Lateral Flow Strip Manufacturing Operator

Sherlock Biosciences based out of Cambridge and Oxford, UK, is a wholly owned subsidiary of OraSure Technologies Inc. (OTI), and enables the democratization and decentralization of testing to personalize healthcare and make an impact on global health. 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.

Overview 

Here at 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.

Snapshot of Responsibilities:

• Provide technical support for LFS manufacturing process development and characterization. 
• Working cross-functionally, identify failure modes throughout the LFS manufacturing process, characterize them, and develop mitigation strategies. 
• Collaborate with cross-functional teams to develop and implement process improvements, ensuring optimized and efficient manufacturing operations. 
• Conduct cross-functional process investigations and root cause analyses to identify and address deviations, non-conformances, and other process-related issues. implementing corrective and preventive actions as necessary. 
• Fabrication of lateral flow strips per established procedures for use in devices and bench work for various studies. Maintain proper batch records and associated records as required. 
• Documentation and Communication: Organize data, analyze results, and communicate findings to cross-functional teams. Author technical documents such as protocols and test reports. 
• Development of work instructions and standard operating procedures in partnership with members of the R&D team and broader Operations organization. 
• Perform other duties as assigned. 

What You Bring:

• Minimum of 2+ years of experience in manufacturing operations or development transfer activities in the pharmaceutical, diagnostic, IVD, medical, or similarly regulated industry 
• Experience with lateral flow strip manufacturing equipment (e.g. Biodot) preferred. 
• Proficient in data analysis and statistical tools for process monitoring and optimization. 
• Excellent problem-solving and troubleshooting skills: experience using structured, formal root cause analyses to resolve problems in a team environment. 
• Strong communication and collaboration skills, with the ability to work effectively in a cross-functional team environment. 
• Detail-oriented, with a commitment to ensuring compliance and delivering high-quality results. 
• Experience working in a 6S environment preferred. 
• Medical device or other regulated industry experience preferred. 
• Start-up environment experience preferred. 
• This is an onsite role. 

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: 

- Private Insurance – which includes supplemental health coverage and dental coverage

- Life Insurance Benefits

- Pension scheme

- 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 OTI 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 [email protected]. 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.