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Merck Specialist - Bio Technology Solutions in Elkhorn, Nebraska

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

The function of Scientists at Bio Technology and Solutions (BTS) - Tech Hub will have a focus in Vaccine and Biologicals processes development for Manufacturing. BTS Tech Hub is responsible for process development of production processes.

Within a multidisciplinary environment you will cooperate with your colleagues at BTS, Manufacturing, Engineering, Quality and R&D. Your main field of attention is to provide all round technological support on Vaccine and Biologicals Manufacturing of new (R&D) products.

Responsibilities :

  • Works independently as a team member on the development and scale up of processes or technologies of microbial, virus and cell cultivations, biomolecules concentration and purification and final formulation of veterinary vaccines and therapeutics.

  • Works independently as a team member on the transfer of processes or technologies of microbial, virus and cell cultivations, biomolecules concentration and purification and final formulation of veterinary vaccines and therapeutics to the production lines.

  • Works independently as a team member on the development of processes or technologies and its transfer to the production lines within the timelines set for this purpose, whereby these processes and technologies meet the requirements of the customer with regard to safety, quality, cost-efficiency, practical applicability and consistency.

  • Works independently as a team member on technical investigations, validation and/or process improvement projects.

  • Examines issues from diverse perspectives (safety, compliance, automation, equipment, process and people) in order to best understand and resolve the root cause.

  • Whether or not in collaboration with team members from other departments (e.g. QC, Pharmaceutical Technical Support, R&D, Production or Analytical Technical Services) gives direction to scientifically based decisions within projects aimed at the improvement of products, solving problems or development of new products.

  • If necessary, performs development, introduction and/or testing of new technologies.

  • Collaborates and interfaces with R&D and Manufacturing and other departments to bring new products to market.

  • Works within large cross-functional teams and demonstrates working knowledge of current USDA regulatory guidelines and advanced technical knowledge.

  • Develops project charters and project plans and align with all sponsors and stakeholders. Key capabilities include standard project management activities: development of timelines, use of project tracking tools, definition of deliverables, definition of roles and responsibilities, risk identification tracking and mitigation.

  • Coordinates and tracks team activities by leading or participating in core team meetings, communicates project risks and status to appropriate stakeholders and escalates issues to sponsors as needed in advance of deviation from project plans.

  • In concert with Commercialization, Quality, and Regulatory, support inspection readiness for new product introductions and transfers.

  • Assures consistent application of standardized work, engineering and process tools.

  • Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.

  • Creates and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.

  • Displays our Company's leadership behaviors and demonstrate a high emotional intelligence.

  • Effectively collaborates with peers on site and above site as required. Contributes to international projects (Global Projects). Interacts closely with fellow scientists from your own and other departments. If required with external collaboration partners.

  • Actively contributes to the improvement or acceleration of activities within the department, also in the field of Environment Health and Safety.

  • Trains and guides employees and / or trainees.

  • Performs off-shift work (only as needed).

Education Minimum Requirement:

  • Bachelor’s degree in Biochemical Engineering, Biotechnology, Chemical Engineering, Biology, Biochemistry, Protein Chemistry, Microbiology +2 years’ experience in vaccine/biopharmaceuticals Research and Development, Process Development and/or Biological manufacturing or closely related field (or Master degree +1 years’ experience or PhD in related field).

Required Experience and Skills:

  • Excellent written and oral communication skills.

  • Excellent project management, documentation and writing skills.

  • Excellent teamwork skills.

  • Strong problem-solving skills and a hands-on approach to solving problems inclusive of diverse perspectives (e.g. safety, compliance).

  • Can work together in multidisciplinary and international teams.

Preferred Experience and Skills:

  • Experience in bioprocess scale up and vaccine manufacturing.

  • Working knowledge of USDA regulations.

  • Knowledge of GMP requirements for manufacture and testing of biological products.

  • Understanding of statistics and application to process monitoring and control.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at [email protected]

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster at https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEOC GINA Supplement​ at https://www.eeoc.gov/sites/default/files/migratedfiles/employers/eeocgina_supplement.pdf

OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R63258

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