Address
Form of workJob Description
Overview:
Tekwissen Group, is a workforce management provider throughout the USA and many other countries in the world. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world, headquartered in Leverkusen, and areas of business include pharmaceuticals; consumer healthcare products, agricultural chemicals, seeds and biotechnology products.
Job Title: Scientist (Expert)-Chemical R&D-R&D-CS
Location: Morristown, NJ, 07962
Duration: 12 Months
Job Type: Contract
Work Type: Onsite
Job Description:
POSITION SUMMARY
- The Sr. Scientist Analytical Development performs extensive laboratory work to support pre-formulation, formulation development, technology transfer activities, clinical trials, and evaluation of product performance and stability.
- The Sr. Scientist, with minimum supervision, manages projects to ensure all tests are completed on time, results are accurate, and all activities are documented.
- The Sr. Scientist effectively communicates to all stakeholders the analytical activities and findings.
POSITION DUTIES & RESPONSIBILITIES
- Performs extensive laboratory work to support pre-formulation, formulation development, technology transfer activities, clinical trials, and evaluation of product performance and stability.
- Conducts analytical method development, method validation and transfer
- Performs analytical laboratory work to support product development
- Accurately and timely documents the experiments and results into the notebooks, ELN and LIMS (if required)
- With minimum supervision, manages projects to ensure all tests are completed on time, results are accurate, and all activities are documented.
- Effectively communicates to all stakeholders the analytical activities and findings.
- Follows SOPs/OIs and analytical laboratory practices to ensure the work quality and compliance
- Writes the analytical methods, specifications, method validation reports, experimental reports, and SOPs/OIs
- Performs GMP comprehensive review of analytical activities such as but not limited to method development, method validation, method transfer, testing of analytical product development batches, process optimization batches, stability submission batches and instrument technical records
- Interacts with analysts on the data review to recommend appropriate corrections / modifications / improvements needed to build consistency with respect to documentation practice guideline
- Perform other duties as assigned
REQUIREMENTS/PREFERENCES
Education Requirement(s):
- A Bachelor's degree in Science, or international equivalent, with a 7+ years of proven Pharmaceutical Analytical Laboratory experience.
- A Master's degree or higher in Science, or international equivalent, with a 5+ years of proven Pharmaceutical Analytical Laboratory experience.
Skill & Competency Requirements:
- Must have QC or R&D experience in pharmaceutical industry
- Specific Hands-on experience with Waters & Agilent HPLC / UPLC and dissolution apparatus (USP Type 1 and 2)
- Understands fundamental analytical chemistry and chromatography.
- Able to troubleshoot testing and/or analytical method related issues.
- Understands and follows GMP / SOP requirements
- Familiar with analytical laboratory documentation practices
- Expertise in Waters Empower3 CDS.
- Expertise in MS Office, such as Word, Excel, and PowerPoint.
- Good communication and interpersonal skills
- This individual must be highly motivated, have a positive "can-do" attitude and the ability to work in a fast-paced environment as a collaborative team player
- Practical knowledge and experience with application of analytical method development and method validation activities.\
Preferences:
- (list nice-to-haves such a specific knowledge items, certifications, skills, abilities, etc.)
- Go the extra mile to get things done at high quality
- Ownership of the work
TekWissen Group is an equal opportunity employer supporting workforce diversity.
