R&d Scientist, Test Method Development

3 months ago

Cape Town, South Africa Watchmaker Genomics Full time

**Position**: R&D Scientist, Test Method Development

**Position Type**: Full-Time Employee

**Department**: Research and Development

**Location**: Cape Town, South Africa, onsite

**Experience**: A PhD in Biochemistry, Molecular Biology, Chemistry, or MSc with 3+ years of relevant test method development and validation experience

**Position Summary**

**Key Responsibilities**
- Lead test method activities throughout the Product Life Cycle, from development to continuous improvement.
- Collaborate with key stakeholders to define and implement test method development and validation strategies.
- Work with R&D and Production teams to develop and transfer test methods, including defining critical parameters and mitigating risks.
- Manage and execute projects focused on test method development and validation, ensuring that robust methods are transferred to Production.
- Design statistically powered test method validation studies.
- Analyse data using advanced statistical methods.
- Communicate results and provide guidance on product specifications.
- Train Quality Control analysts on test methods, laboratory procedures, and quality systems, including good documentation practices and data review.
- Contribute to validation activities, including process validation, computer systems validation, and equipment qualification.
- Identify and implement test method requirements, such as materials, equipment, software, and facilities design.
- Conduct experiments with scientific rigour and accurately record, communicate, and present findings.
- Support laboratory maintenance, including ordering materials, maintaining equipment, and ensuring a clean and organised lab.
- Operate under Watchmaker's Quality System, contributing to the implementation and adherence to ISO13485 standards, including leading non-conformance and corrective action investigations.

**Skills and Requirements**
- Proven experience in test method development and validation for biotechnology reagents.
- Expertise in statistical tools, including Design of Experiments (DOE), Statistical Process Control (SPC), Regression Analysis, Analysis of Variance (ANOVA), and Gage Repeatability & Reproducibility (Gage R&R).
- Strong understanding of data models, manipulations, and analyses, including descriptive statistics, parametric and non-parametric approaches, and data visualisation.
- Experience with ISO 13485, ISO 9001, and/or cGMP in Test Method Development, Quality Assurance, Quality Systems, Operations, or related fields.
- Broad technical knowledge of life science reagents, genomics, next-generation sequencing (NGS), PCR, and/or recombinant protein production is highly desirable.
- Demonstrated scientific excellence in technical work, written communication, and presenting technical information to diverse audiences.
- Ability to multitask, perform under pressure, and work independently.
- Strong interpersonal skills with a proven ability to drive results in cross-functional teams.
- Exceptional organisational skills and attention to detail.
- Strong written and verbal communication skills.

**Education and Experience**
- PhD in Biochemistry, Molecular Biology, Chemistry, or Statistics **OR **MSc with 3+ years of relevant experience in test method development and validation.

**Application Requirements**
- Letter of motivation (upload where it says cover letter)
- Resume or _Curriculum vitae_, highlighting relevant qualifications and experience

If selected to participate in the interview process, the names and contact information of three professional references who are able to assess your suitability for the position in terms of the specified requirements will be requested.
- **_

**_ 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._
- All applicants will be asked if currently eligible to work in South Africa; and if now or in the future will require visa sponsorship to continue working in South Africa._

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