R&D Mfg Scientist II - Analytical Development

Work Schedule

Environmental Conditions

Job Description

GROUP/DIVISION SUMMARY

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

POSITION SUMMARY

Provides routine analyses in a biochemistry environment within defined procedures and practices. Performs analytical methods for moderately sophisticated testing on samples, stability, and production intermediates to support process development and/or manufacturing operations. May research and implement new methods and technologies to improve operations. Makes detailed observations and reviews, documents, and communicates test results.

Key Responsibilities:

• Lead the validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, potency, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, using HPLC, GC, LC/MS, and compendial testing.
• Recognize and report out-of-specification or unexpected results and non-routine analytical and product problems.
• Write deviations, OOS, CAPA, Change Controls, SOP and specification documents.
• Perform daily instrument calibrations/verifications as required.
• Write and complete validation protocols in accordance with regulatory guidelines
• Review and interpret analytical test results; make recommendations based on data
• Run projects at the broad task level under supervision, ensuring deliverables are met and next steps are clearly identified.
• Participate in meetings/teleconferences with clients. Develop methods and processes that meet or exceed the expectations from clients and provide innovation.
• Conducts routine tasks and sample analyses to support process development.
• Performs all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the compliance status required by company and facility standards.

Qualifications:

• Bachelor Degree in Chemistry, Biochemistry, Molecular Biology, or related physical/biological science field minimally required with 3+ years related experience, or
• Masters degree, 1+ year related pharmaceutical industry experience strongly preferred.
• Experience with HPLC and Dissolution.
• Experience performing method development and validation, chemical tests with chromatographic, spectroscopic, or other analytical techniques preferred
• Experience with EMPOWER preferred.
• Equivalent combinations of education, training, and meaningful work experience will be considered.
• Good knowledge and understanding of chemistry and analytical instrumental technologies.
• Good knowledge of qualitative and quantitative chemical or microbiological analysis.
• Awareness of quality and regulatory requirements in the pharmaceutical industry
• Strong interpersonal and communications skills, written and oral
• Ability to read, analyze, and interpret technical procedures and governmental regulations.
• Excellent organization and planning skills.
• Strong attention to detail and ability to implement to standard procedures.
• Ability to design and complete tasks and studies based on the deliverables.
• Ability to accurately detail work and write reports.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.