Scientist II

Piramal Pharma Solutions Inc.; Lexington (KY); On-site; USD 65,000 - 85,000; Full time

Job summary

Piramal Pharma Limited, a leading pharmaceutical development and manufacturing organization, seeks an Analytical Scientist II to perform complex chemical and physical testing of raw materials and finished products in Lexington, KY. The role focuses on method development, transfer, verification, and validation using HPLC, GC, KF, and dissolution techniques.

The candidate will document results, prepare regulatory filings, and interact with clients as needed, ensuring compliance with lab procedures

Qualifications

• BS, MS or PhD in Chemistry, Biochemistry or Pharmaceutical Science or related.
• 2+ years’ Pharmaceutical industry experience preferred.
• Experience with potent, cytotoxic materials a plus.

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

Skills

Analytical testing

Regulatory GMPs

Data documentation

Communications

Education

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

Tools

HPLC

GC

KF

Dissolution

Spectroscopy

Job description

Be the First to Apply Job Description Scientist IIBusiness: Pharma Solutions Department: Analytical R&D (ARD) Location: Lexington, KY

Business: Pharma Solutions Department: Analytical R&D (ARD) Location: Lexington, KY

Job Overview 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 Directly reports to 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

Experience

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

Work Experience

• BS with 2+ years’ Pharmaceutical industry experience or similar
• Experience working with potent, cytotoxic materials and parenteral drug products preferred

Competencies

• 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

Physical Demands

• Must use hands to handle, feel, reach, type or operate objects or controls
• Frequent sitting, talking, reading or hearing
• Frequent walking or long periods of standing, bending, pushing and pulling
• Long periods of sitting, typing, or working at a computer station

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.