Senior CMC Analytics Lead - Pharma

Veloxis Pharmaceuticals, Inc.

North Carolina

On-site

USD 150,000 - 160,000

Full time

14 days+

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Benefits offered by this job

Health benefits

Insurance

Training & development

Bonus eligibility

Job summary

Asahi Kasei is seeking an experienced analytical leader to provide support for product portfolio testing from development through post-approval. You will collaborate with CRO/CDO/CMOs to ensure CMC testing, method development, validation, and transfers meet regulatory and company requirements.

The role emphasizes delivering high-quality data interpretation, leading lifecycle management of reference materials, and preparing documentation for IND/IMPD/NDA filings, while coordinating timelines with

Qualifications

BS, MS or PhD in Analytical Chemistry, Biochemistry, or related field.
10 years of experience in CMC analytical in pharmaceutical testing environments.
Extensive knowledge of development, validation, and qualification of CMC analytical methods.
Extensive knowledge of CMC analytical techniques (HPLC, ligand binding assays, capillary electrophoresis, CCIT, endotoxin, process impurity methods, peptide mapping, and mass spectrometry).
Demonstrated expertise in troubleshooting and resolving CMC-related laboratory investigations and deviations.
Knowledge of regulatory submission requirements for CMC development, including analytical modules for drug substance and drug product (3.2.S and 3.2.P).
Ability to analyze and transform CMC data (release and stability) into actionable knowledge.
Extensive knowledge of ICH, market-specific guidance, national pharmacopoeia, and industry workgroups.
Demonstrated ability to assess and act on programs of work to meet business goals.
Proficiency in quality procedures (GMPs, including data integrity).
Consistent application of scientific/technical concepts to resolve issues efficiently and effectively.
Efficient time management, capable of multi-tasking and prioritization; structured and proactive work approach.
Excellent interpersonal and communication skills (verbal, written, presentation) to both internal and external audiences.
Proficiency in MS Office Suite (Outlook, Excel, Word, PowerPoint) and Adobe Pro.

Responsibilities

Oversees conduct of all CMC testing (large molecule) at CRO/CDO/CMOs.
Oversees CMC method development, validation, qualification, and transfers at CRO/CDO/CMOs.
Oversees CMC stability programs at CRO/CDO/CMOs.
Provides expert review, assessment, and trending of CMC analytical data from CRO/CDO/CMOs.
Oversees characterization, qualification, and life‑cycle management of reference materials.
Serves as technical lead for CMC analytical testing.
Manages CMC methods and specifications for release and stability.
Communicates project tasks, deliverables, and timelines to external partners, ensuring critical deadlines are met.
Authors relevant documentation to support regulatory filings (IND, IMPD, NDA/BLA, post‑approval changes).
Authors, reviews, and/or approves protocols, SOPs, change controls, and reports, ensuring delivery to Company departments and external vendors.
Supports partners in all activities related to CMC analytical development.
Assists in the department’s efficient execution of departmental/area goals.
Supports the Quality Assurance department in auditing activities of CRO/CDO/CMOs.
Prepares for regulatory agency inspections, including pre‑approval inspections of Company and contractor facilities.
Stays abreast of scientific literature and regulatory guidelines pertinent to CMC analytical development and therapeutic areas.