Senior Manager, CMC Quality Control at GSK in Waltham, MA
We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody molecules that are selected and engineered for rapid development so that, together with our therapy area partners, we discover, develop and manufacture novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting edge drug development and discovery organization and are motivated to contribute towards bringing lifesaving drugs to patients, join us! Click to know more about GSK Biopharm. #GSKBiopharm_Development The Sr. Manager, CMC Quality Control is responsible for leading the Quality Control function at GSK in support of CMC development activities and providing guidance to the Quality Control staff. The Sr. Manager will oversee operations pertaining to QC testing at contract testing laboratories and contract drug substance and drug product manufacturing sites. This responsibility includes vendor oversight, project management, data review, and exceptions management. The individual will interact with internal multidisciplinary teams to ensure successful delivery schedules of analytical test reports or certificates. This position includes assisting with QC checks and preparation of regulatory filings (INDs and NDAs). This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Development and implement cGMP compliant procedures crucial to the successful operation of the Quality Control function. Provide both technical and operational chemistry expertise for training, product investigations, deviations, CAPA, quality and operational improvements, etc. to ensure continued compliance with regulations. Provide leadership and direction to development project teams to ensure product quality guidelines are consistently met. Manages and develops the performance of direct reports by setting clear expectations, as well as resolving conflicts. Manage drug substance and drug product analytical testing at contract laboratories including investigation and resolution of analytical test failures (OOS and atypical results) Review QC raw data and assist in batch release. Monitor contract laboratory activities to ensure compliance and timeliness of certificates of approval and reports Assemble data packages in support of specification and method changes associated with GSK products Represent QC in cross-functional teams with internal and external customers Contributes to appropriate sections of IND/IMPD and NDA/BLA/MAA filings, and approves various quality documents (internal and external) associated with GSK products Participate in vendor and internal audits as needed Contribute to company quality systems Why you? Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BS or MS in Biochemistry, Chemistry, or related field with 8
years of industry experience, including management experience in analytical testing laboratory (including in a commerical environment) Experience working with CMOs Experience with analytical testing concepts and current cGMPs including laboratory controls and good documentation practices Experience managing and directing team of Quality Control managers Experience with managing projects and working with cross-functional teams comprised of internal and/or external contacts Ability to travel (includes international), 10% Preferred
Qualifications:
If you have the following characteristics, it would be a plus:
PhD in Biochemistry, Chemistry or related field Working knowledge ICH quality guidance, EU and FDA drug manufacturing regulations Excellent written and oral communication skills. Competency in MS Office Products and Adobe Acrobat Independently motivated and detail oriented with good problem-solving ability. Ability to work a flexible work schedule to accommodate program priorities and international activities as needed
Salary Range:
$100K -- $150K
Minimum Qualification
Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Development and implement cGMP compliant procedures crucial to the successful operation of the Quality Control function. Provide both technical and operational chemistry expertise for training, product investigations, deviations, CAPA, quality and operational improvements, etc. to ensure continued compliance with regulations. Provide leadership and direction to development project teams to ensure product quality guidelines are consistently met. Manages and develops the performance of direct reports by setting clear expectations, as well as resolving conflicts. Manage drug substance and drug product analytical testing at contract laboratories including investigation and resolution of analytical test failures (OOS and atypical results) Review QC raw data and assist in batch release. Monitor contract laboratory activities to ensure compliance and timeliness of certificates of approval and reports Assemble data packages in support of specification and method changes associated with GSK products Represent QC in cross-functional teams with internal and external customers Contributes to appropriate sections of IND/IMPD and NDA/BLA/MAA filings, and approves various quality documents (internal and external) associated with GSK products Participate in vendor and internal audits as needed Contribute to company quality systems Why you? Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BS or MS in Biochemistry, Chemistry, or related field with 8
years of industry experience, including management experience in analytical testing laboratory (including in a commerical environment) Experience working with CMOs Experience with analytical testing concepts and current cGMPs including laboratory controls and good documentation practices Experience managing and directing team of Quality Control managers Experience with managing projects and working with cross-functional teams comprised of internal and/or external contacts Ability to travel (includes international), 10% Preferred
Qualifications:
If you have the following characteristics, it would be a plus:
PhD in Biochemistry, Chemistry or related field Working knowledge ICH quality guidance, EU and FDA drug manufacturing regulations Excellent written and oral communication skills. Competency in MS Office Products and Adobe Acrobat Independently motivated and detail oriented with good problem-solving ability. Ability to work a flexible work schedule to accommodate program priorities and international activities as needed
Salary Range:
$100K -- $150K
Minimum Qualification
Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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