Remote: Associate Director Analytical Chemistry (232154)

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Job Description:

Vendor management for analytical related activities for drug substance and drug product

• Oversees analytical method development, validation, and transfer activities by vendors

• Reviews method validation protocol, report, and as well as validation raw data

• Reviews release test data and generate CoA

Stability Coordinator for Drug Substance and Drug Product:

• Reviews stability data

• Generates stability result tables

• Files stability data and results tables

• Monitors stability due dates and coordinate data transfer from vendors

Reference Standard Coordinator:

• Oversee qualification, inventory and supply of standards and markers analytical support

• Files analytical methods, validation protocols, reports and any analytical related files

• Reviews analytical data and results to support analytical method transfer/validation at vendors

Shipping Coordinator:

• Coordinates and executes domestic and international CMC shipments

SharePoint filing:

• Support the CMC Team in the filing of documents

CMC/Regulatory:

• Drafts and reviews stability and analytical sections of IMPD/IND/NDA or related regulatory dossiers to support clinical programs

 

Skills & Experience:

• 7+ years of experience in analytical testing in biotech/pharma

• In depth knowledge of HPLC/UPLC, GC, KF, and other analytical techniques

• Hands on experience in carrying out stability studies for drug substance and drug product in QC environment

• Greater than 2+ years managing DS/DP stability, knowledge of ICH stability guidelines

• Detailed knowledge and understanding of current Good Manufacturing Practices (CGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems

• Knowledge of compendial (USP, EP, JP, etc.) requirements and standards for QC testing

• Ability to work independently as well as cross-functionally with teams across the organization

• Ability to effectively handle multiple projects simultaneously in a deadline driven environment

• Strong organizational skills and attention to detail

• Strong interpersonal and communication skills to collaborate effectively with internal and external business partners

 

Plus:

B.S in Chemistry or related field, M.S is preferred. Early Stage Bio

Remote: Associate Director Analytical Chemistry (232154)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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