Onsite in New Berlin, NY
(Relocation Offered)
Company Profile: Our client is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brand, over-the-counter brands (OTC) and biosimilar products for patients around the world.
What You Can Expect To Be Doing
• Lead and manage activities supporting the laboratory function in executing daily operations and testing necessary to support commercial products.
• Anticipate and resolve problems independently while conforming to SOPs and GMP regulations
• Monitor the scientific and financial progress of projects that they are assigned
• May have responsibility for a laboratory group or function and may have direct reports
• Participate in weekly/monthly safety training, identify potential safety hazards, implement appropriate safety improvements and take part with investigations of safety related incidents
• Perform job functions in a safe manner consistent with site safe practices and regulatory (e.g. -OSHA) requirements
• Conduct assigned tasks in compliance with cGXP requirements, current industry standards, compendial standards, FDA expectations and internal procedures
• Ensure investigations are conducted in a timely manner and are completed within established target completion dates
• Ensure that the Quality Control staff have been appropriately trained before performing a GMP task
• Serve as primary resource for planning and scheduling of tests
• Assist analysts as needed and troubleshoot if required
• Witness analytical notebooks of peers
• Conduct testing consistent with established methods/procedures
• Schedule and/or perform necessary validation, qualification and calibration of laboratory equipment/instruments
• Schedule method development, qualification, verification or validation according to established SOPs as well as FDA/USP/ICH guidelines
• Custodian of laboratory systems and is proactive in implementing significant system improvements and / or laboratory procedures
• Communicate with clients, contractors, and regulatory agents as required
• Provide leadership and guidance to laboratory system owners and removes barriers to enable positive change
• Function as the laboratory representative on multi-department project teams
• Familiar with department and plant systems and effectively operates within systems to achieve desired results
• Serve as backup to the Manager, Quality Control
• Staff Development / Training
• Identify areas of improvement in laboratory testing
• Provide technical training to analysts
What You Will Bring To The Table
• BS in Chemistry, Biochemistry, Biology or Microbiology or related discipline
• 5+ years’ experience in a laboratory environment (quality control or similar pharmaceutical industry experience preferred), or MS in Chemistry, Biochemistry, Biology or Microbiology or related discipline and 3+ years’ experience
• Thorough understanding of cGMP requirements
• Strong communication, interpersonal, and organizational skills
• Ability to work with a sense of urgency in a fast-paced environment
• Strong technical writing and investigational skills
Please reach out to Lisa Gabor at LisaG@ScientificSearch.com to learn more about this phenomenal opportunity!
#IND1
Location: New York
Posted: Sept. 23, 2024, 8:44 p.m.
Apply Now Company Website