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Position:
Senior Scientist - Quality Control - HPLC - Dissolution - Method Validation

Employer:
PPD, Inc.

Description:

EXPECT MORE FROM YOUR CAREER
EXPECT PPD


PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health. 

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD. 

As a Senior Scientist you will partner with cross-functional teams to continue building a Quality Control organization with primary focus on compliance and efficiency, in order to provide first-in-class service to external and internal customers. This candidate with manage critical, commercial laboratory systems and be compliance subject matter expert in a growing organization. 

Additional responsibilities for the role on site at a major pharmaceutical company: 

  • Partner with Corporate Compliance, Quality Assurance, Global Information Services, and Operations-Facilities in execution of QC functions

  • Review of technical and compliant cGMP analytical data

  • Writing technical methods and reports

  • Analysis of cGMP samples utilizing various analytical techniques-HPLC, dissolution, GC, KF, etc., including method validation, method transfer, and stability

  • Review of cGMP equipment and software qualifications and repair

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.


Join PPD in our relentless pursuit of excellence - apply now!



Qualifications/Experience:

Education and Experience:

  • Bachelor's degree/Master's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or equivalent and relevant formal academic / vocational qualification

  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’) or equivalent combination of education, training, & experience. OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2+ year) 
    OR

  • PhD (preference to those with 1+ year of industry experience)

Knowledge, Skills and Abilities:

  • Demonstrated knowledge of multiple analytical techniques in a QC/commercial setting such as: HPLC, GC, MS, Dissolution Testing, Karl Fischer, UV-Vis, FT-IR

  • Demonstrated knowledge with both drug substance and drug product (oral solid dosage forms) testing

  • Proficient with electronic notebooks and computerized Quality Management Systems

  • Knowledge of Empower Software and Statistical software (JMP, Matlab, Minitab)

  • Proficient in Microsoft Excel and Word

  • Proven ability to interpret data by performing trend analysis

  • Proven ability in technical writing skills

  • Ability to independently optimize analytical methods

  • Proven problem solving and troubleshooting abilities

  • Good written and oral communication skills

  • Time management and project management skills

  • Ability to work in a collaborative work environment with a team

Working Conditions

  • Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment

  • Exposure to biological fluids with potential exposure to infectious organisms.

  • Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.

  • Personal protective equipment required such as protective eyewear, garments and gloves. 

  • Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements

  •  Ability to work in an upright and /or stationary position for 6-8 hours per day.  

  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.  

  • Occasional mobility needed.

  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.    

  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

  • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

  • Frequently interacts with others to obtain or relate information to diverse groups.  

  • Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.  Requires multiple periods of intense concentration.

  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.  Ability to perform under stress.  Ability to multi-task.  

  • Regular and consistent attendance.

 



Location: Boston, MA

Contact: Nicki Woodsmall at nicki.woodsmall@ppdi.com or https://ppdi.referrals.selectminds.com/jobs/senior-scientist-quality-control-hplc-dissolution-method-validation-1458

Post Date: 5/17/2019 12:00:00 AM
┬ęPharmaceutical & BioScience Society, International; Last Modified: 12/10/2019; Admin Logon
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