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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Director/AD - Analytical Development & Quality Control
Posted: 01/17/2024
2024-01-17
2024-03-27
Employment Type:
Direct Hire
Job Category: GMP/cGMP
Job Number: 3691
Job Description
Our client is seeking a dynamic and experienced leader to join their team as the Leader of Analytical Development and Quality Control. In this role, you will be responsible for overseeing and driving the analytical development and quality control functions within our client's organization. You will play a crucial role in ensuring the quality, safety, and efficacy of pharmaceutical products while supporting the development of innovative drugs.
Key Responsibilities:
Leading a team of 2+ Analytical Scientists, 3+ QC Scientists, and a number of external partners performing analytical development activities for the testing and characterization of peptides, recombinant proteins, and nanoparticle based parenteral drug products utilizing HPLC, LC-MS, Capillary Electrophoresis, Peptide Mapping, ELISA, gel electrophoresis and a number of other characterization techniques.
Qualifications:
Key Responsibilities:
Leading a team of 2+ Analytical Scientists, 3+ QC Scientists, and a number of external partners performing analytical development activities for the testing and characterization of peptides, recombinant proteins, and nanoparticle based parenteral drug products utilizing HPLC, LC-MS, Capillary Electrophoresis, Peptide Mapping, ELISA, gel electrophoresis and a number of other characterization techniques.
- Leading development and qualification of analytical methods within cGMP compliance.
- Designing and conducting stability, impurity, and degradation studies.
- Leading analytical related process characterization studies.
- Contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions.
- Providing technical leadership and subject matter expertise relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes.
- Working cross functionally with Process Development, Manufacturing, MSAT, Regulatory, and Quality Assurance departments.
Qualifications:
- BS+ Degree
- 3 years of experience in leadership/managing a department/team and external partners
- Recombinant Protein Analytical expertise
- Parenteral Drug Product Analytical expertise
- Experience leading teams from Development to Commercialization
- Expertise working with HPLC, LC-MS, Capillary Electrophoresis, Peptide Mapping, ELISA, gel electrophoresis, nanoparticle characterization, microbial methods.
- Experience contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions desired.
- Experience working on method transfer and validation activities within cGMP compliance.
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