Microbiologist II 503B - East Windsor, NJ - Empower Pharmacy

Position Summary:

The Microbiologist II role is critical in ensuring the quality and safety of Empower’s pharmaceutical products, playing a key role in supporting our values of service, quality, and innovation. This position contributes significantly to the company's commitment to excellence by conducting and reviewing microbiological testing on raw materials, finished products, and environmental samples, ensuring that all procedures meet regulatory standards and uphold the highest levels of product safety

 

In this role, you will take on complex laboratory investigations, helping to identify root causes and implement corrective actions for any out-of-specification results. Your work will include developing and validating microbiological test methods, ensuring accurate documentation, and adhering to rigorous safety and compliance standards, including Current Good Manufacturing Practice (cGMP). You will also collaborate with cross-functional teams, providing valuable insights and technical expertise to help drive continuous improvement in the lab's processes and procedures.

 

This role offers an exciting opportunity to contribute to the research, development, and optimization of microbiological practices within an innovative laboratory environment. Empower is dedicated to producing innovative medications that improve lives, and we invite experienced microbiologists passionate about scientific rigor and quality assurance to join our team. Your work will play a vital part in expanding access to affordable, high-quality healthcare for people everywhere.

Duties and Responsibilities:

• Conducts and reviews microbiological testing of raw materials, finished products, and environmental samples, including microbial enumeration, identification, and antimicrobial effectiveness testing.
• Conducts laboratory investigation (Out of Specification) on root causes and implementation of proper actions.
• Documents experimental procedures, results, and observations in detailed laboratory notebooks, and prepares technical reports, presentations, and scientific publications.
• Evaluates findings, contributes insights to research discussions and project meetings, and communicates research findings and progress updates clearly.
• Develops and validates microbiological test methods in accordance with regulatory requirements, and maintains accurate records of testing, reports, and procedures.
• Adheres to laboratory protocols, safety guidelines, and regulatory standards, ensuringcompliance with cGMP requirements, Good Laboratory Documentation Practices, and participating in internal and external audits.
• Supports microbiology-related projects, implements best practices and innovative solutions, and identifies opportunities for process improvements and optimization within the laboratory.
• Adheres to personal hygiene, garbing and Personal Protective Equipment standards per United States Pharmacopeia regulations when working inside of the sterile and nonsterile hazardous and nonhazardous labs.
• Performs other duties as assigned.

 

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

Knowledge and Skills :

• Knowledgeable of microbiological testing techniques, methods, and equipment.
• Proficient with microbiological method development and method validation procedures like bacterial endotoxin testing, Sterility, microbial limit testing, biological assay and disinfectant qualification and microbiological hold time validation, Container closure integrity validation.

 

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

 

Values

• People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
• Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
• Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.
• Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.

Experience and Qualifications :

• Bachelor's degree in Microbiology, Biology, Biochemistry, or related field required.
• Minimum 3 years of experience in a microbiology laboratory required.
• Previous experience in a pharmaceutical or compounding environment required.
• Experience with compendial testing: United States Pharmacopeia and regulatory requirements (Food and Drug Administration and cGMP) required.
• Experience with regulatory and safety standards preferred.

Benefits:

• No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.
• Onsite Health & Wellness – IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.
• Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
• Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.
• Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.
• Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.
• Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance.
• FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).
• 401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
• Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time.
• Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.
• Rewards & Recognition Program: Your hard work doesn't go unnoticed – enjoy rewards and recognition beyond your paycheck.

 

Additional Voluntary Benefits

• Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.
• Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.
• Critical Illness: Protect your finances from the expenses of a serious health issue.
• Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.
• Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.
• Legal Services: Access professional legal assistance to address concerns confidently.
• Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.
• Pet Insurance: Care for your furry family members with our pet insurance coverage.
• Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.