Manager/Sr. Manager, CMC Analytical Development
1001 Winstead Dr, Ste 310 Cary, NC 27513 US
The incumbent in this position provides analytical support of the Company’s product portfolio and pipeline from early-stage development through post-approval requirements and works directly with the Company’s partners to ensure testing is compliant with Quality, Regulatory, and Company requirements, necessitating a high level of external communication and interaction as well as ability to manage multiple projects. The incumbent works on project teams to drive the growth and development the Company’s products, as well as with contract research/development/manufacturing organization (CRO/CDO/CMO) partners on study activities to meet established timelines and provide necessary scientific oversight for outsourced work on method development/re-development, qualification/validation, sample analysis, characterization, data delivery, and reporting.
SUMMARY OF KEY RESPONSIBILITIES
- Oversees conduct of all CMC testing (large molecule) at CRO/CDO/CMOs.
- Oversees CMC method (large molecule) 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.
- Efficiently communicates project tasks, deliverables, and timelines to external partners, ensuring that critical deadlines are agreed upon and met.
- Authors appropriate documentation in a timely manner to support regulatory filings, including but not limited to IND, IMPD, NDA/BLA, and pre- and post-approval changes.
- Authors, reviews, and/or approves all technical related protocols, SOPs, change controls, and reports, as needed, ensuring delivery of those reports to other Company departments (Manufacturing & Technical Operations, Clinical, Quality Assurance, Regulatory Affairs), external vendors, and/or license partners.
- Supports partners in all activities related to CMC analytical development.
- Assists in the department’s successful and 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 at the Company’s facilities and key contractors’ facilities.
- Stays abreast of scientific literature and regulatory guidelines pertinent to CMC analytical development and the therapeutic area(s) of the Company’s products.
REQUIRED QUALIFICATIONS AND SKILLS
- BS, MS or PhD in Analytical Chemistry, Biochemistry, or related field.
- 5-10 years’ experience in CMC analytical in pharmaceutical testing environments (large molecule).
- Extensive knowledge of development validation of CMC analytical methods (large molecule).
- Extensive knowledge of CMC analytical techniques (large molecule: HPLC, ligand binding assays, capillary electrophoresis, CCIT, endotoxin, process impurity methods, peptide mapping, and mass spectrometry).
- Demonstrated expertise in troubleshooting and resolution of CM related laboratory investigations and deviations.
- Knowledge of requirements and strategy for regulatory submissions (BLA) related to CMC development; this includes all analytical CTD modules for drug substance and drug product (3.2.S and 3.2.P).
- Demonstrated ability to analyze and transform CMC data (release and stability) into knowledge.
- Extensive knowledge of ICH, market specific guidance, national pharmacopoeia, and industry workgroups related to CMC analytical development.
- Demonstrated ability to assess and act on programs of work to meet business goals.
- Proficiency in Quality procedures (e.g., GMPs, including data integrity).
- Demonstrated consistency in applying and furthering scientific/technical concepts and techniques to resolve scientific/technical issues efficiently and effectively.
- Efficient time management, capable of multi-tasking and prioritization; structured and proactive work approach.
- Excellent interpersonal and communication (verbal and written); effective presentation skills to both internal and external audiences.
- Proficiency in MS Office Suite (Outlook, Excel, Word, PowerPoint) and Adobe Pro.
- Travel Requirements: Approximately 30%
Salary Range: $100-$150k. Salary will be commensurate with experience.
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