Supervisor, QC Microscopy

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

I.    JOB SUMMARY 

Supervise and organize microscopists in microscopy testing, review microscopy reports, and ensure compliance with current regulatory standards.  Ensures on-time delivery of testing and key performance metrics. The Microscopist Supervisor is responsible for maintaining a safe and professional work environment.    The individual may also perform SOP generation and revision, investigation, and implementation of new microscopist programs as needed.  The Supervisor maintains strong relationships outside of their own area of expertise and applies a broad scope of knowledge to support the Quality department in contributing to organizational goals. Performs testing and benchwork per cGMP as needed to support operations. Typical hours are 8:30am – 5:00pm, Monday through Friday.  Hours may vary to meet business and training needs and may include weekend work.  

II.    ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
•    Supervise operational activities of laboratory personnel in an organized and efficient manner to prevent any delays in microscopy testing.
•    Author/Review/Approve microscopy technical reports to support investigational conclusions and regulatory communications.
•    Author/Review/Approve protocols, deviations, and investigations.
•    Train personnel on department procedures and testing methods and protocols
•    Represent department in meetings with Production, QA/RA, Packaging, and other related departments.
•    Advise, recommend, and implement resolutions for quality issues and non-compliance.
•    Responsible for the review and interpretation of data, laboratory equipment and records as required to support product release, and studies. Prepare process and status reports, and reviews documents for accuracy and completeness, as well as create clear and technically sound reporting for internal and external stakeholders. 
•    Review forensic and microscopic identification assays and prepare data trend analyses. Key contributor to the monthly trend reports for particles.
•    Ensure that all equipment is fully calibrated and validated.
•    Identify and recommend equipment, supplies, and vendors for microscopic analyses.
•    Perform schedule responsibilities to ensure critical QC metrics are consistently accomplished for product turnaround Participate in interviewing process for hiring supporting staff.
•    Perform all work per cGMP.
•    Participate and attend professional seminars, conferences, and conventions. 

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
Education and Experience: A minimum of a B.S. in Forensics, Chemistry, Biochemistry, Biology, or related scientific discipline with a minimum of 5 years’ experience.   

Must have sound scientific background in microscopy, forensics, microbiology and typical quality control applications.  Must demonstrate a knowledge and familiarity with a GMP Quality Control environment.  Must have experience in and demonstrate broad knowledge in microscopy techniques and characterization of particles.  Must have experience with work related to quality systems and quality control change management.

Demonstrates knowledge and application of typical regulatory guidance such as cGMPs/GLPs, ICH, FDA, EMA, and CMC documents, including PDA and other industry guidance or technical reports.   Demonstrates knowledge microscopy and particle identification/classification and quality control, and data integrity principles.  Demonstrates knowledge of quality control regulatory requirements.  Expected to be familiar with CFR, USP, EU, and JP regulatory requirements.  Demonstrates solid communication and presentation skills.  Demonstrates cross functional understanding and result-driven abilities. 

Must be highly organized, detail oriented, and able to manage multiple projects and work with cross-discipline personnel.  Must be capable of independent management of long-term projects.  Expected to make independent decisions for near-term goals.  Strong problem solving and root cause analysis skills.  Strong analytical and strategic thinking skills are expected. Strong writing and communication skills are expected.

IV.     PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill. 

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
 

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
 

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.