Career Opportunities

We are looking for talented and dedicated individuals for our team. If great ideas inspire you, perhaps there’s a place for you at PuraCap. You’ll enjoy a challenging environment, terrific colleagues and all the opportunities your drive and initiative can handle.

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Pharmaceutical Chemist

WORK LOCATION:    South Plainfield, New Jersey

DUTIES:

1. Develop and validate analytical methods for Dissolution, Assay, Impurities, Residual Solvents and Cleaning Verification for drug substances and dosage forms such as tablets, capsules, suspensions and oral solutions using various techniques like HPLC, UPLC, GC, UV, etc.
2. Design protocols for method validation, method transfer, and stability studies.  Review analytical reports and SOPs to ensure the conformance of applicable regulatory guidelines.
3. Develop optimum formulations and evaluate product stability and trend analysis of data.
4. Serve as a technical resource in support of Out of Specification (OOS) and deviation investigations.
5. Lead contributions to regulatory filings.  Prepare CMC documents and sections for pharmaceutical regulatory submissions as per the ICH and FDA guidance.  Respond to the queries in a timely manner.

6. Conduct internal audits to ensure quality and adherence to GLPs and cGMPs.
7. Evaluate and assess the regulatory impact of changes to the controlled documents.
8. Work with Process Development team and Manufacture to trouble-shoot process challenges.

EDUCATION AND EXPERIENCE REQUIREMENTS:

• MS in Pharmacy, Chemistry, Biotechnology or related.
• At least 2 years of experience in the job offer or related occupation as CMC Support

Specialist or Senior Chemist.

SPECIFIC SKILLS AND OTHER REQUIREMENTS:

1.     Proficiency in:

• Analytical Method Development and Validation
• Wet-chemistry along with knowledge of GLP/GMP

2.     Must be familiar with:

• Regulatory Submissions, FDA and ICH Guidelines
• CMC regulations

3.     Ability to assess regulatory risk/benefits and provide regulatory strategies for pharmaceuticals.

4.     Must have participated in Regulatory Affairs Certificate Program or related programs.

5.     Technical skills required: HPLC and GC Analytical Method Development, UV Spectroscopy, Stability Testing, Dissolution, Electrophoresis, GMP & GLP, Compliance and Audits, and Project Management.

PuraCap Pharmaceutical LLC is an equal opportunity employer and affords equal opportunity to all applicants and employees for all positions without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other status protected under local, state, or federal laws.

If interested in applying for any of the above posted positions at PuraCap, please send your Resume/CV to: humanresources@puracap.com