Careers

The Sr. Regulatory CMC Associate will play a lead role in driving the CMC portion of regulatory filings including coordination, review and timely generation of submission ready documents. This position is based in Cambridge and reports to the Director of Regulatory and Clinical Operations.

Responsibilities include:

• Play the lead role in managing post-approval changes, including change management across products, and coordinating all CMC aspects of regulatory submissions
• Ensure all CMC dossier data remain relevant, compliant, and an accurate reflection of all processes and practices.
• Ensure the content and format of regulatory CMC submissions comply with applicable regulations and guidelines.
• Identify and assess regulatory risks for specific projects.
• Participate in the design, development and implementation of department improvement initiatives.
• Research, review and interpret the regulatory environment surrounding related to product approvals, current guidance documents to support the development of optimal regulatory strategies that support successful submissions.
• Coordinate cross functional department requirements to ensure regulatory timelines and milestones are met.

Job requirements:

• BA/BS in a scientific discipline.
• 6+ years hands on regulatory CMC experience, (biologics preferred) or 3 years pharmaceutical manufacturing, QC, and/or QA, with 3 years regulatory CMC.
• Experience in the preparation of CMC regulatory documents for major submissions (CTD, BLA, MAA, supplements, variations, responses)
• Thorough knowledge of US & EU regulatory requirements pertaining to the manufacture of pharmaceutical and sterile biological APIs and drug products.
• Must be able to write and verbally communicate information in a clear and concise manner.
• Excellent interpersonal skills and an ability to represent the Company to outside parties as required.
• Strong organizational skills, including the ability to prioritize workload, and an ability to work in a high pressure environment.
• Effective cross functional and cross cultural skills.
• Intermediate / advanced Microsoft Office

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QC Supervisor 1st and 3rd shifts

The QC Supervisor oversees development and implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products. Oversees and coordinates shift activities of the QC Lab.

Responsibilities include:

• Maintains QC analytical function in GMP compliance and regulatory inspection ready.
• Supervises all aspects of testing in support of first shift manufacturing operations and facility environmental monitoring.
• Ensure that all testing is conducted in accordance established test methods and/or USP or Ph Eur.
• Participates in validation of equipment and analytical assays.
• Assists in the conduct of laboratory investigations.
• Conducts periodic reviews of standard operating procedures for adequacy and compliance with current versions of compendia.
• Hosts internal audits of QC labs.
• Ensures maintenance of analytical equipment maintenance and calibration logs

Job requirements:

• This job requires a bachelors or masters degree in a scientific field.
• 3 – 4 years experience in Quality Control.
• Working knowledge of standard analytical methods and equipment.
• Excellent interpersonal skills and good oral and written communication skills
• Broad knowledge of analytical procedures common in the biotech community.
• Some experience in Quality Assurance is a plus
• Proficient in MSOffice and standard QC data bases

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Quality Control Manager

 Manufacturing Technician