Job Description

• Investigate and solve manufacturing issues related to biological detection products as they occur; implement corrective and preventative actions.
• Champion LEAN culture and continuous improvement initiatives. Supports CI events to ensure that improvements are captured, implemented and sustained.
• Create and maintain manufacturing job test procedures, work instructions, and master process documents.
• Design manufacturing fixtures and prototypes as required.
• Develop process and test protocols for automated equipment and manual processes.
• Establish and maintain routings, control BOM changes, and maintain BOM configuration dates.
• Maintain master material data for all manufactured products.
• Drive cost reduction projects to meet requirements of Value Engineering initiatives.
• Perform validation testing on new products and changes to existing products.
• Primary liaison with Development and Engineering teams on new products and engineering issues.
• Responsible for seeing that engineering changes are validated and implemented in manufacturing.
• Lead continuous improvement of cell culture-based production of biosensors for uniform performance and cost reductions
• Develop and implement quality standards and perform QC tests for biosensors and other reagents
• Develop and conduct reagent stability studies and validations
• Lead material requirements planning and inventory management for all biosensor-related parts.
• Drive cell banking production process for all current and new biosensor cell lines.
• Maintain all site equipment certifications and preventative maintenances
• Develop, improve, and implement cGMP practices in biotechnology lab settings
• Complies with and ensures department compliance with all Company, policies and procedures.

Qualifications

Education/training:

• Bachelors degree in biology, biomedical engineering, or other related field
• Will consider applicants with equivalent work experience

Experience:

• 2-5 years related experience in a discreet manufacturing environment – ideally with extensive hands-on experience in cell culture including working with adherent and non-adherent mammalian cell lines, preparing master and working banks, and with cryopreservation techniques. A working knowledge of non-adherent mammalian cell culture and expressing proteins in mammalian cell lines is a plus.
• Experience in technical writing, writing quality procedures, process procedures, or assembly instructions.

Knowledge/skills:

• Advanced computer skills including Excel, Microsoft Word and Outlook; SAP or equivalent is preferred; CAD-based systems and bioinformatics is a plus.
• Hands-on experience with ISO 9001 and Lean Manufacturing.
• Hands on knowledge in additional ISO quality systems and cGMP manufacturing is a plus.
• Working knowledge of cell biology, molecular biology and immunology.
• Working knowledge of basic microbiology techniques and ability to work with BSL-2 level pathogens.
• Ability to design experiments, interpret data, and prepare final reports.
• Ability to troubleshoot protocols and procedures.
• Team player and possesses a strong capability to work independently.
• Strong verbal and written communication skills.
• Ability to gain the trust and respect of your team members.
• Good organizational skills and attention to detail.

Background:

This position may require Sensitive Security Information (SSI) access and vetting via the TSA. If required, applicant must successfully pass a federal background investigation.
This position may require a U.S. Personal Security Clearance.

SDI is a Federal Contractor and a drug-free workplace. By submitting an application, I confirm that I understand that the Company has a right to require me to submit to a drug test prior to employment and at any time during my employment, to the extent permitted by law.

WORK ENVIRONMENT: The individual’s primary workplace is located in the Baltimore, MD biotechnology manufacturing facility; there are no exposures to unusual elements; possible exposure to biohazardous agents in BSL-2 laboratory

Additional Information

We offer…

Join us and we’ll help build your career, with excellent training and opportunities for career growth across the business, both locally and globally. You’ll experience an inclusive environment, with strong leadership and a focus on safety and wellbeing. You’ll also have the flexibility to choose from a wide range of benefits to suit your lifestyle, offering you and your family support from a health and wellbeing, financial and lifestyle perspective.

Join us and work for a world-leader, with the benefits and training to reward your dedication and skills. Be part of a team where we are making the world a safer place.

Smiths Detection is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. _Equal Employment Opportunity Posters _If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email hr-1@smiths-detection.com.

The compensation for this position ranges from $69,216 - 103,824/ yr and will vary depending on factors such as your location, skills, job-related knowledge, and experience. The compensation package may also include incentive compensation opportunities in the form of discretionary annual bonus or commissions. Smiths Detection provides comprehensive benefits including healthcare, 401K savings plan, company holidays, vacation, sick time, parental leave and an employee assistance program. Eligibility requirements apply.

If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail stat@smiths.com or call toll-free 877-703-1029. This email and phone number is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response. Smiths Detection, Inc. participates in the Electronic Employment Verification Program.

We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of race, colour, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity.

At no time during the hiring process will Smiths Group, nor any of our recruitment partners ever request payment to enable participation – including, but not limited to, interviews or testing. Avoid fraudulent requests by applying jobs directly through our career’s website (Careers - Smiths Group plc)