Scientist II

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Scientist II

Job Description

Business: Pharma Solutions
Department: Analytical Development
Location: Lexington

Job Overview

Reporting to the Associate Director, Analytical R&D, the Analytical Scientist II conducts complex chemical and physical testing of pharmaceutical raw materials and finished products. Executes proficiency in development and transfer/verification/validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, and identity.

Reporting Structure

This position reports to the Associate Director, Analytical R&D

Key Responsibilities:

• Conducts complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods.

• Executes proficiency in development and transfer/verification/validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, KF, spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, dissolution, KF, spectroscopy, and/or traditional wet chemical testing under general supervision

• Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems; recommends solutions

• Maintains and troubleshoots analytical instrumentation as needed

• Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems. May interact with clients.

• Prepares and assists in filing regulatory documents in support of internal projects and may provide communications with outside departments, corporate sites, agencies, and clients.

• Writes SOPs and other instructional documents

• Cleans and organizes work area, instrumentation, and testing materials

• Maintains the necessary compliance status required by company and facility standards

Qualifications:

• BS, MS or PhD in Chemistry, Biochemistry or Pharmaceutical Science or related

• BS with 2+ years’ Pharmaceutical industry experience or similar

• Experience working with potent, cytotoxic materials and parenteral drug products preferred

• Proficiency using chemistry and analytical instrumental technologies

• Knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry.

• Demonstrated proficiency approaching in solving scientific problems

• Proficiency with HPLC, GC, KF and dissolution techniques

• Good interpersonal and communication skills (both oral and written)

• Ability to respond to common inquiries or complaints from customers or regulatory agencies

• Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance and correlation techniques