Lab Supervisor 1

About the role

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Responsibilities

• Oversee the daily management of laboratory conducting a wide variety of assays or tests required to characterize product or material safety.
• Supervise associate scientists, and/or lab technicians in each lab.
• Oversight and accountability for quality of work, service delivery, financial targets, and other established lab performance targets.
• Ensure scientific integrity of technical work performed in manufacturing, and ensure scientific observations, detailed workbooks, and all other documentation fulfill generally accepted (GMP/GLP) professional/industry standards.
• Comply with GxP principles and act as Study Director with responsibility for the scientific conduct of GLP studies.
• Act as the study management/ responsible person on the release of test results in a GMP study.
• Document scientific observations and coordinate all activities associated with day-to-day laboratory operations.
• Schedule the conduct of assays by lab staff and coordinate the scheduling samples to be tested.
• Ensure the necessary paperwork is received to facilitate on time lab initiation of studies.
• Review study data for accuracy, adherence to compliance, and completeness of documentation.
• Conduct thorough scientific investigations to determine the root cause for each deviation and nonconformance. Document all aspects of the investigation in a timely manner.
• Liaise with Quality Assurance and appropriate cross-functional departmental areas to close the events and corrective actions identified during GxP laboratory testing.
• Stay current with SOPs and regulations (cGMP and GLP).
• Periodically evaluate laboratory procedures, system controls, and technical documentation such as SOPs and batch records to ensure compliance.
• Manage the use and maintenance of scientific equipment and instrumentation, computer systems; Ensure that they are kept in a calibrated / validated state and part 11 compliant.
• Absorb and respond to client requests, address site visit/ audit findings in a timely manner.
• Participate in conference calls and anticipate/ address client questions as appropriate.
• Provide direct supervision to Associate Scientists and/or Laboratory Assistants.
• Meet with direct reports to set goals, conduct regular one-on-one discussions with employees, ensure development plans are in place for all employees, address personnel issues promptly, interview and hire new candidates and complete performance reviews fairly and on-time.
• Assemble and maintain training modules, ensure training matrix reflects staff capabilities.
• Participate in division-wide initiatives including Quality systems improvements, trans-divisional SOPs revisions, Lean projects, etc.
• Perform other duties and responsibilities as appropriate or required.

Requirements

• Masters Degree in a Scientific discipline (e.g., Biology, Chemistry, Microbiology) with 1+ years of lab experience.
• OR Bachelors Degree in a Scientific discipline (e.g., Biology, Chemistry, Microbiology) with 3+ years of lab experience.
• 1+ years of experience leading and training staff in a laboratory setting.

Preferred Qualifications

• Supervisory/team lead experience in a laboratory setting or scientific industry.
• Working knowledge of analytical chemistry applicable to Quality Control testing within the Product Characterization lab.
• Expertise in HPLC, CE-SDS, and cIEF.
• Strong knowledge of GMP practices, compendial regulations, quality assurance, and compliance standards.
• Proficient with Compass, Empower, Openlab, Chromeleon, and 32 Karat software systems.
• Excellent oral and written communication skills that have been demonstrated through presentations/seminars, oversight of projects, implementation of new services, etc.
• Excellent time management skills.
• Highly collaborative yet able to succeed independently.
• Demonstrate a high level of initiative and leadership capabilities.
• Effective supervisory, coaching, and training skills for complex and highly technical work.

Qualifications

• Masters Degree in a Scientific discipline (e.g., Biology, Chemistry, Microbiology) with 1+ years of lab experience.
• OR Bachelors Degree in a Scientific discipline (e.g., Biology, Chemistry, Microbiology) with 3+ years of lab experience.
• 1+ years of experience leading and training staff in a laboratory setting.

Benefits

• Medical, vision, and dental insurance.
• Life insurance.
• Disability insurance.
• A 401(k) matching program.
• Paid time off.
• Paid holidays.
• Among other employee benefits.

Pay Range

$82,400 - $144,500