Process Development Job Description
Process development
provides technical support and lead troubleshooting of commercial drug substance manufacturing processes across cell culture and purification disciplines.
Process Development Duties & Responsibilities
To write an effective process development job description, begin by listing detailed duties, responsibilities and expectations. We have included process development job description templates that you can modify and use.
Sample responsibilities for this position include:
Optimize manufacturing processes in capability / reliability /capacity/ de-bottlenecking
A strong track record working closely with process development scientists to establish efficient clinical and commercial manufacturing processes
Work closely together in cross functional teams with PE tooling development & support, and the PE training team to ensure alignment within PE
Work closely together with other engineers and technicians across the organization to ensure stable production processes
Lead the process development component of the Commercial Readiness Team to ensure facility and processes are ready for Phase III / Commercial production
Develop process understanding to support the scale up of biological processes, perform gap analysis to identify key process parameters and equipment needs to facilitate process transfer into manufacturing
Support the development of a strong and robust Technology Transfer process (both Internal and External) to support both clinical and late phase production
Support the authoring of Process Descriptions and Batch Records, support equipment, commissioning, process training, and validation activities
Lead facility fit activities for existing and future internally and externally transferred processes
Identify best practices and drive adoption into manufacturing group to improve clinical and commercial production processes
Process Development Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Process Development
List any licenses or certifications required by the position: LSSBB, PMP, CLD, DFSS, ISPE, HIPAA, RSS, LEAN, DOE, SPC
Education for Process Development
Typically a job would require a certain level of education.
Employers hiring for the process development job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Chemistry, Chemical Engineering, Manufacturing, Technical, Education, Mechanical Engineering, Physics, Biochemistry
Skills for Process Development
Desired skills for process development include:
Manufacturing processes
New developments in manufacturing and design technologies
CGMP
Materials
Product and process design
High reliability
Drug Substance
Excel
CGMPs
High volume manufacturing processes and designs
Desired experience for process development includes:
3-5 years’ experience within a regulated R+D / manufacturing environment
Ability to communicate, engage and partner with all levels of the organization from operator to the executive level
Provide process equipment troubleshooting to resolve issues that may arise during a manufacturing campaign
Perform batch record, solution record and deviation reviews
Support technical deviation investigations and collaborate with Operations and Quality teams to determine the impact, root cause, and corrective actions for the deviation
Support the development of a process characterization group to support Phase III/Commercial production
Process Development Examples
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Process Development Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of process development. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for process development
- Secure that Process Development is involved and contributing to the Technology ambitions for the future
- Previous product development experience with a CPG company
- Demonstrated entrepreneurial spirit
- Documents experiments, results and findings in electronic laboratory notebook
- Identify and manage strategic and generic process technology problems across a high hazard chemical manufacturing site to improve current plant operations and maximise capacity
- Investigate and develop new process technologies to reduce costs of production
- Plan and manage short term project
- Provide support to the production department in quality and performance investigations across the site
- Propose modifications to the process to improve Process safety, site EHS and environmental footprint
- Evaluate improvement proposals presented by Production and provide clear and concise advice on their feasibility and interest aligned with site strategy and goals
Qualifications for process development
- Must be willing to work overtime depending on business demands
- Must be willing to travel internationally (up to 25%) depending on corporate business demands
- Ability to persuade, influence and collaborate with others to achieve common organizational goals
- Demonstrate functional, technical and people and/or process management skills customer relationship skills?
- Manages resources for relevant client projects and reviews and updates CT Development resource planning tool for relevant projects and direct reports
- Effectively identify and escalate process risks, prepare project progress summaries for management review and develop and manage project timelines
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Process Development Job Description
Job Description Example
Our innovative and growing company is hiring for a process development. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for process development
- Act as a liaison with inter-company departments
- Taking part in cross functional team projects
- Working within larger production group to ensure production meets all specifications and regulatory compliance
- Bring passion to your role as a development engineer who will become an expert with activation and thermal processing, to create adsorption media for existing market applications and future customer needs
- Communicate results through monthly reports, technical memos, and presentations to a variety of audiences and stakeholders
- Balance multiple project priorities, apply practicality, assure flexibility, and pitch in as needed to help
- Become a cohesive member of our team, treating people with respect and listening openly to their ideas and opinions
- Perform duties as directed in whatever area of manufacturing operations they are currently assigned to
- Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services
- Review and interpret data to make recommendations on immediate actions, long term corrective actions, follow-up experiments
Qualifications for process development
- Relevant experience within industrial engineering environment
- Industrial plastic molding processes knowledge / experience is an asset
- Proven project management knowledge and experience
- Capability of handling complex problem solving matters and action driven
- Effective communication, customer focus and standing alone skills
- Strong technical capability on both chemistry and chemical engineering discovering for new process
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Process Development Job Description
Job Description Example
Our company is looking for a process development. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for process development
- Design of experiment and statistical analysis to make data driven decisions around implementation of new processes or materials
- Perform experiments for the group based on the PD group priority
- Works well with other PD technicians and Engineers to ensure that the experiment are done in a very safe and efficient manner
- Develops work instructions or provide feedback on improving the work instructions
- Able to specify parts and equipments for building an experimental set-up, under the guidance of a Sr PD Technician or PD Engineer
- Participate in hazard analysis of a proposed experimental system and implement recommendations of the PHA team
- Document experimental observations carefully and be able to do simple mass balance calculations
- Characterize the mechanical material properties of commonly used pharmaceutical excipients using a DMA
- Design and fabricate necessary mechanical fixtures for material characterization
- Write technical reports and deliver presentations to the group
Qualifications for process development
- Evaluate capability of rolling mills to meet customer quality requirements, including gauge, width, shape and surface quality
- Works in a multi-disciplinary environment with Operating, Metallurgical, Engineering and Maintenance personnel, and provides technical support for product development activities and problem solving product quality issues
- Performs in-depth statistical data analyses, summarizes information into graphical and tabular formats, prepares technical reports and presentations
- Assists with technical training of mill operators
- Represents the company in industry and university consortium activities
- Develop electronics packaging production processes such as wire bonding, die attach, vacuum reflow soldering, dicing, etching, potting, curing, etc
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Process Development Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of process development. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for process development
- Responsibly handle and provide oversight during processing of DEA controlled substances
- Develops various wafer process steps including photolithography, wet and dry etching, PECVD, metal deposition, and plating
- Responsible for basic maintenance and calibration of production machines including mask aligner, hot plates, oven, PECVD, E-beam evaporator, thermal processing, and various pumps
- Real-time production problem management including coordinating customer calls, problem escalation to appropriate support levels, tracking, and follow up
- SME for all order flow and provisioning enhancements and/or changes
- Works closely with IT teams to ensure all changes are tested prior to being implemented in production
- Working closely with Engineering, Operations, and IT to ensure we gather, develop, and deliver requirements to exceed customer expectations from POS to Fulfillment
- Coordinated and regular communications/updates with the impacted teams on project status
- Development of M&P’s and analysis support areas
- Supervisory responsibilities for up to five direct reports
Qualifications for process development
- Knowledge of new state-of-the-art devices such as SiC JFETs, MOSFETs, TMOS, thyristors, Schottky Diodes
- Degree in Chemical or Biochemical Engineering is strongly preferred
- A deep and fundamental understanding of biochemical engineering principles (e.g., sterile operations, aeration and mass transfer, bioprocess control), in particular, at large scale, is essential
- Minimum 10 years’ experience in an operating fermentation or chemical processing plant with a strong track record of delivering results is required
- Experience in optimizing and scaling up industrial biological and chemical processes is expected
- Besides a strong background in fermentation and/or biochemical processing, additional experience with downstream purification processes
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Process Development Job Description
Job Description Example
Our innovative and growing company is hiring for a process development. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for process development
- You identify and analyse opportunities to optimise or improve processes and products of the BL by applying scientific, technical and financial metrics
- You work out ideas and set up the necessary tests either in house, or with a carefully selected partner, in order to verify the validity
- You absorb innovative techniques and generate pioneering ideas for further development
- You build up an international network within the BU structure and with Group Research & Development in order to share expertise with colleagues
- You broaden your expertise and process and product knowledge by attending seminars, congresses, visiting suppliers and customers
- Understand market and industry roadmaps to develop advanced cleaning technologies ahead of the requirements
- Support new product introduction through serving as a technical member on assigned product development projects
- Support the pre-pilot production of new products and alpha samples to key customers
- Design of new equipment to support new processes including creation of functional specification, P&ID’s, and equipment specs
- Implement efficiency improvements for existing processes including reductions in cycle time, chemical and water usage, and process variation
Qualifications for process development
- Mentoring direct reports colleagues is an essential component of the responsibilities
- Knowledge of statistics, data analysis, ‘design of experiments’ is highly desired
- Sit or stand for long periods, bending and kneeling
- Produce high quality deliverables for clinical research
- Coordinate equipment calibration & Preventative Maintenance in the area of responsibility
- BS/MS in Electrical Engineering, Mechanical Engineering, Optics, or other technical field