Associate Scientist Operations Manager

Must-Have:

• Master’s or Ph.D. degree in life science or related field (preferred).
• 5 years of experience working in a laboratory setting with a focus on Pharmaceutical and/or medical device development and testing using LC/MS, ICP-MS, and GC-MS analysis.
• Comprehensive extractables and/or Impurity ID experience.
• 3 years of people leadership experience in a cGMP laboratory setting required.

Job Summary:

Candidates will work directly with the scientific advisor and chemistry team to maintain systems and processes in a state of compliance with internal, regulatory, and industry standards, to meet cost-effective business needs. This position supports all areas of site scientific operations and may serve as a technical liaison to internal and external customers at the direction of the scientific advisor. Candidates in this role will promote a culture of quality and compliance. Additionally, candidates will apply scientific knowledge to design and conduct analytical testing following project requirements, including but not limited to Extractables Analysis, Leachable Method Development, and Method Validation Projects, while analyzing data/results using LC/MS, ICP-MS, and GC-MS analysis.

Essential Duties/Responsibilities:

• Manage, support, and coach scientists in their work and provide strategic vision.
• Proactively lead in a manner that empowers teams by providing effective guidance and direction, conveying confidence through words and actions.
• Plan, manage, organize, and coordinate laboratory services and daily laboratory activities.
• Subject matter expert and the technical resource for the region in a designated specialized area.
• Monitor laboratory compliance with respect to lab cleanliness, training records, and other ISO/GMP items to help minimize laboratory audit findings.
• Participate in training and development activities in order to advance core competencies and quality knowledge.
• Conduct technical reviews of data and generate, review, and approve reports.
• Guide process improvements & assist in program development.
• Provide support testing for Scientists and assist in Quality investigations.
• Perform analytical testing in accordance with project requirements, including but not limited to protocols, compendiums, Standard Operating Procedures, and other Standard Testing Procedures.
• Provide scientific and/or project execution guidance to other laboratory staff members.
• Create proper laboratory records in accordance with Company procedures and policies.
• Maintain, operate, troubleshoot, and qualify analytical instruments in accordance with Company procedures.
• Conduct investigation of instrument failures or malfunctions.
• Participate in investigations of Out of Specifications (OOS) or unexpected results.
• Provide accurate test results to customers on a timely basis.
• Train others in the maintenance, use, troubleshooting, and qualification of instrumentation.
• Lead method development efforts via expert-level instruments and scientific knowledge basis.
• Participate in the creation or revision of internal SOPs, procedures, policies, or systems.
• Effectively communicate with clients and other external parties.

Education:

• Master’s or Ph.D. degree in life science or related field, or equivalent work experience.

Experience:

• 5 years of experience working in a laboratory setting with a focus on Pharmaceutical and/or medical device development and testing.
• Comprehensive extractible and Impurity ID experience.
• 3 years of people leadership experience in a cGMP laboratory setting required.
• Must be a detail-oriented, problem-solving individual with strong interpersonal, written, and oral communication skills.

Capabilities:

• Ability to motivate and influence others to act in an appropriate business culture and laboratory environment.
• Excellent verbal, written, and interpersonal skills including the ability to interact successfully with internal and external customers.
• Well-red in sciences testing and data analysis.
• Demonstrated ability to carry out independent scientific work.
• Proficient in Extractables Analysis and Leachable Method Development.
• In-depth knowledge of GMP.
• Knowledge of the operation and data workup of LC/MS GC/MS and ICP/MS for the characterization of impurities.
• U.S Work Authorization Required.

Infinity Laboratories is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.