ARL Bio Pharma is the leading pharmaceutical testing Company in the country with a well-earned reputation for premium customer service and quality science. The Senior Microbiologist position offers the opportunity to play a key role in our laboratory. As a Subject Matter Expert with limited oversight, will perform advanced testing of compounded sterile and non-sterile pharmaceuticals. Leverage an in-depth understanding of microbiology processes to independently troubleshoot and resolve complex testing and organizational issues. Communicating with clients and interdepartmental teams on non-routine and complex details of testing and Company processes including requirements and requirements of each specific test. May also be trained to assist in Data Review as needed.
This role requires strong leadership and communication skills to mentor junior staff. This position will assist the Laboratory Associate Supervisor with training and coaching new and junior department staff on specifically assigned tests and work area procedures.
As a strategic partner, this position will advise supervisors on the outcomes of tests and causes of non-pass results. Contribute to the overall success of the department and business through understanding, interpreting, and developing innovative solutions and best practice recommendations. May at times lead to less experienced personnel in strategic projects.
Work Restrictions
Because of the vital and exacting nature of our work and federal regulations, we do not allow medical marijuana cards, and we do random drug testing on all our employees.
Key Benefits
- 100% Company-paid Medical, Dental and Vision Insurance
- Matching 401K Retirement Contributions
- Free Lunch Daily
- Opportunities afforded by an organically growing company
- Generous paid time off
- Opportunity to work with amazing people and play a key role in making America safer
Expected Hours of Work
Days and Hours of Work vary by assigned group and tasks depending on business needs. The schedule will be discussed with the supervisor for the needs of the company and department. Some Flexibility is required as occasional extensions outside the normal schedule. and weekends may be necessary to meet business needs.
Key Responsibilities
- Completion of various complex and non-routine microbiology tests including compounded sterile and non-sterile pharmaceuticals.
- Review Bacterial Endotoxin Tests for Category 2 and 3 compounded sterile preparations and use endotoxin challenge vials to determine if drug products are non-pyrogenic.
- Review Closed and Open Membrane Filtration test data to check for quality control of Sterile testing for clients.
- Using techniques such as gram stain reaction, morphology, and metabolic reaction to isolate microorganisms for accurate identification and testing, to determine causes of contamination in clients' samples.
- Answer clients' advanced non-routine complex calls that involve detailed analysis of testing and results, via email or phone, promptly and professionally that reflects the department and company.
- Train, mentor, and coach laboratory personnel on specifically assigned tests, and procedures.
- Participate in discussions with cross-department personnel and external agencies to assess advanced technical and operational issues from sample and project testing to results and SOP statements.
- Answers specific testing questions requests by clients and cross-department personnel explaining processes, requirements, and regulations.
- Assist Laboratory Associate Supervisors with administration work and Specialty Projects as deemed necessary or assigned.
- Compile routine and cyclical reports for the department.
- Strict Adherence to Standard Laboratory Operations, Quality Management Systems (QMS), and cGMP guidelines.
- Maintains current knowledge of trends and developments in techniques and technology relevant to the field and stays current on industry, company, and departmental methodologies, terminology, and regulations.
- Manages chemicals with the classifications of Toxic, Corrosive, Flammable, or Oxidizing.
- Adhere to, use, and maintain Personal Protective Equipment (PPE) and Laboratory Safety Equipment and identify hazards that may arise.
- Ability to wear a full-face respirator in addition to standard Personal Protection Equipment.
- Complete all safety training including but not limited to OSHA, Departmental SOPs, and Company Compliance.
- May also be trained to assist in Data Review as needed.
Key Skills, Abilities & Success Factors
- Deep Knowledge of Microbiology and Testing Methodology. This position will perform various complex and detailed microbiology tests. Acts as a subject matter expert for the department and company.
- Technical Expertise: This position must understand laboratory and scientific equipment and terminology.
- Leadership: This position at times mentor’s department employees on department and industry terminology.
- Analytical/Problem-Solving Skills: This position will need to be able to analyze and interpret data from specific various tests including sterility, fungal, and endotoxins, and at times determine why the data is not consistent with expectations.
- Organization Skills: This position interacts with and maintains multiple samples that require strict controls.
- Collaboration Proficiency: This position will work at times independently and within a team environment.
- Time Management: This position deals with many time-sensitive tasks, which must be completed in highly time-sensitive deadlines.
- Detail Proficiency: This position's work at times will be repetitive, yet each time strong attention to detail and accuracy is required.
- Professional Verbal and Written Communication: This position interacts in person, by email, and by telephone with external and internal agencies and must demonstrate a professional manner reflecting the company image.
- Digital Literacy: This position uses MS Office applications and Laboratory Information Management System (LIMS) daily and must be able to navigate digital and web-based applications.
- Intercultural Sensitivity: This position will work with diverse populations of characteristics and must demonstrate recognition of the value of diverse backgrounds, experiences, and abilities.
Minimum Qualifications
Bachelor’s degree in Microbiology or equivalent Diploma with 4 years of experience in a microbiology laboratory setting performing detailed microbiology tests.
Supervisory Responsibility
This position has no direct reports. This position supplies much-needed mentorship and leadership to the department as a subject expert.
Work Environment
- This job operates in a professional Laboratory environment using typical protection equipment (Eye protection, Gloves, Lab Coats, etc.) as well as at times respirator and/or Cleanroom suit as appropriate.
- This role routinely involves standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.
- Essential duties of laboratory environment with periodic exposure to chemicals, solvents, and other environmental substances and conditions including but not limited to odors, and varying temperatures.
- Exposure to the use of chemicals with the classification of Hazardous, Toxic, Corrosive, Flammable, or Oxidizing.
- The noise level is moderate.
- Primarily dominated English-speaking workplace.
- Attendance at the office is required.
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential functions.
Physical Requirements
- This is an active role; walking between buildings and different floors daily and some filing is required.
- This position would require the ability to lift 50 Lbs. (If an object weighs more than 50 Lbs. ARL requires this to be a two-person job or use of carts).
- Routinely stand and walk in operations of duties for periods of up to 5 hours at a time.
- Ability to stand or occasionally sit in front of a computer and/or laboratory equipment for extended periods, with intermittent twisting/bend to reach instruments or supplies surrounding equipment. Routinely stand and walk in operations of duties.
- Ability to use hand strength and finger dexterity to perform grasping and fine manipulation of precise equipment.
- Operation of standard office equipment.
- Must be fluent in written and spoken English to receive and communicate information for standard and complex operations and emergencies clearly and accurately.
- Requires visual acuity to read and write words and numbers and to see in the normal visual range including ability to distinguish colors and shapes with or without correction.
- Requires hearing communications accurately with or without correction.
- May require the ability to use a full-face respirator kit for extended hours as required.
- May require the Ability to wear a full Clean Room Suit as directed by supervisor.
AAP/EEO Statement
ARL Bio Pharma, Inc. provides equal employment opportunities to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, gender identity, national origin, disability, veteran status, genetics, or any other characteristic protected by state, federal, or local law. ARL Bio Pharma, Inc. expressly prohibits any form of workplace harassment based on race, color, creed, religion, gender, age, sexual orientation, gender identity, national origin, disability, veteran status, genetics, or any other characteristic protected by state, federal, or local law. Improper interference with the ability of ARL Bio Pharma, Inc. employees to perform their job duties may result in discipline up to and including discharge. Further, the company takes affirmative action to ensure that applicants and employees are treated without regard to any of these characteristics.