropriate levels based on audience
- Demonstrated ability to independently identify, develop and implement scientific solutions to practical problems
10
Skills For Process Development Scientist, Sequencing Resume
- Understanding of regulatory requirements for chemistry, manufacturing and controls (CMC) production including cGMP’s and ICH guidelines
- Optimizing existing processes and protocols to improve production efficiency
- Maintaining batch records and documentation according to cGLP/cGMP standards
- Culturing and expansion of clonal cell line, assay ready, and bioassay cells following detailed SOPs
- Interpreting results, independently troubleshoot and resolve production and development issues
- Performing all production processes in accordance with GMP
List of Typical Responsibilities For a Process Development Scientist Resume
1
Responsibilities For Process Development Scientist Downstream Resume
- Advanced scientific analysis and troubleshooting skills
- Communicate and work effectively in cross-functional teams, influence technical approaches and support strategy execution
- Effectively collaborate and communicate with other departments/groups
- Training and experience of operating Thermo Q-Exactive mass spectrometers and Agilent and Waters HPLCs and UHPLCs
- Working knowledge of Good Laboratory Practice
- Pharmaceutical manufacturing experience in either a drug product or drug substance manufacturing environment
- Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up
- Experience interacting with or working within a CMO
2
Responsibilities For Process Development Scientist / Engineer Resume
- Experience with advanced statistical/analytical techniques and machine learning algorithms
- Aseptic processing experience and familiarity with cGMPs
- Experience supporting Drug Substance facilities
- Experienced with data integration or data analysis tools such as Product Lifecycle Management (PLM), Dynamic Mapping Engine (DME), PI Process Book or SIMCA
- Process, product and/or data monitoring experience
- PhD in a biotechnology related field with 3+ years relevant experience (including Post Doc)
- A good track record for delivering objectives on time and within budget
3
Responsibilities For Senior Process Development Scientist Resume
- Extensive experience with recombinant antibody engineering and development
- Experience with assays and common methodologies for viral vector characterization
- Experience with shake flasks and lab-scale bioreactors
- Experience in cryopreservation of mammalian cells is preferable
- Maintains substantial knowledge of state-of-the-art principles in antibody purification, formulation and validation
- Demonstrates potential for technical proficiency, independent thought, problem-solving, and scientific creativity
- Programming using R, VBasic, C++, machine learning languages
- Analyzing analytical methods data
4
Responsibilities For Recombinant Antibody Process Development Scientist Resume
- Working closely with R&D to ensure smooth, efficient and the successful execution of product transfer to Cell Services
- Troubleshooting issues related to product and scale up performance
- Understanding of physical/chemical stability of proteins and how process related stress impacts product quality
- Understanding of data structures and the different data types
- Coordinate and support tech transfer activities by drafting protocols, reviewing data, and writing reports
- A superior understanding of process development, analytical characterization, and cGMP manufacturing is required, preferably relating to viral-based vectors
- MS or BS in Bioprocessing Science, Chemical Engineering, or similar discipline
5
Responsibilities For Senior Associate Process Development Scientist Resume
- Optimization of cell freezing process using Controlled Rate Freezer
- Knowledge of statistical processing of data, including related software like Excel, Spotfire, JMP or ArrayStudio
- Doctorate in Chemical Engineering, Biochemical Engineering, or other relevant sciences
- Hands-on laboratory work, managing projects, and coordinating development activities with other Pfizer sites/external contract research organizations
- Comfortable working in cross-functional project teams in a matrixed fast-paced clinical grade manufacturing organization
6
Responsibilities For Associate Process Development Scientist Resume
- Work cross-functionally to deliver CMC regulatory documents and supporting documentation in support of Amgen’s small molecule regulatory filings
- Provide scientific results that support the generation of publications, patents and regulatory submissions, and monitoring
- Document customer interfacing activities through appropriate electronic systems
- Involvement in filter selection and sizing, process optimization, and technology transfer activities associated with the purification of new pharmaceuticals
- Proficiently document customer interfacing activities
7
Responsibilities For Fill Finish Process Development Scientist AS Resume
- Optimization of process improvement to increase pass rate, efficiency, and implementing process changes
- Implementation of operating plans and strategies to improved TAT and on-time delivery
- Prepare reagents and cell culture media using aseptic technique
- Full clean driving licence required to facilitate travel
- Masters or PhD in a Science or Engineering or related discipline
- Knowledge of established genome editing technologies is desirable
8
Responsibilities For Biologics Process Development Scientist Resume
- Proficiency in multiple programing languages, with emphasis on SQL, VBA, Python, or R
- Familiarity with other process development areas, including drug substance, analytical, device and container development
- Knowledge of cellular therapy, T cell biology and the current CAR T manufacturing process
- The flexibility to work in a team-oriented or independent environment depending on project needs
- Educational background in Engineering and/or Life Sciences
- Expertise in food process technologies and engineering principles relevant to process development and scale-up
9
Responsibilities For Principal Process Development Scientist Resume
- Work in a laboratory setting
- Master’s in chemistry, chemical engineering or related field
- Participate in long range business analyses and planning
- Inorganic treatment of aqueous wastewaters, including ion exchange, evaporation and related separations
- Function in a rapidly changing environment
10
Responsibilities For Process Development Scientist, Sequencing Resume
- Apply rigorous attention to detail when executing experimental protocols
- Perform all process steps and to guide manufacturing on the operation of all process steps
- Balanced understanding of all areas of chemistry
- Provide support to commercial operations on a day to day basis (Change control assessments, product impact assessments, document revisions, etc.)
- Apply advanced technical principles, theories, and concepts in the development of new principles and concepts
- Conceive plans and conduct scientific research/investigation in areas of considerable scope and complexity
- Perform work that involves in-depth investigation of subject area, definition of scope, selection of areas of investigation, and development of novel concepts
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