Senior Biochemist

at Siemens in Newark, Delaware, United States

Job Description

Now’sour time to inspire the future of healthcare together.

Siemens Healthineers is a leading
global medical technology company with over 170 years of experience
and 18,000 patents. More than 48,000 dedicated colleagues in over 70
countries are driven to shape the future of healthcare. We stand with our
customers around the world to support them in delivering high quality care to
their patients. An estimated 5 million patients across the globe benefit
every day from our innovative technologies and services in the areas of
diagnostic and therapeutic imaging, laboratory diagnostics and molecular
medicine, as well as digital health and enterprise services. This is what truly
matters to us.

our team now at Siemens Healthineers as a Technical Project Manager

This is a role well suited to an ambitious professional, lookingfor the next step in their career. As a Technical Project Manager, you will beresponsible for :

· Development,
planning, execution, and functionally direction of project(s) with complex
features. Oversee all aspects of project work related to
Manufacturing and Supply Chain on clinical chemistry assay product development
teams to ensure that Manufacturing deliverables are completed in a quality
compliant manner on schedule and that the test, release and manufacturing
control systems for those products are established using the best manufacturing
standards to ensure only the highest quality products are released to our

· Coordinating/leading
a network of personnel assigned to achieve project objectives.

· Leading
commercial manufacturing support projects to address process or supply chain
issues that impact production or quality. This will entail
conducting troubleshooting activities as necessary to determine the root cause
for failures and identify, implement and verify corrective
actions. Should be able to plan and execute assay design verification
and process validation studies.

This position may suit you best if you are familiarwith what is below, and would like to do develop your career with Healthineers

+ Complexproject team management experience including managing projects forFDA-regulated clinical diagnostic or pharmaceutical products.

+ Leadinglarge and diverse teams that span multiple organizations. and influencingproduct design teams to develop products aligned with requirements forlow-cost, low-overhead, high quality, sustainablemanufacturing.

+ Analysisof statistical product performance data to establish and determinesufficiency of process control parameters. This includes theassessment of such parameters to determine the robustness of the productdesign to consistently meet all performance specifications during manufacture.

+ Designing,developing and commissioning new biochemical manufacturing processes andfunctional test methods as well as working in a FDA regulated environmentand the use cGMP practices.

+ Developmentof operational and test procedures, development of statistical processcontrol and reporting schemes, process and product validations, projectfinancing and cost estimation are highly desired.

+ LeanManufacturing & Quality Control principles.

Requiredskills to have for the success of this role

+ Aminimum of 5 years of experience in the production of biochemically-basedmedical devices and/or the development of statistical process controls forbiochemically-based medical products. Demonstrated evidence that they cannot only lead Manufacturing/Quality Control teams whose deliverables theyare directly responsible for but also drive and influence product designteams to develop products aligned with requirements for low-cost,low-overhead, high quality, sustainablemanufacturing. Candidate should be fluent with MicrosoftProject, experienced in development of resource/headcount plans,operational, statistics, excel macro & workbook development,

+ Minimumof 5 years of experience in designing, developing and commissioning newbiochemical manufacturing processes working in a FDA regulated environmentand be specifically familiar with cGMP requirements.

+ Degreesin Biochemical Engineering, Chemical Engineering, Biochemistry orChemistry preferred, however, other disciplines may be considered forcandidates with greater than 5 years of project management experience inclinical diagnostics or pharmaceutical productmanufacturing. Candidate must be familiar with safety aspectsof bio-hazardous materials and provide technical support for regulatorysubmissions/registrations and be experienced in risk management practicesincluding pFMEA and FTA’s.

+ Abilityto motivate and build strong working relationships in cross-functionalproject teams to develop technical solutions is amust. Additionally, the successful candidate will be expectedto help identify, codify and train others on best new product introductionpractices.

Siemens Healthineers hasrecently announced the next steps in our continued commitment to prioritizecolleague health, comply with customer/business partner requirements, and helppreserve our business continuity. Going forward, please be aware thatSiemens Healthineers requires full vaccination for COVID-19 for our U.S.employees, contractors, and business partners, where local conditions allow,who:

1) Are customer-facing(e.g., those required to visit a customer/business partner site or interactin-person with customers at any conference or meeting) OR

2) Come on-site, whetherregularly or occasionally, at any Siemens Healthineers location.

(Note: Accommodations may berequested for certain medical or religious reasons)

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.

Ifyou want to join us in transforming the way healthcare is delivered, visit ourcareer site at .

you wish to find out more about the specific before applying, please
visit: .

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


Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Mid-level Professional

Job Type: Full-time

Equal Employment Opportunity Statement

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.

EEO is the Law

Applicants and employees are protected under Federal law from discrimination. To learn more, Click here ( .

Pay Transparency Non-Discrimination Provision

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To

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Job Posting: JC191826245

Posted On: Sep 06, 2021

Updated On: Oct 24, 2021