R&D/Mfg Scientist II

Work Schedule

Environmental Conditions

Job Description

POSITION SUMMARY

The R&D Scientist II provides routine analyses in a chemistry and 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/Execute the development, evaluation, validation and transfers of test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, potency, and dissolution by HPLC, GC, IEF, CGE and compendial testing

Execute testing for pharmaceutical raw materials and finished products for strength, impurities, identity, potency, and dissolution by HPLC, GC, IEF, CGE and compendial testing

Recognize and report out-of-specification or unexpected results and non-routine analytical and product problems

Determine if reported data meets specification or expected standards

Demonstrate advanced knowledge and experience in Empower

Demonstrate knowledge in methodvalidation/transfer/evaluation/development

Perform daily instrument calibrations/verifications as required

Perform cGMP analytical data review for various techniques to ensure adherence to established procedures, analytical standards, GVLs and SOP

Ensure that all laboratory testing and activities are carried out in compliance with regulations, ICH guidelines, and USP/EP Pharmacopeia, GMP and  data integrity requirements

Might Author and/or review: OOS investigations, Deviations and Change Controls, technical reports, Protocols and validation summaries , SOPs, specification documents

Ensure all job-related safety training and compliance requirements are met

Might assist in trainings as an SME

Communicate with Project Lead/Management concerning project status and/or concerns

Strong attention to detail and organizational skills

Must be able to set project priorities and time management in order to maximize productivity

Actively participate in ongoing trainings and seek out opportunities to increase contributions for development of skills and responsibilities

Might 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

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

Master’s degree, 1+ year related pharmaceutical industry experience strongly preferred.

Experience with HPLC.

Experience with HPLC, GC, Dissolution, FT-IR, UV, Karl Fischer Titration, IEF, ELISA, CGE, Dot-Blot  preferred

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.

Fluent in English

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.