Study Director Jobs in Washington (NOW HIRING)

Your Role:

As Lab Supervisor 1, you will oversee the daily management of laboratory conducting a wide variety of assays or tests required to characterize product or material safety. This includes supervision of associate scientists, and/or lab technicians in each lab. This also includes oversight and accountability for quality of work, service delivery, financial targets, and other established lab performance targets. You are responsible for the scientific integrity of technical work performed in manufacturing, and are required to ensure scientific observations, detailed workbooks, and all other documentation fulfill generally accepted (GMP/GLP) professional/industry standards. Requirements also include maintaining a thorough understanding of the company manufacturing and testing services, technical principles, and applications as they apply to your position. Specific responsibilities include:

• 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.

Who You Are

Minimum 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.

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

Pay Range for this position: $81,900- $122,800

Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, careerlevel, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.

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