Process Development Resume Sample

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Mikel Hansen
52042 Stark Orchard,  Philadelphia, PA
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Work Experience


Process Development Associate
05/2015 - PRESENT
Houston, TX
  • Experience within the pharmaceutical sector of formulation development, process development and optimization or technology transfer
  • More than 7 years’ experience of practical application in Product/Process Development within Food industry. Experience in confectionery is a strong advantage
  • Develop, test and implement new methods and technologies to optimize organotypic manufacturing processes for a pipeline of cell-based tissue therapies
  • Develop, test and implement new methods and technologies to increase process scale and improve product quality, throughput and cost per unit
  • Assist with design, implementation and maintenance of production equipment
  • Draft operating procedures for processes and equipment
  • Train other personnel on operating procedures for processes and equipment
Process Development Technician
07/2010 - 11/2014
Houston, TX
  • Oversee aspects of the day to day functioning of the Pilot Plant and be a first point of contact for any alarms/malfunctions within the Gas House & Storage Oven facilities
  • Complete any process safety risk assessments for Pilot Plant experiments for management approval, applying any relevant safety in manufacturing legislation
  • Support the Process Development Manager and Technical Project Leaders on multiple projects including innovation, renovation, Digital, value and quality improvement
  • Technical project scoping to include experimental design and utilization of Unilever’s product management systems, including delivery of functional process designs, process flow diagrams & specifications
  • Work closely with Chefs, product technologists, other R&D capabilities, and other functions to deliver process and product prototypes
  • Lead supplier relationships, working closely supply chain and factories, to develop new products formats, processes, control systems, data acquisition systems
  • Organizing and managing pilot plant trials or industrial trials in the various factories involved
  • Experienced in protein and/or viral particle purification methods that include cell culture supernatant harvest and clarification, column/membrane chromatography, filtration technologies (UF/DF, Dead-end, etc.)
  • Perform assays and develop methods in support of viral vector characterization (ELISA, Flow Cytometry, qPCR, Western-blot, HPLC, Particle analysis, etc.)
R&D Process Development Intern
12/2007 - 03/2010
Boston, MA
  • Mat assist in implementing cGMP procedures for regenerative medicine advanced cell therapies
  • Demonstrated proficiency in the use of laboratory techniques, equipment and materials
  • Demonstrated ability to improve instructions or correct a previously unknown problem with instructions
  • Problem solve: investigate alternate process routes/ ingredient interactions, interpret data & if required liaise with Process Science colleagues
  • Write Main Plant Trial Batch Sheets/Process Flow Diagrams (PFD), for management approval, assisting/Supervising of MPT’s when required
  • Accurately prepare Deodorant product samples at bench & pilot scale for trade list registration, specification & consumer tests
  • Assist/Resolve processing issues within Manufacturing/ Supply Chain
  • Through process experimentation support raw material qualification, raw material, product & process specifications

Education


Siena Heights University
2002 - 2006
Engineer's Degree in Engineering

Professional Skills


  • Excellent written and oral communication skills, interpersonal skills and ability to effectively work as part of a team required
  • Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing programs/projects and priorities
  • Excellent organizational skills and the ability to effectively prioritize
  • Possesses strong attention to detail, ability to maintain accurate records and excellent proofreading skills
  • Excellent communication, networking and team working skills
  • Excellent project management, planning and organisation skills
  • Be self-motivated with strong problem solving skills and a willingness to learn and develop yourself and others

How to write Process Development Resume

Process Development role is responsible for organizational, analytical, interpersonal, software, leadership, planning, development, documentation, microsoft, computer.
To write great resume for process development job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Process Development Resume

The section contact information is important in your 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
  • Email
  • Telephone number

Work Experience in Your Process Development Resume

The section work experience is an essential part of your 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 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 process development position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative Process Development resume experience can include:

  • Excellent written, oral communication skills to align with development, operations and partner teams. 30% traveling in Asia
  • Strong analytical skills, problem-solving ability, and innovation aptitude required
  • Strong interpersonal skills to “make things happen”
  • Good analytical and process flow skills
  • Excellent verbal and written communication skills, and record keeping abilities to accurately record, analyze, and document development data generated
  • Strong written and verbal communication skills along with the ability to work independently and on multidisciplinary teams are essential

Education on a Process Development Resume

Make sure to make education a priority on your 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 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 Process Development Resume

When listing skills on your 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 process development skills:

  • Good communication skills, good English in written and verbal (German is advantage)
  • Good organizational, meeting planning coordination and project management skills
  • Strong planning, influencing and project management skills
  • Clear thinker and communicator with good analytical and planning skills
  • Excellent practical and problem-solving skills
  • Strong analytical skills, problem solving ability, and innovation aptitude required

List of Typical Experience For a Process Development Resume

1

Experience For Process Development Associate Resume

  • Skill in identifying, developing, and delivering technical training. Skill in project management
  • Superb documentation and organizational skills, often providing summaries and generating development reports
  • Highly skilled in prioritizing multiple tasks and deliver tasks on time and manage expectations
  • Jecho offers a competitive salary (commensurate with experience) and excellent benefits package
  • Proven supervisory or management experience to lead assigned process development staff
  • BS or MS in Chemical Engineering or Bio-related Engineering with 0-2 years of experience in a laboratory setting
  • BS in Chemical Engineering or Bio-related Engineering with 0-2 years of experience in a laboratory setting
2

Experience For Process Development Technician Resume

  • Executes effective and efficient planning, management and reporting of all factory trials relating to NPD, Procurement, and Continuous Improvement initiatives
  • Co-ordinating and prioritising system change activity across the group’s facilities
  • Experience working with a diverse team including lab technicians, chemist, production, and logistics personnel
  • BS. in Chemical Engineering, Biochemical Engineering, Life Sciences with 1+ years experience in biotech/pharmaceutical industry
  • Use Microsoft Excel, Word, PowerPoint, and understand basic engineering drawings (e.g. AutoCAD, SolidWorks, etc.)
  • Experience working in a cross-functional, peer-based, organization
  • Contribute to lab equipment maintenance and safety to help create a safe, effective and efficient working environment
3

Experience For Process Development Manager Resume

  • Experience in materials used for molding of electronic devices
  • Experience in molding tools design/modifications wrt package requirements
  • Experience in molding process from diff technology, materials and equipments
  • Operates in a determined and purposeful manner and is tenacious at achieving goals
  • Perform purification processing runs to make purified material for characterization/formulation and to qualify/validate assembled purification processes
  • Ensure machine downtime is minimized and safety concerns are closed out as a top priority. Products are delivered to the customers according to schedule
  • 0-3 yrs. relative experience
  • Pharmaceutical or Biotechnology industry experience required
  • Write and prepare technical reports, qualifications and validations
4

Experience For Process Development Technologist Resume

  • To evaluate process technology development procedure to achieve strategic imperatives and improve cost effectiveness
  • Write and prepare technical reports, manufacturing procedures, qualifications and validations
  • Demonstrates exemplary stakeholder engagement capability
  • Senior level industry experience in global, medium-size pharmaceutical development or research entities or CRO
  • Demonstrate ability to think creatively and to apply these ideas during technical development
  • Proven ability to flourish in a lean, hand on, practical environment
  • One year of industry laboratory experience required
  • Assess process capabilities, prioritize process improvement opportunities, and innovate and implement process improvements on commercial products
5

Experience For Process Development Engineering Technician Resume

  • Write and review validation protocols and report applicable to new processes
  • Industry experience, preferably in a commercial environment
  • Operates and maintains standard laboratory equipment and departmental specific laboratory equipment
  • Laboratory or chemical manufacturing experience is required
  • Exceptional and visionary leadership with a focus on building strong and productive teams
  • Manufacturing/plant operations experience
  • Experience in manufacturing management in a technical shop environment
6

Experience For Process Development Specialist Resume

  • BS in Engineering desired (Additional equivalent experience could replace a portion of the educational requirement.)
  • Strong ‘hands-on’ Technical knowledge of food manufacturing processes
  • Demonstrated success in implementation of Continuous Improvement and change projects within a food manufacturing environment
  • Experience with geometric tolerancing is also desirable
  • A good understanding of recombinant biological product expression and purification mechanism and basic protein analysis
  • Skillful on basic computer software including Excel, word and PowerPoint
7

Experience For Product / Process Development Manager Resume

  • Good technical knowledge of production, assembly and testing processes
  • Experience in automated assembly techniques
  • Demonstrate commitment to cGMP, EHS compliance aspects of clean-room plant operation
  • Related industry experience
  • Experience in a biotechnology laboratory
8

Experience For Manager Aftermarket Systems & Process Development Resume

  • Tatistical process control experience and/or statistics
  • Supporting necessary configuration changes through the process of development, testing, deploying and documenting
  • Authoring documentation and providing on-site support for process transfer to Regeneron's
  • Working knowledge of data analysis systems e.g.: Y3 and JMP to facilitate analysis of experimental data. Working knowledge of Design of Experiments (DoE)
  • Creating and implementating process and product qualification (IQ, OQ, PQ)
9

Experience For Process Development Co-ordinator Resume

  • Identifying gaps/areas for improvement and propose new process/system re-design to improve operational efficiency, working closely with Continuous Improvement
  • Conducting studies and process mapping
  • Purifying/Conjugating proteins for use in Quality Control and Attribute Sciences
  • Maintaining total ownership of the wire drawing process parameters and performs daily checks to ensure process stability
  • Developing appropriate analytics for in-process testing
10

Experience For Process Development Engineering Manager Resume

  • Identifying and suggesting proactive solutions to known equipment risks
  • Understanding of various integration/structural impacts and constraints related to Wet processes
  • Participating in the development and support of Shelby’s distribution
  • Acting as a liaison for our distribution tools
  • Developing ad hoc reports and analyze them to gain insight and to support projects
  • Managing projects to completion by their established completion dates

List of Typical Skills For a Process Development Resume

1

Skills For Process Development Associate Resume

  • Strong analytical skills with knowledge of Lean and Six Sigma
  • Excellent communication skills with the ability work with stakeholders at all levels
  • Excellent communication, facilitation, teamwork and change management skills
  • Excellent written communication and leadership skills and attention to details
  • Previous antibody conjugation skills and experience
  • Motivated self starter with excellent interpersonal and organizational skills
  • Work as a team player and/or independently with good interpersonal skills
  • Strong multifunctional team leadership skills
2

Skills For Process Development Technician Resume

  • Good analytical skills to convert business objectives in to achievable tasks
  • Strong written and verbal communication skills with a keen eye for detail
  • Outstanding interpersonal, teaching and leadership skills
  • Leaving Cert and/or 3 years Pharma Experience in a modern solid oral dosage pharmaceutical environment (or related industry)
  • Responsible for maintaining compliance of site validation master plan to current good manufacturing practice requirements
  • Experience in method validation and technical writing
  • 5 – 8 years of relevant work experience, including team leadership experience, required
  • Responsible for process validation to meet current good manufacturing practice
  • Responsible for software validation to meet current good manufacturing practice
3

Skills For Process Development Manager Resume

  • Proven ability to work in a demanding & dynamic environment and able to prioritize and manage multiple projects simultaneously
  • Demonstrable experience in a senior leadership role with experience of managing people through influence across department and various levels of leadership
  • Demonstrated previous experience with cell therapy products including viral vector production is required
  • Facilitator Skills: Facilitate multiple teams, Facilitate team meetings, and Practicing Facilitative Leader
  • Experience in a Technical role in another blue-chip Fast-Moving Consumer Goods (FMCG) company is desirable
4

Skills For Process Development Technologist Resume

  • Demonstrated experience with mechanical problem solving
  • Strong experience of training requirements within a highly regulated environment
  • Lean Practitioner Skills: Conducts Lean Process Improvement events with minimal support
  • Computer skills - Microsoft Office and other systems
  • Work effectively as a cross-functional team member
  • BS/BA in life sciences and 3+ years of fermentation and/or microbial downstream processing experience. Or equivalent level of experience and education
5

Skills For Process Development Engineering Technician Resume

  • Highly organized with efficient time management skills
  • High levels of integrity, confidence, independence and collaboration skills
  • An ability to effectively manage change
  • Strong industrial background with experience in process development and scale-up
  • Effectively communicate technical findings to internal stakeholders
  • Managerial experience directly managing people and/or leadership experience leading matrix teams, projects or programs
6

Skills For Process Development Specialist Resume

  • Perform engineering tests and process validations. Compile and organize data to support the generation of engineering test and validation reports
  • Perform engineering builds, tests, and process validations. Compile and organize data to support the generation of engineering test and validation reports
  • Demonstrated experience with successful scale-up of developed processes for clinical and commercial GMP operations
  • Demonstrated experience with experimental design and execution and data interpretation to facilitate a Quality by Design (QbD) approach to development
  • Skills in statistics and statistical analyses of data from designed experiments
  • Understanding of Good Manufacturing Practice (GMP)
  • Tabletting experience is an advantage
7

Skills For Product / Process Development Manager Resume

  • Working, solid knowledge of primary science and engineering principles required
  • Grinding and machining practices of tooling steel experience
  • Experience developing, qualifying , and troubleshooting assays and analytical methods in GxP environments
  • Leading cross functional disciplines or projects including stakeholder management, prioritization, decision-making frameworks and resource influence
  • Experienced in managing, restructuring and change managing teams affected by process changes and tech developments
  • Strong working knowledge of engineering, food science, food manufacturing processes, quality assurance principles, statistics and SPC
  • An ability to demonstrate a thorough approach to reasoning and problem solving
  • Relevant experience including process (re)-engineering and change management practice
  • Demonstrate and instruct proper gowning and aseptic processing procedures
8

Skills For Manager Aftermarket Systems & Process Development Resume

  • Industry experience working in a cGMP biomanufacturing environment
  • Experience mentoring and developing people leaders
  • Possesses strong business acumen and learning agility
  • Completes all documentation in accordance or very close to current Good Manufacturing Practices (cGMP) and imMEDIAte ADVANTAGETM procedures
  • Experience in process development, manufacturing of combination products
  • Excellent manufacturing process technology acumen, especially within platform family
  • Quickly establish credibility and build trust with a demonstrated history of gaining cross-functional and cross-cultural alignment
9

Skills For Process Development Co-ordinator Resume

  • Experience in capital planning and acquisition
  • Experience working in a Semiconductor, medical device or military spec production operation
  • Practical experience in Factory Processing or Laboratory environments
  • Focused experience in a particular field (e.g. Rheology, Processing of a formulation technology)
  • Combined experience in forest product or chemical manufacturing process, technical service, or R&D
  • Manufacturing experience in a GMP or other regulated environment is required
  • Experience in a GMP manufacturing environment is desired
  • Technician level experience in process equipment support, investigations, and problem solving
10

Skills For Process Development Engineering Manager Resume

  • Maintain a lab with excellent housekeeping
  • Demonstrated strength with trouble-shooting activities
  • Respond positively and flexibly to changing priorities to ensure desired outcomes
  • Project management ability, including excellent communication and leadership ability
  • Experience in multi-faceted research planning and design
  • Flexibility to operate in a rapidly changing environment
  • Strong work ethic and show self-initiative starting tasks
  • Process engineering, project management, and implementation experience

List of Typical Responsibilities For a Process Development Resume

1

Responsibilities For Process Development Associate Resume

  • Effective oral and written skills and a good practical knowledge of the laboratory environment
  • A strong fundamental understanding of various protein purification techniques
  • Be accountable for Process development, Registration stability and scale up activities leading to Process Validation
  • Indirect management of our operational teams (shared service centers) to ensure that their committed service offering is maintained for the EMEA goods business
  • Experience using CAD and APQP
  • Solid technical background in process development and scale up
2

Responsibilities For Process Development Technician Resume

  • Zero to two (0-2) years of relevant experience in a process development environment
  • Experience in the assembly and maintenance of high accuracy electro-mechanical process equipment
  • Use a data acquisition and control system to operate equipment and complete process trials
  • Make suggestions to improve the efficiency and effectiveness of the experimental systems and group
  • Experience designing precision tolerance components
  • Demonstrated ability to work and collaborate in cross functional teams, research, development, manufacturing in a fast pace, dynamic team setting
  • Experience of driving & motivate teams to meet aggressive timelines and deliverables
3

Responsibilities For Process Development Manager Resume

  • Process development experience
  • Operate and troubleshoot production equipment in assigned area and report unusual conditions or concerns about the process or equipment to area Supervisor
  • Time served apprenticeship or equivalent production experience
  • Operate and maintains automated laboratory equipment to complete investigations
  • Ongoing input regarding quality process improvements
  • Delivering new product grid in partnership with Global Technical Centers
  • Delivering on operational projects outlined for the year
  • Collaborating with outside groups as needed
  • Reporting issues or process deviations to the on-shift engineers and/or manager
4

Responsibilities For Process Development Technologist Resume

  • Understanding of various integration and structural impacts and constraints related to film deposition processes
  • Working knowledge of data analysis systems e.g.: JMP to facilitate analysis of experimental data
  • Building of rigs and tooling with a mechanical, electronics and controls content
  • Testing of new equipment to ensure functional requirements are met
  • Responsible for providing ongoing coaching and feedback and conducting performance reviews for direct reports
  • High standards for working safely, including proper storage, labeling, and use of chemicals, compliance with safe work practices and policies, and housekeeping
  • MS or PhD. in Biochemical Engineering, Chemical Engineering or related Scientific/ Engineering field required
  • Manage all documentation and records associated with pilot scale manufacture, ensuring accurate recording of all work and appropriate filing and storage
5

Responsibilities For Process Development Engineering Technician Resume

  • Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment
  • Responsible for the creation and transfer of manufacturing processes from R&D to Manufacturing and continuous improvement of existing processes
  • Conduct regular check-in’s to analyze current state including understanding customer satisfaction, both internally and externally
  • Assist in the procurement of new testing and manufacturing equipment
  • Conduct testing on application specific geometries simulating end-use conditions
  • Responsible for setting annual goals and objectives and long range planning of the business unit
  • Responsibilities can also include acting as the lead manufacturing engineer assigned to product development projects
  • Thorough understanding of raw material requirements for GMP processing is required
  • Utilize creative thinking and “out-side-the-box” problem solving to overcome obstacles
6

Responsibilities For Process Development Specialist Resume

  • Utilize creative thinking and “outside-the-box” problem solving to overcome challenges
  • Responsible for keeping training current
  • Champions innovation to drive a change from traditional batch processing to continuous processing
  • Assist with the dialing monitoring and analysis of cell cultures and other experiments as needed
  • Lead the strategy and scientific design in developing platform manufacturing processes across Amicus portfolio
  • Oversee technology and manufacturing process transfer, providing product for applicable clinical trials as required
  • Perform mammalian cell culture activities such as transfection, selection, clone screening and cell banking
7

Responsibilities For Product / Process Development Manager Resume

  • Supervises Process Control for all processes used to manufacture Spring Wire and Welding Wire
  • Develops and Organizes Wire Drawing routes, Die series and handling techniques for new Grade Types
  • Provides Technical Support for existing and new business opportunities including Q.A and Materials matters
  • Follows and accurately completes manufacturing working batch records
  • Follows all relevant Standard Operating Procedures (SOP’s), CoSHH and Risk Assessments to allow for compliant and safe working practices
8

Responsibilities For Manager Aftermarket Systems & Process Development Resume

  • Assist in organising Idea Generation Session and delivering of Cost Savings – Squeeze projects
  • Systematically process biological samples for multiple projects using cutting edge genomic technologies
  • Familiarity with cGMP, manufacturing, machine operations, aseptic technique and data entry
  • Initiative, creativity and problem solving abilities
  • Plan and manage short term project (e.g. generic problem solving for site) and long term projects (e.g. development of novel process routes)
  • Create the testing methodologies and apparatus to evaluate product and process performance
  • Execute studies supporting the development of new process/ product specifications
9

Responsibilities For Process Development Co-ordinator Resume

  • NVQ3 or NC level in an engineering subject
  • Handle maintenance utilizing the shop as needed
  • Test alternative equipment and operating conditions in order to develop a better model of plant equipment
  • Design test geometries, jigs, fixtures and tooling to support application development with SABIC resins
  • Responsible for developing current operational processes to reduce supply risk and increase efficiency
  • Responsible for maintaining waste reduction funnel and scorecard within operations
10

Responsibilities For Process Development Engineering Manager Resume

  • To support Manufacturing Manager through deputisation and associated activities
  • Support EHS framework and assist in annual planning, implementation, evaluation and review
  • Act as main manufacturing resource for pilot scale (3kg-60kg) manufacture of new Body Care products
  • Ensure timely supply of raw materials for Body Care making needs, and maintain inventory of key materials to enable responsiveness
  • Participate in the selection and evaluation of new equipment for existing facilities
  • Plan and manage benchmarking and other competitive research activities; analyze and communicate results
  • Instrumental in the development and planning stages of uncharted and complex research goals
  • Responsible for defining collaborative projects with FUJIFILM Diosynth Biotechnologies U.K

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