Job DescriptionJob Description:
The laboratory groups at Company RTP are responsible for the support of pharmaceutical product
development in a range of dosage forms both directly with customers and in collaboration with
other Company facilities. This includes formulation development, structural chemistry, analytical
support, and clinical trials material manufacturing.
II. Job Summary
Under general supervision, performs work that is varied and that may be somewhat difficult in
character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is
required. Follows established protocols and work plans. May be assisted by laboratory technicians /
assistants. Comply with divisional and site Environmental Health and Safety requirements.
III. Specific Duties, Activities, and Responsibilities
% of time
Lab DRT
1. Execute laboratory work plan / schedule developed with input from supervisor
or senior team member. 70 5
2. May draft technical documents such as methods or certificates of analysis. 10 5
3. Performs parallel review of laboratory documentation and may become
qualified to perform technical review of documents for accuracy, thoroughness
and regulatory compliance
5 75
4. Trains others on procedures and laboratory techniques. 5 5
5. Executes efficiency improvement project with guidance 5 5
6. All other duties as assigned. 5 5
IV. Job Requirements
Education and Experience:
• Master's degree and 0-2 years related experience; Bachelor's degree and 3-5 years related
experience; or Associate's degree and >6 years related experience or equivalent education,
experience, and training
• Maintain high quality laboratory documentation in accordance with applicable regulatory
guidance and Site SOPs
• Ability to learn and retain technical information
• Proactively address work issues at both an individual level and a team level
• Develop and execute procedures or methods with high quality
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule
form
• Mathematical and scientific reasoning ability
• Basic understanding of instrument operations and troubleshooting skills in multiple
techniques
• Ability to identify aberrant/out of spec data and limited interpretation of data expected
• Excellent written and verbal communications skills with internal and external customers
• Lead by example according to Company's values and culture
• Demonstrated ability to lead small team projects
• Recognizes unmet needs within department
• Strategy is focused on personal time management and efficiency
• Well organized with ability to multitask
• Ability to work effectively under pressure to meet deadlines
• Has applied knowledge of the principles and concepts of a discipline.
• Applies technical and functional knowledge to job related duties on most projects/
assignments within own group/project team.
• Propose deviations from established procedures and methods based upon sound judgment.
• May contribute material to publications and/or external presentations
Physical Requirements:
• On an average 8 hour day this position requires the ability to walk, sit and stand, use hands
to handle or feel, reach with hands and arms at or above shoulder height and below waist
height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40
pounds
• Specific vision requirements including reading of written documents, visual inspection of
materials and use of computer monitor screen frequently
• May require the use of a respirator
Job Qualifications:
Education: Bachelor's Degree in chemistry or closely related physical science
Experience: 1-3 years related experience
Knowledge/Skills Requirements:
• Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
• Ability to learn and retain technical information
• Proactively address work issues at both an individual level and a team level
• Executes procedures or methods of moderate complexity with high quality
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Mathematical and scientific reasoning ability
• Basic understanding of instrument operations and troubleshooting skills in multiple techniques
• Ability to identify aberrant/out of spec data and limited interpretation of data expected
• Excellent written and verbal communications skills with internal and external customers
• Lead by example according to Company's values and culture
• Demonstrate leadership capabilities in a matrix environment
• Recognizes unmet needs within department
• Strategy is focused on personal time management and efficiency
• Well organized with ability to multitask
• Ability to work effectively under pressure to meet deadlines
Physical Requirements:
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-40 pounds
• Specific vision requirements including reading of written documents and the use of computer monitor screen frequently
• May require the use of a respirator
Business Environment:
To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description reflects the general duties of the job but is not a detailed description of all duties which may be inherent to this position. Company may assign reasonably related additional duties to individual employees, consistent with company policy.
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