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Manager, CMC Analytical Development

Cary, NC 27513

Posted: 02/16/2024 Employment Type: Direct Hire/Perm Job Category: Scientific Job Number: 600064 Is job remote?: No Country: United States

Job Description

POSITION OVERVIEW 
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. 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Cary, NC

Ready to elevate your career? Explore exciting job opportunities in the vibrant area surrounding Cary, North Carolina. Known for its unique blend of southern charm and thriving economy, Cary offers an ideal environment for professional growth and work-life balance. From the serene beauty of William B. Umstead State Park to the cultural richness of the North Carolina Museum of Art, there is no shortage of attractions to explore. Indulge in the region's renowned BBQ joints, catch a performance at the Duke Energy Center for the Performing Arts, or cheer on the Carolina Hurricanes at PNC Arena. Join us in Cary, NC, and discover why this dynamic community is the perfect place to advance your career.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.