Job description

Invivoscribe is an industry pioneer in oncology diagnostics, dedicated to improving the standard of global healthcare for over 25 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used in over 160 countries. Our global network of laboratories offer next generation molecular and flow cytometry panels to support our drug development entity and accelerate clinical trials. Our harmonized clinical laboratories offer a menu focused on clinically significant biomarkers which support therapeutic decisions, minimal residual disease (MRD) monitoring, patient stratification, trial enrollment, and the development of companion diagnostics. For 25 years, we have stood at forefront of precision diagnostics, and we’re just getting started!

We are looking to add a Manager, Product Development to our Research & Development Team. The Manager, Product Development is responsible for supervising and managing a team and projects, competently interacting with collaborators and other departments, and writing and reviewing documents in compliance with the IVS Quality Management System (QSR) and applicable regulations.

Core Responsibilities Include:

• Effectively supervises the day to day activities of assigned scientists. Provides work assignments, technical guidance, training and development. Ensures the timely completion of administrative tasks such as timekeeping, scheduling, training requirements and performance appraisals. Responsible for hiring, managing performance and corrective measures.
• Responsible for accuracy and completeness of auditable documents.
• Independently performs data analysis using available software.
• Independently designs experiments and writes protocols (per standard guidelines) and reports.
• Reviews laboratory notebooks, experimental designs, and draft protocols and reports of peers for accuracy and compliance.
• Professional interactions with collaborators as required for project success, while maintaining the confidentiality of IVS intellectual property.
• Acting as the Product Development technical lead, manage the development aspects of a project: initiation, design (feasibility, optimization, validation, and verification), writing, and execution.
• Acts as a Product Development technical resource in the assessment of new opportunities, technologies, and projects.
• Successfully interact with other departments - Manufacturing, Quality, Regulatory, and Sales and Marketing - for the development, transfer, submission, and commercialization of IVS products.
• Creates product development projects timelines and budgets.

You Bring:

• BS in Molecular Biology or scientifically related field with 8+ years of industry experience in a regulated environment to include 2+ years of supervisory experience. Advanced degree advantageous. Equivalent combination of education and experience will be considered.
• Practical knowledge with quality and regulatory requirements in the following environments: medical device, in vitro diagnostic, GLP, cGMP (QSR), IVDR or ISO.
• Proficient in Microsoft Office Suite (Word, Outlook, Excel and PowerPoint), and the ability to learn new software programs.
• Experience managing at least 3 direct reports.
• Evidence of Covid-19 vaccination

We Bring:

• A beautiful modern facility centrally located in San Diego County, with many jobs conducive to a hybrid work from home arrangement.
• A safe, fully-vaccinated, work environment.
• A diverse and inclusive work environment where you will learn, grow, and make new friends.
• A well-stocked breakroom with hot and cold beverages, snacks, refrigerator and pantry items to get you through the day.
• Competitive salaries and bonus program, incentive stock options, amazing benefit options, a 401k plan with a fully vested employer match, and generous time off benefits that include floating holidays.
• The expected pay scale is 120k to 135k annually.

Invivoscribe is an Equal Opportunity Employer.

Evidence of COVID-19 vaccination will be required as a condition of employment.

Job Type: Full-time

Pay: $120,000.00 - $135,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Experience:

• managing a project and direct supervising reports: 3 years (Required)
• Molecular Assay: 6 years (Required)
• nucleic acid extraction method development: 3 years (Required)
• product launch: 3 years (Preferred)

Work Location: One location

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