What are the responsibilities and job description for the Manager, Reagent Process Development position at BioNano Genomics?
At Bionano Genomics®, we are committed to unlocking understanding of genome biology to advance the promise of genomics in areas including cancer and human disease, agricultural bioengineering and genome discovery. Our optical genome mapping and analysis tools help researchers see true genome structure to fill in what’s missing from sequencing-based data.
At Bionano, we are invested in the success of our customers and users around the world, and are dedicated to supporting them with the tools, resources and support they need to achieve their goals and make a real impact on improving quality of life for all.
Bionano Genomics is seeking a driven Manager, Reagent Process Development to own the New Product Introduction (NPI) process for Bionano’s reagent and consumable products. In this position, the person will lead a growing NPI team and work closely with development and manufacturing in generating production specifications, characterizing the product including shelf-life and shipping conditions, developing manufacturing and QC processes, identifying, and deploying analytical tests, transferring the processes to Manufacturing and assessing the technical capabilities of key suppliers.
The candidate should have strong hands-on laboratory experience, including reagent formulations, sample preparation, analytical assay development and preferably genomics assays development experience
Primary Duties and Responsibilities
- Own the New Product Introduction (NPI) process for reagents and consumables
- Lead the NPI team
- Oversee hands-on testing of assay workflows on the Saphyr platform.
- Plan, conduct, analyze, interpret, and report recommendations based on tested experimental results.
- Support product commercialization from design transfer to manufacturing.
- Assess information to ensure data sufficiency and completeness of results.
- Help write batch records, experimental protocols, summaries, and reports.
- Source and qualify external vendors, develop specifications, set up supply and manufacturing process.
- Work as part of a scientific team and participate in team meetings and initiatives.
- Work in ISO 9001 and 13485 regulated environments.
Required Skills/Abilities
- Prior experience in NPI activities
- Prior functional or team leadership experience
- Deep understanding of biochemistry, molecular biology, development of analytical and functional assays, DOE, statistical data analysis.
- Hands-on scientist with experience in QC assay development and validation.
- Skilled at writing batch records, validation reports, with experience in quality management system, risk analysis and mitigation
- Ability to take initiative and independently drive projects to completion with detailed and efficient execution and reporting.
Preferred Skills/Abilities
- Knowledge of Saphyr Optical Genome Mapping System is a plus
Education and Experience Requirements
- PhD/Masters in Biochemistry or Molecular Biology with 4/6 plus years of direct experience transitioning products from Development to Manufacturing, preferably in the Genomics industry
Bionano Genomics does not accept resumes submitted by agencies. The Human Resources team is the focal point for all recruitment and hiring at the company. Agencies are asked not to contact or forward resumes to our Executive team, Management team, or any current Bionano employee for consideration. Resumes are only accepted from agencies if a signed agreement is in place and therefore Bionano Genomics is not responsible for any fees related to unsolicited resumes.
Bionano Genomics is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of any kind. Bionano is committed to the principles of equal opportunity employment for all employees and to providing a work environment free of discrimination and harassment. All employment decisions at Bionano are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Bionano will not tolerate discrimination or harassment based on any of these characteristics and encourages applicants of all ages. Bionano participates in E-Verify.