Senior Consultant (Manufacturing Sciences And Technology)

About Valgenesis:

We’re a rapidly growing global SaaS company that helps life-science organizations bring lifesaving products to market with increased quality and reduced ecological impact. Our customers include 30 of the top 50 global pharma and biotech companies. We lead our market through innovation and by delivering value over web, mobile, IOT, AR channels and consulting services.

Role Summary:

ValGenesis seeks to expand its recently incorporated Consulting Services Organization via the recruitment of a Product Lifecycle Management (PLCM) Associate Consultant. If you have a technical background on pharma and/or biopharma industry (e.g. process development, technology transfer, manufacturing, manufacturing sciences and technologies, etc.) and have a desire to continue to develop your CMC technical expertise, supporting pharma and biopharma companies worldwide on their product lifecycle management efforts, this will be an exciting opportunity for you. We provide niche consulting in the following, but not limited, areas:

• Process development support
• Application of Machine Leaning solutions for early phase drug screening
• Wokplace type: Hybrid or Remote
• PAT implementation
• Supporting Locations: Noth America (primarily)
• Process Optimization and Troubleshooting
• Process Modelling
• Digital Twins
• Scale-up and Technology Transfer

Key Responsabilities:

• Deliver a culture of problem solving and learning within Consulting Services
• Prepare and deliver scientific and/or technical articles and/or white papers.
• Produce materials for internal training courses or public presentations.
• Prepare and deliver technical/ scientific presentations in key industry conferences.
• Collect data for the construction of predictive models based on pharma and biopharma process and product data.
• Contribute to the improvement of customer’s manufacturing processes, technologies and control strategies within biopharma and pharma landscape.
• Ensure flawless and sound technical execution of projects rooted in quality, continuous improvement, guided by the desire to solve difficult problems that maximize customer value.
• Liaise with the top players of the pharma and/or biopharma industry on the execution and delivery of a wide range of multidisciplinary projects in the area of Manufacturing Sciences and Technologies and/or Data Science
• Implement process analytical technologies (PAT) frameworks.
• Responsible for the technical leadership of projects assigned according to the tasks assigned and project milestones / deliverables plan.
• Execute data acquisition, treatment and analysis using multivariate statistical analysis using standard commercial software such as R, Python, JMP, Matlab, PLS toolbox or equivalent.
• Deliver a culture of excellent customer service, with dedicated customer assistance and a mindset of co-creation.
• Identify innovation opportunities and contribute to process optimization activities, including yield improvement and cycle time reduction as well as product quality RFT.

Qualifications:

• Adaptive and creative mindset
• Solid knowledge of cGMP regulations and ICH guidelines applicable to product lifecycle management
• Experience in at least two of the following areas: process development using Quality by Design frameworks, implementation of PAT tools, process modelling, process optimization, process troubleshooting, technology transfer, scale-up and/or real-life use of advanced data science toolbox (Machine Learning, Digital Twins, etc.)
• Willingness to contribute to the vision and mission of ValGenesis Consulting
• 7-9 years of life sciences experience on a technical role (e.g. process development, technology transfer, manufacturing, manufacturing sciences and technologies, etc.) in pharma and/or biopharma
• Experience with at least one of the following programming languages/ tools: R, Python, SIMCA, Matlab, JMP, MODDE or similar
• Master’s Degree or equivalent (minimum) in Science or Engineering related fields (a PhD is valued)
• Able to work independently in a fast-paced environment
• Highly motivated professional with excellent communication and interpersonal skills

Only candidates based in Canada aligned with the requirements presented will be considered

More about us

Headquartered in South San Francisco, since 2005 we’ve grown into a global organization with offices around the world. ValGenesis is the global market leader and fastest growing provider of digital validation software for life science companies. We are proud to partner with 30 of the top 50 global pharmaceutical and biotech companies.

ValGenesis is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, age, national origin, religion, marital status, sexual orientation, ancestry, color, gender identity/expression, family/medical care leave, genetic information, medical condition, physical/mental disability, political affiliation, status as a protected veteran, status as a person with a disability, or other characteristics protected by laws or regulations.