PuraCapSr. Scientist I of AR&D

Career Opportunities

We are looking for talented and dedicated individuals for our team. If great ideas inspire you, perhaps there’s a place for you at PuraCap. You’ll enjoy a challenging environment, terrific colleagues and all the opportunities your drive and initiative can handle.

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POSITION DESCRIPTION

Title:	Sr. Scientist I of AR&D
Position Type:	Full-time
FLSA Status:	Exempt
Job Code:
Department:	Analytical Research and Development
Effective Date:

A. POSITION SUMMARY:

Successful candidate will be responsible for carrying out and leading current analytical method activities and testing for new products and line extensions for the company, with focus on release and stability indicating methods for oral solid dosages (capsule, tablet, softgel etc.)

B. MAJOR DUTIES/RESPONSIBILITIES:

Perform wet chemistry and chromatographic testing for products under development phase for conformance to established specifications, with most emphasis on HPLC and dissolution testing.
Carryout wet chemistry and chromatographic analytical method comparisons, analytical method verifications, analytical method transfers and analytical method development and validation as requested, and draft protocols, reports, and final methods.
Perform wet chemistry and chromatographic analytical activities to support in-house formulation screening and development.
Carryout associated stability studies and generate stability protocols and reports.
Develop and validate cleaning methods and generated study protocols and reports.
Maintain proper instrument calibration status.
Actively participate in the preparation of regulatory submission dossier with focus on CMC module and analytical package.
Ensure that work is carried out safely and in compliance with the organization’s quality system. Ensure that quality documentation is generated and updated to reflect current best practice and that this is done in a timely manner.
Take project lead within new projects drive towards timely and successful completion of these projects while harnessing good communication within the team.
Perform other duties as assigned.

Additional Skills/Knowledge:

Strong hands-on experience in analytical instruments, such as HPLC, dissolution, GC, Karl Fisher, etc.
Working experience with analytical method development and validation on API and finish product
Excellent team and interpersonal skills
Ability to interact successfully with multiple cultures,
Good knowledge of cGMP, ICH and other FDA or international guidance and regulations.
Demonstrate compliance with procedures and policies.
Strong written and verbal communication skills. Bilingual capability (English and Chinese) is a big plus.
Strong attention to detail
Willingness to work flexible hours.

C. ORGANIZATIONAL RELATIONSHIPS:

Report To: Associate Director of RD

D. MINIMUM/PREFERRED REQUIREMENTS:

Education:	BS/MS degree in Chemistry or Pharmaceutics.
Experience:	BS: 8+ years of experience. MS:5+ years of relevant experience is required; Previous record of analytical project lead is plus.

E. PHYSICAL DEMANDS/ENVIRONMENTAL CONDITIONS:

Laboratory and office environment
Ability to perform laboratory function associated with position and required in a research lab
Standing to perform bench tests, bending, climbing, lifting up to 40 lbs., and ability to wear all required safety equipment as work and environment required.

PuraCap Pharmaceutical LLC is an equal opportunity employer and affords equal opportunity to all applicants and employees for all positions without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other status protected under local, state, or federal laws.

If interested in applying for any of the above positions at PuraCap, please send your Resume / CV to humanresources@puracap.com