Responsible for compliance of studies under the principles of GxP.

May act as Study Director with responsibility for the scientific conduct of GLP studies.

May 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.

Assist in site visits (Technical and QA), complete client requests and addressing 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.

Act as point of contact for departmental training, ensuring training modules are up to date and 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.

Masters Degree in a Scientific discipline (e.g., Biology, Chemistry, Microbiology) with 1+ years of lab experience.

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.

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