Scientist, Analytical R&D (GMP Microbiology Data Review/Investigation Support) - Onsite

Job Description

Small Molecule Analytical Research and Development (SMARD) is seeking a highly motivated Scientist- GMP Microbiology Investigation Support /Data Reviewer to join the growing Microbiology Center of Excellence (COE).  Based at our Company Headquarters in Rahway NJ. This position is responsible for supporting our Company's Portfolio which includes small molecule, biologics and vaccines.  Responsibilities include investigation authoring in support of microbiological testing and manufacturing/ utility (environmental/water) deviations. This position will also be required to review GMP microbiological data from product and utility testing.  While working within a fast-paced, integrated, multidisciplinary team environment, the candidate is expected to have a strong working knowledge of theories, practices and procedures in discipline and will build their own team effectiveness skills.

Minimum required education:

• B.S. in Microbiology or related Biological Sciences and at least 3-4+ years industry experience.

Required experience and skills:

• General understanding of GMP microbiology testing (Sterility, microbial enumeration, tests for specified microorganisms, bioburden, environmental monitoring) and documentation including compendial requirements (USP/EP).

• Desire and willingness to learn, contribute as part of a team with cross-functional interactions.

• Support of GMP microbiological testing deviations (investigation writing/ testing).

• Ability to troubleshoot and critical thinking.

• Ability to think logically and be proactive under pressure.

• Strength in delivering results on firm deadlines in support of our pipeline.

• Availability for occasional weekend work as needed

Expectations

• Contributes expertise and creativity to the collective knowledge and aids in solving project problems.

• Focuses on applying technical skills to data review responsibilities and act as an individual contributor with significant autonomy day to day.

• Responds to standard requests from partners, customers and clients (internal and/or external).

• Team collaboration to achieve objectives and meet deadlines.

• Ability to execute projects and deliver on priorities through strong individual contributions.

• Contributes to technical and/or business deliverables with direction

#eligibleforERP

#AR&D

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts