Microbiologist II

Hikma Pharmaceuticals USA Inc.•Cherry Hill, NJ

7d•Onsite

About The Position

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. JOB PURPOSE: Conduct critical microbiological analysis on test articles from all stages of the manufacturing process from incoming raw materials to finished products as well as water system testing. Execute test method validation under the direction of supervision. Write/revise standard operating procedures, forms, protocols, and investigation reports. The duties also include equipment maintenance and LIMS management.

Requirements

BS/BA Degree in Microbiology or Biology
2 - 5 years pharmaceutical microbiology experience
Microbiology coursework and laboratory work utilizing aseptic technique
Computer literate
Must have excellent writing skills to write clear and concise reports

Nice To Haves

Knowledge of pharmaceutical microbiological methods and cGMPs as well as an understanding of scientific principles

Responsibilities

Conduct critical microbiological analysis on test articles from all stages of the manufacturing process from incoming raw materials to finished products as well as water system testing.
Execute test method validation under the direction of supervision.
Write/revise standard operating procedures, forms, protocols, and investigation reports.
Equipment maintenance and LIMS management.
Use sophisticated laboratory instruments and computer systems to collect and record data.
Perform advanced laboratory assays requiring precise analytical and aseptic technique skills.
Perform review of test data, which includes overall documentation practices.
Maintain data integrity and ensure compliance with company policies, procedures, cGMPs, and regulatory requirements.
Execute test method validation for new active pharmaceutical ingredients and finished drug products.
Support GMP equipment qualification testing and laboratory equipment validation testing.
Work on special projects and protocol testing that involves new methods and instrumentation.
Complete all special projects and protocol testing in a timely and appropriate manner.
Investigate deviations and write laboratory investigation reports for OOS results.
Write/revise standard operating procedures, forms, and protocols.
Communicate issues to supervision and between departments as appropriate.
Communicate effectively with co-workers to ensure all required tasks are completed as expected.
Cross-train within different groups in the microbiology laboratory.

Benefits

Annual performance bonus
commission
share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay.
Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date).
Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave