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Chromatography Laboratory Supervisor

Job Description

Siemens Healthineers offers generous sign-on bonuses up to $5,000*

Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare.  For everyone. Everywhere.

 

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as Chromatography Manufacturing Senior Supervisor.

The Chromatography Manufacturing Senior Supervisor (Antibody Purification, Biotinylated Conjugates, and Lite Reagent Concentrates) position plays a key role for the Chromatography Manufacturing team at the Siemens East Walpole facility.  This area is critical for delivering quality components to be used in the Atellica and Centaur Systems portfolio of cardiac, oncology, infectious disease, and thyroid assays.

Reporting to the Senior Manager of Manufacturing, the primary functions of this individual are to supervise Chromatography Manufacturing Technicians and Biochemists (a team of 14 direct reports), maintain cGMP compliance and adherence to site SOP’s, provide technical guidance to Manufacturing Technicians, and to represent Chromatography Manufacturing as a Subject Matter Expert (SME) in cross-functional team meetings.

The scope of this role includes the manufacture of production batches for the Concentrates and Purification work centers.  Additionally, the scope of this role includes supporting projects (e.g., scale-ups, change projects, validations) within the business as well as owning and completing key deliverables at Siemens Healthineers.

Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

 

Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world.  We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Chromatography Manufacturing Senior Supervisor, will be responsible for:

•           Supervising Chromatography Operators, Technicians, and Biochemists. 

•           Purification, conjugation, and labeling of antibodies/antigens

•           Maintaining cGMP compliance and adherences to site SOP’s

•           Providing technical guidance to Manufacturing Operators, Technicians, and Biochemists

•           Driving improvements in manufacturing processes

•           Developing employees

•           Auditing manufacturing documentation including Manufacturing Batch Records, Bills of Materials, Routings, Process Documents, and SOP’s

•           Working with Chromatography Biochemists to coordinate and monitor day to day assignments of the Chromatography group

•           Working with the Trainers and Chromatography Biochemists to provide training to qualify members of the team for manufacturing activities

•           Reviewing and approving Timecards and PTO requests and ensures adequate staffing to meet scheduled demands.

•           Representing Chromatography Manufacturing in cross functional meetings including, design element teams, planning and scheduling, and product troubleshooting projects. 

•           Authoring, Reviewing, and Approving Quality System documentation including but not limited to Quality Notifications (QN’s), Temporary Manufacturing Deviations (TMDs). Corrective and Preventive Actions (CAPA’s) and Change Impact Assessment (CIA’s)

•           Back-filling on the manufacturing floor to meet work center demands

•           Fostering a diverse and inclusive environment as part of world class team

This position includes the handling of all types of materials, including biohazardous, hazardous, and DEA (Drug Enforcement Agency) controlled materials.

Required Knowledge/Skills, Education, and Experience

•           Bachelor’s Degree in Life Science discipline. (Biology, Chemistry, Engineering, or other applicable Science Degree)

•           3-5 years chromatography work experience. 

•           5-7 years’ experience working in a similar role in the medical diagnostic/ medical device industry

•           Solid understanding of the use of laboratory equipment used in manufacturing and witnessing manufacturing batch records.

•           Experience doing troubleshooting and investigation work, as well as associated outcomes.

•           Effective communication skills, both verbal and in written form. The ability to communicate is critical to the successful delivery of information to customers and the team, with regards to priorities and expectations. 

•           Experience working with automated manufacturing equipment. 

•           Solid understanding of the use of laboratory equipment used in chromatography and witnessing manufacturing batch records. 

•           Excellent time management skills 

•           Ability to meet multiple commitments, for both the daily manufacturing deliverables, as well as the mid to long term projects. 

•           Strong understanding of cGMP manufacturing in a controlled environment, as well as an understanding of ISO requirements. 

•           Ability to present information in technical or scientific writing format.

•           Experience in presenting data in table and graphic charts in Excel.

•           Skilled in Microsoft Office Programs

•           Ability to provide guidance and leadership

•           Must pass a Drug Enforcement Agency (DEA) background check.

Preferred Knowledge/Skills, Education, and Experience

•           Experience with AKTAs

•           A solid technical background in manufacturing processes

•           A background with program development/modification

•           Prior experience manufacturing commercialized automated immunoassays and/or ELISA and chemiluminescent products

•           Working knowledge of Lean and other Continuous Improvement philosophies and techniques

•           Proficiency with Microsoft Office applications

•           Experience with Mini-tab or other statistical tools

•           Prior knowledge and use of SAP or similar MRP/ERP system

Qualified Applicants must be legally authorized for employment in the United States. Qualified Applicants will not require employer sponsored work authorization now or in the future for employment in the United States.

Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity.  Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date, except where prohibited by state law.  Accommodations may be requested for certain medical or religious reasons.  If you choose to submit an accommodation request it should be submitted within 3 business days of receiving a verbal offer.  Details on how to submit approval will be provided by your recruiter.  An accommodation approval must be confirmed prior to your start date.  A start date cannot be confirmed until the accommodation has been reviewed.  An accommodation is based on your role.  If you are a currently a Siemens Healthineers employee with an existing approved accommodation, it will need to be re-evaluated prior to starting a new role.

Why you’ll love working for Siemens Healthineers

  • Be part of exciting and innovative projects that help solve some of the world’s most significant health problems.
  • Engaging, challenging, and fast evolving, cutting edge technological environment.
  • Opportunities to advance your career.
  • Competitive total rewards package.
  • Contribute to our social responsibility initiatives focused on access to education and technology, and sustainability, making a positive impact on communities.
  • Participate in our celebrations and social events.
  • Opportunities to contribute your innovative ideas and get paid for them!
  • Employee perks and discounts.

We are globally recognized as an Employer of Choice, but don’t just take our word for it. Here are some of our most recent awards and recognition:

  • Great Place to Work Certified 2021
  • Best Places to Work for LGBTQ Equality
  • Best for Vets Employers by Military Times
  • Glassdoor Employer Rating: 4.0

Review our Benefits Summary:

Explore the Siemens Benefits QuickStart https://benefitsatshs.com/  website to learn about our competitive Benefits plans which we proudly offer to our regular full-time employees. The QuickStart website can be accessed by clicking the link above or by copying and pasting it into your web browser’s address bar and selecting “Thinking of Joining Siemens” to the left of the page.

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose:  To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

Beware of Job Scams

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site.  

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.

*Sign-on bonuses range from $1,500 to $5,000 and are determined by individual position level, division, and location.  Sign-on bonus offer is exclusive to external candidates who receive and accept an offer of employment with Siemens Healthineers.



Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Mid-level Professional

Job Type: Full-time



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Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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