How to Apply: Applicants may report or send resumes to Mawi DNA Technologies LLC Attn: Human Resources, 26203 Production Avenue, Ste. 3, Hayward, CA 94545. email: info@mawidna.com Please reference the position you are interested in. Mawi DNA Technologies is an Equal Opportunity Employer. We offer full benefits including vision/dental and employer matching 401K for full-time permanent employees.
Job Title: Operations Manager
Work Location: Hayward, CA.
Job Code: AB-21-1096
Job Description:
Mawi DNA Technologies is an emerging biotechnology focused on biosample collection technologies. Our iSWAB-Microbiome product is a disruptive technology being used in large quantities worldwide for COVID-19 sample collection. We are seeking an experienced Operations Manager to join our team. This is a new position and excellent ground-floor opportunity with significant room for growth and advancement.
The Operations Manager will have a proven track record of setting up and running manufacturing and supply chain operations, ISO compliance, procurement, and process automation for high volume manufacturing in a regulated environment. This position reports directly to the CEO and will play a key role in the expansion of Mawi’s business as we transition into ISO certification and FDA approval. The ideal candidate will be analytical, experienced in collecting, processing and presenting data on production levels, costs and capable of envisioning and justifying new operations. The Operations Manager will be committed to finding ways to improve operations while assuring that all quality requirements are maintained and improved, and will have hands on experience in general operations, facility management and capital projects.
To ensure success at Mawi, you should have an understanding of the FDA’s QSR, ISO 13485 and applicable ISO standards as well as a strong understanding of ERP systems, preferably the Netsuite platform.
Responsibilities:
- Manage product manufacturing, packaging, labeling, and boxing of all products.
- Manage inventory levels to assure growth targets can be met.
- Determine manufacturing equipment requirements; participate in equipment specification, acquisition and qualification.
- Assure products meet quality requirements and are manufactured per applicable standards.
- Implement and maintain ISO and /or other registrations as appropriate.
- Working with QA, RA, and production staff to implement ongoing cost savings and quality improvements. Modeling workflow, analyzing potential automation alternatives. Evaluating potential improvements to manufacturing workflow to improve output, efficiency, lower cost and improve quality.
- Setting production schedules, material and manpower resources to meet output objectives.
- Maintain a variety of reports, records and production documentation to reflect schedules, performance, methods and the like.
- Assure, together with quality and leadership teams, manufacturing compliance with GMP, ISO 13485.
- Create, execute and complete validation and qualification (IQ/OQ/PQ) documents.
- Support of the product and process development for new products, product changes and enhancements.
- Parts receiving including incoming inspection and managing the warehouse.
- Support equipment maintenance and support equipment service needs.
- Establish process controls, statistical measures of manufacturing performance and quality.
- Establish manufacturing objectives and metrics.
Requirements:
- You should have at least five years of relevant experience and training in manufacturing, and or operations with excellent communication skills and ability to build cross functional teams.
- Bachelor’s degree in business, accounting, engineering, or a related field
- Minimum of 5 years of experience in medical device or other regulated manufacturing environment.
- Previous P&L responsibility preferred
- Relevant experience scaling to high volume production of medical products
- Familiarity with FDA QSR and ISO 13485 medical device regulations.
- Ability to deliver under tight deadlines with a focus on quality.
- Led successful manufacturing operations preferably with ISO 13485 control requirements.
- Strong oral and written communication and presentation skills. Effective communicator of technical & non-technical information.
- Experience with managing processes and documents for GMP, ex: IQ/OQ/PQ.
- Authorized to work in the United States on a full-time basis, full fluency (verbal and written) of the English language is a must.
- Working knowledge of PC applications software and manufacturing systems software.
- Must have the mindset and ability to thrive in an entrepreneurial early stage company environment. Someone who is resourceful and can work independently. Can effectively make optimal use of limited resources and has an ability to work closely with others in a small team setting.
Salary: DOE
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Job Title: Quality Control Inspector
Work Location: Hayward, CA.
Job Code: AB-21-1097
Mawi DNA Technologies is an emerging biotechnology focused on biosample collection technologies. Our iSWAB-Microbiome product is a disruptive technology being used in large quantities worldwide for COVID-19 sample collection. We are seeking a detail-oriented Quality Control Inspector to join our team.
The Quality Control Inspector performs inspections, checks, tests, and samples per procedures incoming materials, parts, and components used in the manufacture of medical devices. Performs various quality assurance duties under limited supervision. Performs assessment, documentation, and organization tasks to support the efficiency and effectiveness of their organization’s supply chain. Works in accordance with Company Standard Operating Procedures (SOP).
Responsibilities:
- Perform inspections of purchased parts according to defined criteria using standard physical, mechanical, and/or electrical measurements.
- Perform and record functional testing of components; in-process and final inspection and/or assemblies and sub-assemblies.
- Understand production quality standards and determine if ongoing production meets those standards.
- Track inventory of materials and parts; issue parts to production.
- Complete confirmation of orders in SAP or other company’s systems.
- Document work on DHR/LHR. Review production lot history records and communicate problems to production and quality.
- Accurately document the results of inspections and testing.
- Initiate NCMR reports on nonconforming material and maintain NCMR log.
- Assist with maintaining the equipment’s’ calibration and preventive maintenance per the EQ requirements.
- Participate in the construction and/or revision of SOPs for the inspection function.
- Ability to perform detailed daily record keeping and reporting quality issues to management.
- Evaluate problems and make initial recommendations for possible corrective action to supervisor.
- Provide support to Manufacturing when required.
Requirements:
- High School diploma required; AA/AS degree or higher preferred.
- 2+ years’ experience in a production or manufacturing quality assurance QC or related experience in the medical device industry.
- Experience working in a Controlled Environment Room (CER).
- Proficient understanding of engineering drawings and specifications, sampling plans, and dimensional/visual inspection equipment including microscopes.
- Good math and verbal/written communications skills.
- Proficient with computer software such as Word and Excel spreadsheets preferred.
- Must be able to follow documented SOP and standards, as well as have knowledge of ISO Quality Standards (ISO 9000 or ISO 13485) and Sampling Procedures (ANSI/ASQ Z1.9 and ANSI/ASQ Z1.4).
Salary: DOE
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Job Title: Document Control Specialist II
Work Location: Hayward, CA.
Job Code: AB-21-1098
Mawi DNA Technologies is an emerging biotechnology focused on biosample collection technologies. Our iSWAB-Microbiome product is a disruptive technology being used in large quantities worldwide for COVID-19 sample collection. We are seeking a Document Control Specialist II with ISO 13485 and GMP experience to join our team.
The Document Control Specialist II will develop, coordinate, and maintain the company’s Controlled Document System and provide administrative support for the Company’s Quality System.
Responsibilities:
- Document filing, masters, copies, and drafts within a current manual and an electronic change control system.
- Evaluate Document Control Orders (DCO) for completeness and accuracy.
- Circulate and track DCO(s) out for signature, assuring timely completion.
- Maintain DCO log and Controlled Document Master list database.
- Distribution of approved documents.
- Maintain controlled document locations and retrieval of obsolete documents.
- Maintain external standards library including ordering and tracking through internet-based standards tracking service.
- Participate in the development and revision of WI, LMS, SOP, LHR, and other documentation related to document Control inspection function.
- Evaluate test data and report deviations from company’s standards operating procedures.
- Maintain supplier files and key supplier list.
- Perform data entry and material transitions in SAP/ERP/QAD system. Perform data entry for process monitoring and SPC.
- Maintain equipment files, equipment list and scheduling required equipment calibrations.
- Maintenance of Training Records.
- Maintenance of Device History Records as required.
- Review lot history records and release finished goods.
- Complete Certificates of Analysis and Conformance as required.
- Perform other duties as assigned.
Requirements:
- High School diploma required; AA/AS degree or higher preferred.
- Minimum of 2 years of document control experience in the medical device industry.
- Proficient computer skills (MS office). Good verbal and written communication skills.
- Must be detail oriented and able to work independently.
- Knowledge of ISO 13485; 2016 and GMP regulations is required.
Salary: DOE
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Job Title: R&D (Molecular Biology) Intern
Work Location: Hayward, CA.
Job Code: AB-21-1095
Job Description:
Mawi DNA Technologies is an emerging biotechnology focused on biosample collection technologies. Our iSWAB-Microbiome product is a disruptive technology currently gaining widespread use globally for COVID-19 sample collection. We are seeking a talented and highly motivated Research Intern with molecular biology background/focus to join the R&D team. The candidate will be responsible for evaluating our technology by performing various molecular assays and reagent development projects. This is a new position for a senior student and an excellent ground-floor opportunity with significant room for growth and advancement.
Our people are fundamental to our company’s success and we are devoted to their continued growth. This is a highly collaborative, communicative, and dynamic environment.
The intern working in this environment will learn:
- Basic laboratory techniques, molecular techniques, sterile technique and microbial culture.
- How to operate different types of common and more sophisticated lab equipment.
- Application of the scientific method in designing the experiment and critically evaluating the results.
- How to perform various biological assays and the analysis, interpretation, and presentation (oral, written) of the data.
Responsibilities:
- Participating in molecular assay design, testing, and improvements.
- Perform DNA and RNA extractions.
- Analyze samples using Qubit, NanoDrop and gel electrophoresis.
- Perform quantitative PCR and conventional PCR.
- Completing all assigned laboratory tasks by following and suggesting improvements to SOPs.
- Record data and results in an organized fashion.
- Prepare materials needed for experiments such as various types of media, buffers, etc.
- Performing general laboratory maintenance duties.
- Gaining knowledge of company policies, protocols, and processes.
- Complies with all company safety, training, and quality regulations (e.g. GLP/GMP requirements, etc.) and procedures.
- Other duties as assigned by supervisor.
Qualifications and Requirements:
- Student in senior standing working towards a bachelor’s degree in Biological Sciences. Preferably, an emphasis in Molecular Biology, Microbiology, Biochemistry, Biotechnology or a related field. Coursework or research experience in Molecular Biology required.
- Prior hands-on experience with common molecular biology techniques, such as pipetting, RNA/DNA extraction, quantification, PCR, and the use of analytical equipment.
- Basic understanding of data input and analysis.
- Experience with NGS library preparation is a plus.
- Experience with R (preferred) or/and Python is a plus.
- Proficient in MS Word, Excel, and PowerPoint.
- Excellent written, verbal, communication and interpersonal skills.
- Superb attention to detail and interest in scientific discovery.
- Must demonstrate excellent organizational skills, flexibility, adaptability, multi-tasking, prioritization.
- Positive attitude, resilient, high energy, passionate, competitive, and integrity required.
- Ability to work in a team environment and establish relationships with co-workers, managers, and customers.
- Ability to work at least 15 hours per week during the school year; work schedule will be determined upon hire.
Working Conditions and Physical Requirements:
- On-site work at corporate headquarters in Hayward, CA.
- Required to sit or stand for long periods. Frequently required to walk. Occasionally required to climb, stoop, or bend and lift 30+/- pounds.
The above is a list of essential duties and responsibilities for this position. This list is not all-inclusive.
Salary: $17/hr
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Job Title: Product Marketing Specialist/Manager
Work Location: Hayward, CA.
Job Code: AB-21-1093
Job Description:
Mawi DNA Technologies is an emerging biotechnology focused on biosample collection technologies. Our iSWAB-Microbiome product is a disruptive technology currently gaining widespread use globally for COVID-19 sample collection. We are seeking a Product Marketing Specialist/Manager to join our team. This is a new position and excellent ground-floor opportunity with significant room for growth and advancement.
The Product Marketing Specialist/Manager will help manage the commercial efforts of our iSWAB and HemaSure biosample collection and stabilization technologies, with an emphasis on infectious diseases and other diagnostic applications. This position will report to the VP of Sales and Marketing and will play a key role in the strategic planning and tactical execution of marketing activities. The individual will also manage day to day marketing-related tasks such as database management, promotional material, social media, and overseeing the website. This role will require interfacing with multiple stakeholders within the company including R&D, Regulatory, Sales/Business Development, and Production.
Responsibilities:
- Develop and implement product positioning and messaging based on market needs, competitive landscape, and industry and product knowledge to drive revenue and brand growth.
- Collect voice of customer information, testimonials, and perform market research.
- Works in collaboration with R&D and Regulatory to bring new products to market.
- Leads market development activities within specific application areas and customer segments to meet revenue goals.
- Partners closely with R&D and Sales/Business Development to gain an understanding of product features and relevance to market segments
- Ensure that each application area is addressed by overall marketing strategy
- Participate in product training for employees and distribution partners.
- Contribute to the development and execution of digital marketing strategies, highlighting the products at tradeshows, conferences, social media, and webinars.
- Develop content for sales material, press releases, email blasts, social media, and website. Manage and organize content library including application notes, data sheets, white papers, peer reviewed papers, posters, and abstracts.
- Work with Public Relations partners to develop and distribute press releases.
- Update and manage company CRM database daily. Ensure all customer information is current and all interaction is thoroughly captured and recorded
- Work closely with website development agency and internal stakeholders to optimize website content and search engine rankings.
- Manage development and inventory of company promotional materials.
- Participate as needed in other customer facing and revenue generating activities including sales, customer support, and order processing.
Requirements:
- Minimum B.S. degree in life sciences is a must.
- 2-5 years of experience in life sciences marketing or product management.
- Demonstrated experience with genetic testing workflows including sample collection, sample prep, and downstream applications such as PCR, NGS, and microarrays. Special consideration will be given to applicants with prior experience in infectious disease markets and exposure to regulatory requirements and processes.
- Strong written communication skills, and experience developing content for sales material, websites, and social media.
- Prior experience with CRM or ERP development preferred.
- Must have the mindset and ability to thrive in an entrepreneurial early stage company environment. Someone who is resourceful and can work independently. Can effectively make optimal use of limited resources and has an ability to work closely with others in a small team setting.
- Ability to work with the management team and other departments to meet corporate goals and initiatives while dealing within a dynamic and rapidly changing environment.
- Strong time management and organizational skills coupled with a sense of urgency and strong work ethic. Proven ability to multi-task while maintaining a high level of attention to detail.
- Must be a highly motivated self-starter but also work within corporate culture and adhere to codes of conduct.
- Prior customer-facing experience desired.
- 10-20% travel may be required, but only after conditions are absolutely safe to do so.
Salary: DOE
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Job Title: Administrative Assistant/Receptionist
Work Location: Hayward, CA.
Job Code: AB-21-1094
Job Description:
Mawi DNA Technologies is an emerging biotechnology company focused on biosample collection technologies. Our iSWAB-Microbiome product is a disruptive technology currently being used globally for COVID-19 sample collection. We are currently seeking an organized, detail-oriented, and responsible Administrative Assistant/Receptionist to join our team. This role requires someone who is patient, has a positive attitude, and can thrive in a fast-paced, small company environment. Qualified candidates will have experience in office support and taking on a variety of administrative responsibilities. This is a fantastic opportunity to make an impact and be an integral part of an emerging, rapidly growing biotech company. This position will start as temp-to-hire and transition to full-time permanent for the right candidate.
Responsibilities:
- Manage office environment to ensure it meets the needs of staff and visitors.
- May support senior staff members with various administrative activities, including meeting and conference scheduling, travel arrangements, expense submissions, and general calendar management.
- Proactively manage facilities, including kitchen, office supplies, decor and shipping/receiving.
- Identify and manage external office vendors and service providers.
- Answer the company’s main phone line for outside callers; transferring calls and taking and ensuring messages are passed to the appropriate employee on a timely basis.
- Handle sensitive and confidential information with discretion.
- Assist with special projects in various functional areas and departments as needed.
- Assist with HR-related tasks such as employee recruitment, onboarding, retention, and benefits administration to foster employee satisfaction and productivity.
- Maintain employee snack supplies for the break room; manage order and delivery process and check in regularly to assure snacks are available for employees.
- Sort and distribute mail and packages as needed.
- Greet and provide guidance to visitors and vendors to sign the visitor entry sheet in accordance with company safety protocols.
Preferred Qualifications and Desired Traits/Skills:
- High school diploma; Associate’s or Bachelor’s degree preferred.
- Minimum 2-4 years or equivalent work-related experience.
- Experience in a multi-faceted support role in a fast-paced environment.
- Highly proficient MS Office Suite.
- Handling facilities including furnishing offices and managing light construction projects a plus.
- Prior experience in start-up companies of medical technology, biotech or diagnostics company a plus.
- Must have the mindset and ability to thrive in an entrepreneurial early stage company environment. Someone who is resourceful and can work independently. Can effectively make optimal use of limited resources and has an ability to work closely with others in a team setting.
- Strong time management and organizational skills coupled with a sense of urgency and strong work ethic. Proven ability to multi-task while maintaining a high level of attention to detail in written or verbal communication.
- A professional presence and strong interpersonal skills for interacting in a courteous, timely, and diplomatic manner with all levels of employees as well as other parties/stakeholders involved with the organization. Can defuse emotional situations calmly and professionally.
- Organizational, project, and priority management skills for planning, executing and following up on issues, projects and daily responsibilities in order to meet established deadlines.
Salary: $18 – $25/hr. Starting at temp-to-hire transitioning to FT permanent for the right candidate