Responsible for managing all Quality Control aspects (development, quality testing and support to regulatory filings & development of quality systems) of biological and/or small molecule projects in support of US and international drug development programs as well as commercial programs. The Manager, Laboratory Operations will have significant interactions with both internal and external customers, such as: Manufacturing, Validation, Pharmaceutical Development, Regulatory Affairs, Quality Assurance, Human Resources, etc. External customers include CLOs, CMOs and third party logistics groups, etc.
Reviews all batch test release and stability data generated by external testing laboratories as well as analytical test information provided in batch records as part of QC laboratory disposition.
Manages quality related activities at the CLOs including:
• Monitoring the batch release and stability schedules
• Supporting stability protocols – creation and updating
• Reviewing stability data for completeness and against current specifications
• Maintaining the systems to track samples submitted for testing, including the testing of standards/reagents & inventory management
• Providing input to the annual budgeting process for all release, stability and development work
Regulatory Filing Support:
Supports Regulatory submissions with analytical and QC data including assisting with the preparation of the data packages, confirmation of data for submission to source information, and against raw data. Reviews IND submission tables against original raw data for accuracy. Contributes to the preparation of APRs/PQRs.
Contributes to and supports the creation and maintenance of quality systems, especially in relation to analytical methods, specifications, and stability data, along with metrics trending for batch data and CLO/CMO performance. Provide leadership in support of activities related to analytical related quality systems, relative to:
• Change Control
• OOS/OOT investigations
• Clinical and Commercial complaints
• SOPs, etc
Manage all aspects of the day to day activities of 0 - 3 full time staff members and several other indirect reports. Ensure appropriate training and oversight of direct reports to accomplish department and company objectives. Integrate (with direct supervision) and facilitate personal contributions to project teams and interdepartmental activities.
Technical Oversight at CLOs:
Maintain oversight of contract laboratories through onsite visits (boots on the ground).
• Develop hands-on expertise in methodology used to test products.
• Develop hands-on expertise in CLO quality systems, procedures and processes and lead alignment between the company and CLOs.
Education: Requires a B.S. in Chemistry, Biochemistry, Pharmaceutical Science or related field
Experience (e.g. Jobs, supervisory, industry, international, etc…):
5 or more years Quality Control experience with familiarity working in a cGMP environment. Requires at least 5 years analytical development/quality control experience working in the pharmaceutical industry for the development of biological products.
Specialized knowledge, Licenses, etc.:
Very strong working knowledge of the Quality Control activities necessary to manage programs using inside and/or outside personnel at third party sites.
Strong communication skills (both written and oral) are essential. Experience working in a multi-cultural, multi-lingual environment is necessary with a demonstrated ability to contribute successfully in a multi-disciplinary team environment. Ability to work in a fast paced environment and thrive in an environment with ambiguity. Ability to maintain confidentiality in all dealings with staff members.
Working conditions (ability to travel, lifting….etc.):
Office environment with travel to CLOs/CMOs and potential partners for technical discussions and project activities.
Demonstrated experience leading an analytical development and/or a quality control unit both internally and through external contract labs.
Travel expectations Both domestic and international travel required (20 to 50%)