Drug Substance Lead

Proclinical is currently recruiting for a Technical Operations for an international pharmaceutical company located in Boston, MA. Successful candidate will be reporting to the Manufacturing Sciences and Analytical Technology Group Lead.

Job Responsibilities:

• Establish/Lead technical oversight at Drug Substance Contract Manufacturing Organizations in accordance with the Company's External Manufacturing organization framework.
• Proactively drive technical deviation investigations, change implementations and continuous improvement activities in alignment with Technical Team and Strategic Operations Team goals.
• Establish/Maintain Drug Substance Upstream and Downstream process monitoring for commercial products as part of robust Continuous Process Verification.
• Lead tech transfers, scale-up, process validation activities.
• Author CMC related sections for regulatory filings such as IND, IMPD, BLA etc.
• Perform process risk assessments to define improvements and mitigate gaps as per Quality and Regulatory requirements and industry best practices.
• Remain updated with latest trends, technologies and best practices in cell culture technologies through professional organizations, peer reviewed literature, trade journals and vendor sources.
• Maintain project specific budget and provide input to department budgets.

Skills and Requirements:

• Minimum BS in Chemical Engineering or Biochemistry with 8-10+ years relevant experience, or a MS or PhD in Biochemistry/Chemical Engineering/Pharmaceutical Sciences with 5-8+ years of relevant experience in up/downstream process development and/or manufacturing of recombinant protein therapeutics.
• Hands-on experience with biologic drug substance development and/or manufacturing using microbial fermentation or mammalian cell culture, with thorough knowledge of upstream and downstream purification.
• Strong understanding of typical analytical methods and working knowledge in microbiology.
• Experience in collaborating with Contract Development/Manufacturing Organizations and external partners.
• Expertise in use/application of variety of problem-solving tools.
• Experience working with single use technology.
• Proficient with basic Project Management skills.
• Expertise in use/application of basic statistical methodologies and softwares.
• Strong ability to strategically plan, organize, and manage multiple projects simultaneously.
• Demonstrated track record of creativity and problem solving in projects.
• Ability to work in interdisciplinary teams with strong interpersonal skills.
• Strong knowledge of relevant GxPs as well as applicable multinational regulatory guidelines.
• Ability to effectively operate in an environment that requires collaboration, influencing skills, negotiation skills, and analytical judgment.
• Excellent written/oral communication and presentation skills.
• Strong analytical skills and attention to detail.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matt Tong at (+1) 646-878-6308 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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