Senior Scientist Analytical Development

Morristown, NJ - USA

Monthly Salary: Not Disclosed

Posted on: 2 hours ago

Vacancies: 1 Vacancy

Job Summary

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. 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: Senior Scientist - Analytical Development

Location: Morristown NJ 07962

Duration: 12 Months

Job Type: -Temporary Assignment

Work Type: Onsite

Job Description:

DEPARTMENT/TEAM DESCRIPTION

Consumer Health Research & Development (R&D) Development Center in Morristown NJ is focused on development of over-the-counter drug products in categories of Allergy Cough & Cold Pain & Cardio.

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 Bachelors degree in Science or international equivalent with a 7 years of proven Pharmaceutical Analytical Laboratory experience.
A Masters 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:

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.

Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in th...