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Head of Regulatory Affairs and Quality Assurance

Position Overview:
The employee works with the management team to
• Oversee quality and legislative requirements of all products and services
• Work with contractors and regulatory agencies for product approval and life cycle management
• Manage regulatory and technical team
 
Required Education, Skills and Experience:
• Minimum of a bachelor’s degree in a life scientific field such as Biochemistry, Biotechnology, Pharmacy, Medicinal chemistry, or Biomedical science
• Minimum of 5 years of experience in a similar role
• Excellent verbal and written communication skills
• Strong problem-solving skills
• Highly developed attention to detail
• Strong project management skills
• Proficiency in Chinese
 
Essential Functions/Responsibilities
Regulatory Affairs:
• Ensuring products in compliance with 510K regulations set by the Regulatory Agency
• Composing product, scientific and legal documents
• Working with others in the company on various products for technical and regulatory related matters
• Planning, undertaking and overseeing 510K clinical trials and FDA regulatory inspections
• Keeping up to date with changes in regulatory legislation and guidelines
• Obtaining marketing permission
• Liaising and negotiating with regulatory authorities
• Providing advice about regulations to manufacturers/scientists
• Ensuring that quality standards are met, and submissions meet strict deadlines


Send your resume to [email protected]

Head of Business Development

Position Summary
Genabio is a global leader in the production of over-the-counter self-testing products, with an impressive sales record of over $100 million in the past three years. Our extensive customer base spans across the USA, Canada, the UK, Japan, and India. Our products are being sold in leading pharmacies such as Walgreen, Wegmans, Giant Eagle, H.E.B., and Safeway.
The ideal candidate will lead initiatives to generate and engage with business partners to build new business for the company. This candidate will be focused and have strong communication skills. They should be able to think critically when making plans and have a demonstrated ability to execute a particular strategy.

Responsibilities
• Maintain relationships with businesses and communicate internally for orders, payments, logistics, and customer services
• Explore business opportunities with leading retail pharmacies, government, and distributors
• Communicate with sourcing and technical team to identify new products or opportunities
• Collaborate with China and US team on product development, sourcing, design, production, and logistics
• Additional tasks as directed by the CEO

Qualifications
• Bachelor's degree or equivalent experience
• 8 or more years' prior industry related sales experience in to-B sales
• Strong communication and interpersonal skills
• Proven knowledge and execution of successful development strategies
• Be able to travel nationally and internationally
• Chinese is a plus


Send your resume to [email protected]

Research Associate

The candidate will participate in product development activities for targeting 510K submission.  Major responsibility includes but not limit to conducting feasibility test, optimization of assays, troubleshooting of methods, support process development and transfer to manufacturing partners (including CROs or CMOs).  Experience with designing and performing laboratory experiments, data analysis, and operating in a ISO13485 or CFR820 regulated environment is highly preferred.  
 
Essential Responsibilities and Accountabilities:  
· Designs and executes of laboratory experiments and analysis of data
· Troubleshoot and improve existing chemistries, processes, and methods 
· Responsible for compliance with the company’s quality system requirements through training and adherence to policies, procedures, and processes 
· Participate in product improvement and support manufacturing, as required 
· Conduct literature reviews; summarize and evaluate obtained information 
· Aid in identifying root cause of production/manufacturing failures using structured problem solving and applies fixes to prevent reoccurrence 
· Conduct product quality control inspection test and other bench test with little supervision in a ISO13485 or CFR820 regulated environment 
· Prepare other study reports, procedures, and presentations 
· Maintains and promotes good housekeeping (order & cleanliness) and safe behavior in labs 
· Work with BSL-2 level pathogens may be required

Qualifications: 
· Bachelor/Master degree in chemistry, biochemistry, biology, biomedical science or related field, with 2-5 years industrial experiences
· Experience working in a ISO13485 or CFR 820 regulated environment preferred 
· Working knowledge of lateral flow immunoassay, ELISA, or immunoassay-based systems and analogous diagnostic devices
· Hands-on experience in general bioassay development including antibody screening, bioconjugation, process development, assay performance optimization, and troubleshooting are strongly preferred
· Experience with immunoassay application to variable biomarkers is preferred. 
· Computer literacy, including practical knowledge of Microsoft Office 365 and programs suitable for assay development
· Good organizational skills 
· Contribute to experimental design, data analysis, critical thinking, and problem-solving to improve methods and procedures.
· Contribute to a culture that values diversity and promotes respect, inclusion, cooperation, and responsibility
· Demonstrate good interpersonal skills and work well with personnel at all levels.
· Highly organized and the ability to multitask
 
Education and Experience:
· MS in Biology, Biochemistry, Bioengineering or related field with 0-1 years of related experience, or BS with 2-5 years of industry experience.


Send your resume to [email protected]

Product Manager OTC

Product Development:
· Collaborate with cross-functional teams to develop new OTC products from conception to launch.
· Conduct market research to identify gaps and opportunities within the OTC market.
· Manage the product development lifecycle, ensuring products meet regulatory requirements and consumer needs.

Product Strategy and Roadmap:
· Define the product vision and strategy for the OTC product line, aligning with company objectives.
· Develop a comprehensive product roadmap to guide product development and launches.
· Conduct competitive analysis and market research to make informed strategic product decisions.

Cross-functional Collaboration:
· Work closely with marketing, sales, and R&D teams to execute product launches and marketing campaigns.
· Collaborate with regulatory affairs to ensure products comply with all relevant regulations and standards.
· Coordinate with supply chain and operations to ensure timely product availability.

Customer Focus:
· Conduct consumer research to understand preferences, needs, and feedback related to OTC products.
· Develop and maintain a deep understanding of consumer segments to tailor products and marketing strategies accordingly.
· Engage with customers to gather feedback and insights to improve existing products and inform future development.

Product Performance and Analysis:
· Monitor product performance using appropriate metrics and KPIs.
· Analyze sales data, customer feedback, and market trends to identify opportunities for product enhancement or new product development.
· Implement strategies to drive product adoption, usage, and customer satisfaction.

Marketing and Promotion:
· Develop marketing plans and campaigns to promote OTC products effectively.
· Collaborate with the marketing team to create compelling product messaging and positioning strategies.
· Monitor marketing initiatives and optimize strategies based on performance analysis.

Qualifications:
· Bachelor's degree in Marketing, Business Administration, or a related field (Master's preferred).
· Proven experience as a Product Manager, preferably with a focus on OTC products.
· Strong understanding of OTC regulations and compliance requirements.
· Exceptional project management skills with the ability to manage multiple projects simultaneously.
· Excellent communication, analytical, and problem-solving skills.
· Results-oriented mindset with a focus on achieving targets and driving business growth.
· Team player with the ability to collaborate effectively with cross-functional teams.


Send your resume to [email protected]

Sales Specialist(Base: Boston)

The ideal candidate will lead initiatives to generate and engage with business partners to build new business for the company. This candidate will be focused and have strong communication skills. They should be able to think critically when making plans and have a demonstrated ability to execute a particular strategy.

Send your resume to [email protected]

Diagnostic Sales Representative/Manager

With deep expertise in diagnostics, GenaBio Diagnostics is creating solutions to address the needs of COVID, toxicology and other infectious diseases. Genabio is an exciting early-stage company and brings together experienced scientists and industry veterans with a proven track record in diagnostic product development, marketing, and sales. Since 2020, we are working with leading partners in the United States including Quest Diagnostics, UCSF, Boston University, UNC Rex Medical Center, and many more labs on COVID-19 tests.

Summary
Genabio Diagnostics is looking for a sales representative who is looking to add value to our growing organization. The individual should be highly motivated with a strong work ethic, outgoing personality and a understanding of biological laboratories. This position will be the first sales role for the company and the individual will contribute to many companies work streams including inside sales, logistics, and marketing.

Responsibilities：
1. Responsible for achieving product sales to new and established accounts to accomplish sales objectives and greater market penetration.
2. Creates a plan to achieve objectives through sales and servicing of customers in a prescribed territory. Schedules appointments and makes sales presentations to customers.
3. Makes regular visits to customer locations to gather information on orders and market conditions.
4. Develops customer and product focused presentation packages for sales.
5. Prepares sales reports and documents as required.
6. Follows up with customers to resolve any issues and ensure satisfaction.
7. Develops and maintains sales forecast and submits to management. Relays relevant market information to management.

Qualifications：
1. Bachelor’s degree or above, preferred majoring in biomedical science
2. Chinese speaker is a plus
3. Good communication skills
4. Highly motivated and able to work independently
5. Professional demeanor along with excellent communication, presentation, negotiation, follow up and sales closing skills.
6. Willing to travel within USA


Send your resume to [email protected]

Diagnostic Sales Representative/Manager

With deep expertise in diagnostics, GenaBio Diagnostics is creating solutions to address the needs of COVID, toxicology and other infectious diseases. Genabio is an exciting early stage company and brings together experienced scientists and industry veterans with a proven track record in diagnostic product development, marketing, and sales. Since 2020, we are working with leading partners in the United States including Quest Diagnostics, UCSF, Boston University, UNC Rex Medical Center, and many more labs on COVID-19 tests. 
Summary
Genabio Diagnostics is looking for a sales representative who is looking to add value to our growing organization. The individual should be highly motivated with a strong work ethic, outgoing personality and a understanding of biological laboratories. This position will be the first sales role for the company and the individual will contribute to many company workstreams including inside sales, logistics, and marketing.
Responsibilities：
1. Responsible for achieving product sales to new and established accounts to accomplish sales objectives and greater market penetration.
2. Creates a plan to achieve objectives through sales and servicing of customers in a prescribed territory. Schedules appointments and makes preplanned sales presentations to customers.
3. Makes regular visits to customer locations to gather information on orders and market conditions.
4. Develops customer and product focused presentation packages for sales.
5. Prepares sales reports and documents as required.
6. Follows up with customers to resolve any issues and ensure satisfaction.
7. Develops and maintains sales forecast and submits to management. Relays relevant market information to management.
Qualifications：
1. Bachelor Degree, preferred majoring in biomedical science
2. Chinese speaker is a plus
3. Good communication skills
4. Highly motivated and able to work independently
5. Professional demeanor along with excellent communication, presentation, negotiation, follow up and closing skills.
6. Willing to travel within USA
 


Send your resume to [email protected]

US Account Manager

Responsibilities:
1. Responsible for the sales work in the U.S. region, selling the company's testing products (Covid, drug of abuse test and other) and related consumables, developing direct customer and dealer channels;
2. Actively contact and visit customers as needed, maintain customers daily, independently take charge of business negotiation, signing contracts, and order processing, implementation and implementation;
3. Participate in after-sales service. Participate in the coordination of customer return and exchange; Participate in quality problem analysis;
4. Responsible for the tracking and analysis of product sales, market and competitor information understanding and feedback.
 
Requirements:
1. Bachelor degree or above, living in Boston
2. International trade, biomedical and other related majors, 2 years of medical equipment or diagnostic reagent sales experience preferred;
3. English listening, speaking, reading and writing can reach the native language level, can communicate with unimpeded interviews and correspondence, and can accurately grasp the customer needs and market status;
4. Be proficient in using office and other daily office application software; Self discipline, high efficiency execution, strong compressive ability, good professional and personal quality, and a high sense of responsibility and teamwork.

Send your resume to [email protected]