Drug Product Lead

Proclinical is currently recruiting for a Drug Product Lead 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 Product 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
• Collaborate efficiently with Quality, Operations, Supply Chain and extended teams
• Establish/Maintain Drug Product manufacturing 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 BLA, NDA 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 sterile product development and aseptic processes 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 Degree in Pharmaceutical Sciences or Chemical Engineering or related technical field with 8-10+ years relevant experience, or preferably a MS or PhD in Pharmaceutical Sciences or Chemical Engineering with 5-8+ years of relevant experience in sterile drug product formulation and process development and manufacturing including experience with regulatory submissions
• In-depth knowledge of Sterile Drug Product formulation concepts/techniques and aseptic fill/finish processes including lyophilization
• In-depth knowledge of container closure components as well as single-use components and technologies typically used in aseptic processes
• Strong ability to strategically plan, organize, and manage multiple projects simultaneously
• Demonstrated track record of creativity and problem solving in projects
• Strong interpersonal skills and demonstrated accomplishments working in interdisciplinary teams
• Strong knowledge of relevant GxPs as well as applicable multinational regulatory guidelines
• Proficient with basic Project Management skills
• 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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