Process Development Scientist I

This position reports to the Process Development Lead and will be responsible for the design, improvement and technical transfer of manufacturing filling & assembly processes from R&D into Production. This is a highly collaborative position that involves working closely with members of other departments such as R&D, Manufacturing, Marketing, Quality Control and Quality Assurance.

**Responsibilities**
- Drive the design & implementation of the following processes:

- Filling and labeling of vials
- Product assembly, packaging and shipping
- Generating product documentation such as certificates of analysis, safety data sheets and user guides
- Label template design, and system integration with labeling equipment and software
- Effective in-process checks that meet quality standards
- Drive manufacturing process design-related activities throughout the Product Life Cycle including product development and continuous improvement
- Collaborate with R&D and Production to develop and transfer processes, including defining critical process parameters and identifying and mitigating risks
- Identify and drive implementation of Production requirements such as materials, equipment, software, instructions as well as advise on facilities design
- Independently design, optimize and implement new and existing processes while maintaining compliance to procedures
- Author, revise and publish relevant documentation such as work instructions, batch record templates, risk analyses and project reports
- Train relevant users in new and revised processes
- Lead and/or contribute to projects with cross-functional teams
- Contribute to the planning and execution of validation activities such as process validation, computer systems validation and equipment qualification
- Design, execute and record experiments with scientific rigor
- Analyze and interpret experimental results including graphing and statistical analysis
- Record, communicate and present findings with accuracy and clarity
- Contribute to laboratory maintenance including ordering of raw materials, maintaining equipment and cleaning/organizing the lab
- Other duties as assigned

**Skills and Requirements**

The following skills and experience would be advantageous for the position:

- Experience in process development and implementation for reagent manufacturing specifically for vialing and assembly of finished goods
- Demonstrated ability to design and monitor processes using statistical methods such as Design of Experiments (DOE), Statistical Process Control (SPC), Regression Analysis, Analysis of Variance (ANOVA) and Gage Repeatability & Reproducibility (Gage R&R)
- Experience with production-related systems such as: Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES) and Laboratory Information Management Systems (LIMS)
- Experience planning, executing and reporting on validation activities including process validation, computer systems validation and/or equipment qualification
- Broad technical knowledge of life science reagents, genomics, next-generation sequencing (NGS), PCR and recombinant protein production are all highly desirable
- Familiarity with ISO9001 and/or ISO13485 standards or operating within a structured quality management system (QMS)
- Demonstrated scientific excellence in technical work, written communication and presenting technical information to groups with various scientific backgrounds
- The ability to multitask, perform consistently under pressure and work without supervision
- Strong interpersonal skills and an excellent ability to drive results in multi-level, cross-functional teams
- Excellent organizational skills and outstanding attention to detail
- Good communication and personal task management skills and a high level of self-motivation
- Ability to determine project timelines and meet deadlines
- Excellent written and verbal communication skills

**Education**
- Minimum qualifications equivalent to MSc in molecular biology, biochemistry or BEng Hons in engineering or a related discipline is required
- A minimum of 3 years in biotech or related industry, including positions with broad functional scope across research and development, technical transfers, manufacturing, quality control, and quality assurance

**Application Procedure**
- Letter of motivation
- **_
- WE ARE AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER_
- Watchmaker Genomics is committed to being an equal opportunity employer and creating a culturally diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics as protected by applicable law._

**Job Types**: Full-time, Permanent