OraSure Technologies Inc. (OTI) empowers the global community to improve health and wellness by providing access to accurate, essential information. Our ability to positively affect change is powered by the innovative tools and diagnostics we deliver to the market.
Together with its wholly owned subsidiaries, OTI provides its customers with end-to-end solutions.
It’s first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and Hepatitis C (HCV) on the OraQuick® platform; sample self-collection and stabilization products for molecular applications; and oral fluid laboratory tests for detecting various drugs of abuse.
Overview
Here at the OTI our innovative sampling tools and diagnostics unlock access to accurate, essential information that advances global health and well-being. Our products include molecular sampling kits for the genome and microbiome, and rapid diagnostics for infectious disease.
Responsible for leading projects to improve quality and efficiency of manufacturing processes. Also responsible for leading the scale-up, validation, and transfer of new products into manufacturing. Responsibilities include: designing, executing, and documenting experiments, guard-band studies, generating Operations documentation for new products and validation of new processes and equipment.
Snapshot Of Responsibilities
- Investigates and implements improvements to manufacturing processes to improve quality and efficiency, ensuring that all regulatory requirements are satisfied
- Review manufacturing trending reports to ensure processes remain in control, assist manufacturing in investigating processes that yield product in specification but out of control limits
- Investigate non-conformance conditions and implement corrective actions
- Works with Product Development Teams to facilitate the successful scale-up, transfer, and validation of new products
- Prepare new and modify existing procedures as necessary for product improvements and new product transfers
- Determine Critical to Quality (CTQ) aspects of new products and ensure SPC charts are created and maintained to monitor performance of CTQ’s
- Design and execute engineering and validation studies for process improvements and new products
- Design and execute equipment qualifications for new manufacturing processes or improved manufacturing processes
- Represent Operations on multiple new product development teams.
- Ensure compliance with all pertinent safety and regulatory policies
What You Bring
- B.S. degree in Engineering (Chemical Engineering, Biomedical Engineering or Mechanical Engineering). MS preferred
- 5 or more years experience as a process improvement scientist/engineer, manufacturing manager or equivalent position in a diagnostic assay or other medical device manufacturing area.
- Experience in a variety of biochemical, immunological, microbiological, and molecular biology assay methods
- Experience in new product development and technology transfer into manufacturing
- Thorough knowledge of GMP’s
- Demonstrated technical skill and experience in process validation and equipment qualification
- Excellent analytical and problem solving skills, including previous experience with Statistical Process Control, Design of Experiments, and root cause analysis
- Good communication skills, written and oral.
- Technical writing skills including experience writing manufacturing documentation (Batch Records, Material Specs, Bills of Material, etc)
- Experience with SAP or other similar ERP system
- Good project management skills
- Previous experience leading process improvement/new product transfer projects
- Six Sigma Black Belt certification preferred
OTI encourages applications from all qualified candidates who represent the full diversity of the communities in which we operate. We apply a rigorous, consistent, and equitable standard to the assessment of all candidates, regardless of race, color, national origin, sex (including pregnancy), sexual orientation, gender identity, disability status, age, religion, veteran status or any other protected characteristic. We are committed to creating a diverse and inclusive environment where all employees are welcomed and belong.
What we have to offer:
- Tiered Medical PPO, EPO, Vision and Dental coverage
- Disability and Life Insurance Benefits
- Generous 401K plan and company-matching contributions
- Highly competitive paid time-off
- Maternity Leave and Parental Leave Coverage
- Employee Referral Program – you may be eligible for a cash bonus if your referrals are hired
- Employee Assistance Program
- Employee Service Recognition
- Job-related Training Programs
- Ability to participate in Teams, Committees, Events and Clubs
- Depending on the role you may be eligible to work in a hybrid environment or fully remotely
- Free Onsite Parking
Please note, the above applies to full-time permanent positions.
Culture, People & Community
OTI recognizes that the long-term health of our business is directly connected to the health of the planet, local communities and the OTI family of companies employees.
- LIVE IT Committee – committed to creating an environment that embodies our values
- All Means U: Employee Committee on Belonging hosts various events across all company locations such as monthly book club and mentorship program
- Wellness Committee empowers colleagues to make critical decisions to improve and protect health
- Sustainability Committee aims to minimize impact on the environment
- Social Committee who organize and run events for both remote and onsite employees, to create connection and community
At OTI, we have a clear vision; cultivate an environment of equal employment opportunity where we do not tolerate discrimination or allow the harassment of employees or applicants on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by law with regard to any employment practices.
OTI aims to create and foster workplaces that reflects and contributes to the global communities in which we do business and the customers and partners we serve. This includes all communities impacted by our corporate presence. As part of this commitment, OTI and its subsidiaries will ensure employees and applicants are provided reasonable accommodation per request. If you require disability-related accommodation during the recruitment process, please contact Rebecca Zeleney at rebecca.zeleney@dnagenotek.com. OTI will consult with all applicants who request disability-related accommodation during the recruitment process to ensure that the accommodation provided takes into account the applicant's individual accessibility needs.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
The base salary range for this full-time position is 91,000-154,000. In addition to base salary, this position is eligible for participation in our annual bonus program. The range displayed on each job posting reflects the minimum and maximum base salary for the position, based on our defined salary pay ranges. Our ranges are broad to account for differences in roles, performance, experience, skillsets, education and business needs and individual pay is determined by a variety of factors. We offer a comprehensive Total Rewards package, as noted below.
