11 days old

Analytical Services Scientist

Sebela Pharmaceuticals Inc.
Holbrook, MA 02343
































 


Job Description


 


 


 


 


 


Job Title:


Analytical Services Scientist


Department:


QAQC


Reports to:


VP of QC


FSLA Status:


Exempt


 


 


 


 



SUMMARY


Laboratory Bench Position for Routine/Non-Routine Testing and development/validation of new product testing.


 


PRINCIPAL DUTIES AND RESPONSIBILITIES



  • Develop/Optimize/Validate analytical test methods and write protocols/technical reports/test methods in a cGMP environment to support R&D product pipeline requirements

  • Evaluation of contract laboratory test method validation reports for completeness and adherence to cGMP/USP standards




  • Perform non-routine evaluation and testing related to investigations and technology

  • Perform routine laboratory testing

  • Review analytical data for completeness, accuracy, and compliance

  • Provide training regarding test methods, equipment, and compliance

  • Other laboratory duties as assigned



QUALIFICATIONS


 


To perform this job successfully, an individual must be able to perform each essential function satisfactorily, be flexible in terms of work hours, and have strong knowledge and experience in analytical chemistry, compendial references, and cGMP. The requirements listed below are representative of the knowledge, skills and/or abilities required. 



  • Minimum B.S., M.S. preferred in Chemistry or closely related discipline.

  • Minimum 1-4 years experience in a cGMP laboratory (pharma preferred). Minimum 1 year experience in performing method development and validation activities. Minimum 0 years experience, if PhD.

  • Requires experience in a laboratory with instrumental methods such as chromatography and spectroscopy, and strong knowledge of USP analytical techniques.

  • Proven ability to multi-task projects and dedication to meet deadlines.

  • Ability to work in a team environment

  • Requires excellent English written and verbal communication skills, including technical writing skills.

  • Proficiency in Microsoft Office.

  • 5-10% travel may be required.



WORK ENVIRONMENT


 


The work environment described here are representative of those an employee encounters while performing the essential function of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position will be in an office and laboratory environment.


 


PHYSICAL REQUIREMENTS


 


The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this Job, the employee is regularly required to sit for extended periods of time. The employee is occasionally required to stand, walk, stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

Categories

Posted: 2020-10-09 Expires: 2020-11-08

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Analytical Services Scientist

Sebela Pharmaceuticals Inc.
Holbrook, MA 02343

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