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CMC Technical / Analytical Support Specialist


Location: Bridgewater, New Jersey
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CMC Technical / Analytical Support Specialist

Job Description
The role of this technical position serves as an in-house Analytical Expert related to CMC issues. This position will work with supervisor to coordinate and support analytical project needs that are conducted at internal analytical labs and external contract analytical laboratories.

Key Duties and Responsibilities
• Coordination of laboratory supplies and samples, ensuring sample delivery and work initiation at the third party labs. Monitoring of the activities with close contact with Industrial Analytical management for follow-up.
• Technical work also includes review of documentation, study initiation, follow-ups, data review and summary, and drafting of short reports with guidance. Will perform data trend analysis and provide summary to managers. Additional responsibilities include involvement with labs to follow up on studies. Occasional visits to contract labs are required.
• Maintain physical and electronic reference standard inventory and ordering of some specialty laboratory supplies for the contract labs. Perform electronic orderings of supplies and set up analytical studies. Other support services could also be assigned to the incumbent including, technical documentation filing, and receiving / shipping of packages of drug substance and drug product, etc.
• Plan and coordinate all the analytical activities with external CRO Laboratories, CMO manufacturing sites 
• Prepare analytical testing protocols and budget plans for the analytical activities requested by various client internal and external sites.
• Support development plans of new products, product line extensions and manufacturing site technical transfers of the client's commercial products. This includes review and input for analytical method development, analytical method validation, associated reports and required stability studies in compliance with ICH/ FDA guidelines.
• Provide guidance and review of CMC analytical responses prepared by the Industrial Development team members requested by the regulatory agencies.
• Attend and participates in the ongoing CRO/CMO manufacturing sites planning and progress meetings. May require occasional travel to local contract lab.

Skills
A successful candidate for this position must have good organization skills and good communication skills. Understanding of basic analytical techniques is essential, e.g. HPLC, UV, GC, Mass spec, dissolution, etc. Experience with analytical method development, validation activities as well as analytical project coordination and management is required. Specific oversight of third party contract laboratories is a plus.

Basic requirements
MS degree in Chemistry, or related scientific fields with 3-6+ years of experience or BS degree with 6-10 years of experience. Good application of math and other suitable scientific courses relating to testing and stability data monitoring. Knowledge of laboratory cGMP and hands on application of Word, Excel, and Power point are necessary.

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