Associate Specialist, Bio Technology Solutions

Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and consumer health products. The Associate Specialist within the Bio Technology Solutions team will focus on process improvement and troubleshooting for vaccine and biopharmaceutical manufacturing, providing technical support and collaborating with various departments to ensure high-quality production.

Responsibilities

• Leads and/or works independently to optimize and/or troubleshoot manufacturing processes for microbial, virus or cell cultures followed by purification/concentration and blending/fill of veterinary vaccines and biopharmaceuticals (antibody therapeutics)
• Leads and/or works independently and/or supports a team member with focus on technology transfer within or between manufacturing sites
• Works at the speed of business to resolve manufacturing challenges while always ensuring timelines meet the requirements of the customer regarding safety, quality, cost-efficiency, practical applicability, and consistency
• Leads and/or 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 working independently or in collaboration with other departments (e.g. Quality, Research, Production, BTS – Analytical and /or Process Development), must ensure sound scientific data/literature/evaluation and integrity drives every decision/recommendation
• Collaborates and interfaces with Research, Process/Analytical Development, Manufacturing and other departments to ensure commercial products are produced to keep up with commercial needs
• Develops project charters and project plans and align with all sponsors and stakeholders
• Key capabilities include project management skills: development of timelines, use of project tracking tools, definition of deliverables, definition of roles and responsibilities, risk identification/tracking/mitigation and business acumen
• Coordinates and tracks team activities by leading or participating in core team meetings, communicates project risks and status to appropriate stakeholders, and escalates challenges as well as opportunities to sponsors at the speed of the business need
• Assures consistent application of standardized work, engineering controls, and process analytical technology
• Authors experimental protocols and reports in support of laboratory or production scale evaluations
• 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 demonstrates high emotional intelligence

Skills

• B.S. or M.S. degree in biochemistry, biochemical engineering, biological systems engineering, biomedical engineering, chemical engineering, mechanical engineering, or related disciplines
• Relevant pharmaceutical industry experience
• Excellent academic record
• Effective verbal and written communication skills, team skills, personal character, and ethics
• Strong problem solving skills and a hands-on approach to problem solving, with a bias towards going to see problems for oneself in the field
• Ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it
• Enthusiasm, confidence, and initiative-taking ability needed for continuous learning and its applications
• Strategic and motivational ambition to succeed and to help others to do the same
• Accountability
• Antibody Therapeutics
• Biological Engineering
• Biomedical Engineering
• Biopharmaceuticals
• Cell Cultures
• Chemical Engineering
• Customer Experience Management
• Data Analysis
• Detail-Oriented
• Engineering Standards
• Equipment Maintenance
• Estimation and Planning
• Field Failure Analysis
• Global Manufacturing
• Identifying Risks
• Mammalian Cell Culture
• Manufacturing Processes
• Manufacturing Quality Control
• Mechatronics
• Pharmaceutical Biology
• Pharmaceutical Sciences
• Process Design
• Process Improvements
• CGMP environment
• Work, co-op, or internship experience in industry

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days

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