Scientist I – Product Development (R-PDSI)
Scientist I – Product Development (R-PDSI)
Location: Rochester, Michigan
Description:
- In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.
- Performs method development and validation for analytical procedures.
- Prepares and executes product development protocols.
- Participates, examines and solves technical problems associated with development of new generic products by using analytical instrumentation, and classical wet chemical tests.
- Identifies and implements improvements in analytical testing methods.
- Provides training of analytical methods and new technologies.
- Performs all activities following company policies.
- Performs analytical method development for drug substance, drug product or any relevant material per FDA, ICH, and USP/NF and other applicable pharmacopoeias and/or guidelines.
- Applies fundamental knowledge of Analytical Chemistry and advanced technologies in analysis, interpretation and understanding of the test results, for both qualitative and quantitative analyses.
- Following company and departmental policies and guidelines works with the Sr. Scientist to new products.
- Participates in the planning and execution of product, process, cleaning and instrument validation studies; new raw materials, new components, vendor qualification and technical transfers.
- Writes technical reports for new test method, method development, validation, and method transfer. Writes, edits and revises analytical procedures
- Provides expertise and assists in writing development protocols and reports
- Performs routine maintenance, calibration, and performance verification on applicable instruments. Participates in new instrument validation.
- Performs routine and non-routine testing, as required following applicable guidelines and company policies.
- Assists in training of laboratory staff.
- The employee may need to be trained in handling controlled substances. Establishes and maintains effective cross functional relationships.
Education / Experience:
- Bachelor’s Degree in Chemistry or related science field with at least 4 years of analytical chemical laboratory or product development experience.
- Pharmaceutical laboratory experience in analytical methods development and validation area will be extremely helpful.
- Equivalent combination of education and experience or training is acceptable.
If you possess the required background and are interested in being a member of this growing company, submit your resume and cover letter by mail or apply online:
By Mail MCP Pharmaceuticals LLC HR Department, Job Code SAS 870 Parkdale Road Rochester, Michigan 48307
Apply Online To apply for this position, please Apply Online
About MCP Pharmaceuticals, LLC:
MCP Pharmaceuticals is an integrated specialty healthcare company that specializes in sterile injectable products. MCP manufactures and sells brand aseptic injectable pharmaceuticals in hospital and clinical settings and provides contract manufacturing services for global pharmaceutical companies.
MCP’s own product portfolio includes leading diagnostic, women’s health and anesthesia products. All products have a long track record of “gold standard” service and are at or near the front line of treatment in their therapeutic indications. Contract manufactured products include some of the leading global biologic products which involve liquid, lyophilized and suspension presentations.
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