Analytical Development Chemist, 1st Shift

*Schwarz Pharma-UCB Group is a multinational pharmaceutical company.  We strive to serve unmet medical needs by developing and marketing innovative products for specialty markets.  We are committed to providing excellent services to our customers and creating significant value for our investors.* 

 

We are currently recruiting for a 1st Shift Analytical Development Chemist.  This position is primarily responsible for developing, validating, transferring and writing analytical methods for raw materials and drug products.  This position is also responsible for the timely and accurate analysis of formulation and pre-formulation samples from the Pharmaceutical Technology and laboratory guidelines.

 

Essential Functions:

· Analytical method development and validation.

· Analytical method transfer with QC and with external customers.

· Write validation and transfer protocols.

· Write analytical methods.

· Provide well-written, accurate and timely reports.

· Validate Excel spreadsheets.

· Train others on validated methods.

· Perform accurate and timely analysis of Pre-Approval and Post-Approval stability samples.

· Perform all work using appropriate safety measures and follow the Chemical Hygiene Plan.

· Document all laboratory testing and maintain accurate and legible notebooks and records.

· Peer review of data, reports and notebooks.

· Assist in maintaining laboratory equipment and facilities.

 

Training or Experience:

· Knowledge of cGMP, USP and FDA Guidelines.

· Experience with ANDA submissions helpful.

· Excellent oral and written communication skills.

· Able to troubleshoot analytical methods and laboratory instrumentation.

· Working knowledge of Microsoft Work and Excel.

· Experience with Chromatography Data Acquisition systems.

· Demonstrated ability to work as part of a cross-functional team.

 

Education:

· Degree in Chemistry or related field.  Relevant experience may be substituted in lieu of degree.

 

Supervises/Manages:

· None

 

We offer excellent, competitive benefits – Health, Dental, Vision & Life Insurance, 401k, Tuition Reimbursement, Employee Referral Program, Bonus System, Flex Time, Profit Sharing, etc.

 

Schwarz Pharma-UCB Group is an equal opportunity employer committed to a drug free workplace.