QC Laboratory Lead

The Philadelphia, PA manufacturing site is the home of FluMist, the world's only nasally administered influenza vaccine. The site consists of two geographic locations - a facility at Red Lion Road in NE Philadelphia has about 135 full-time employees and the Bensalem storage and distribution facility has about 6 employees. Our influenza vaccine is aseptically filled and packaged at the Red Lion Road location and is stored for final distribution at the Bensalem location. The facilities are about 8 miles apart and both are situated close to I-95, the city of Philadelphia, and Philadelphia International Airport. Our product is sold in multiple countries, including the US and UK. Operations continue year-round, with the FluMist production campaign running in the summer (typically April-August). Our site is highly collaborative, and we show our Philly pride in all we do. We work closely together, always striving to be better every day. We have a network of employee teams who deliver various employee engagement activities. From our famous Wingbowl, to inclusion events, site celebrations, community outreach, and health and wellness activities, there's something for everyone. Accountabilities for: Manager - Responsible for leading staff to ensure that the day-to-day activities and Microbiology laboratory operations run efficiently. - Ensure all testing meets cGMP standards required by regulatory agencies. - Provide leadership and direction for safety (SHE) initiatives in agreement with site and company goals and standards. - Lead all testing of utilities and environmental monitoring, raw materials, in process and finished product. - Ensure laboratory equipment is calibrated and maintained adequately. - Ensure that training and analyst qualifications are up to date. - Review standard operating procedures, validation protocols and reports. - Coordinate microbiological assay qualification and validation. - Assist, if required, in validation of facility, systems, and manufacturing processes. - Guide the process to ensure the databases are established and maintained, and that trend analysis of the water purification system, environmental monitoring and microbial data is completed in a timely manner. - Resolve out-of-specification results - work to resolve issues with OOS investigations. - Interact with Corporate Microbiology, Manufacturing, QA, and Regulatory Affairs to forward appropriate information and regulatory agency updates. - Participate and assist in inspection by regulatory agencies and internal and external audits. - Work with training to develop analyst qualification for performance of assays. - Frequent contacts with equivalent level managers and customer representatives concerning projects, operational decisions, scheduling requirements, or contractual clarifications. Conducts briefings and technical meetings for internal and external representatives. - Provide tactical direction and vision for ongoing and new projects in accordance with PET and QC goals. Sr. Manager Performs duties of Manager, plus the following: - Greenlight change controls, CAPAs and OOS and Non-conformance investigations. - Review and approval of product release CoAs. - Subject to approval, modifies the organizational structure of centralized functions and units. Minimum Skills/Experience - Requires a Bachelor's Degree in Microbiology, Biological Sciences or related field, Plus: Manager: - 6+ years of experience in biopharma, medical device, or pharmaceutical manufacturing. - 2+ years supervisory experience. - Ability working in a matrix environment. - Excellent communication skills (with staff, peers and upper management) and ability to develop rapport with other functional leaders to influence decision-making. - Accomplishes results through subordinates. - Ability to interpret and analyze statistical data and information and financial reports, understand and resolve technical difficulties, collaborate with internal engineering/technical experts and external technical representatives, and prioritize in a manufacturing plant setting. Senior Manager: - 8+ years of experience in biopharma, medical device, or pharmaceutical manufacturing. - 4+ years supervisory experience. - All skills listed under Manager and those listed below: - Seeks accountability for complex projects and independently drives them to completion through management of staff. - Work is performed without appreciable direction. Supports organizational objectives, and interprets company policies. Interprets and implements policies and procedures that typically affect subordinate organizational units. Recommends modifications to operating policies. - Detailed understanding of cGMP standards established by regulatory agencies, such as USP, EP, FDA, and ISO. - Ability to set up and change intricate systems in the QC department consistent with company policy that apply the concepts of lean, six sigma, 6S and others. Desirable Skills/Experience - Advanced Degree Desired, Plus Manager: - 3+ years of experience in aseptic operations. Senior Manager: - 3+ years of experience in aseptic operations. - 1+ years of supervisory experience in aseptic operations. - Detailed understanding of electronic data integrity principles. When we put unexpected teams in the same room, we ignite pioneering thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, completely onsite, but that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and daring world. Experience the energy of launching new products while adapting at pace. Our resilience helps us develop as we innovate continuously. We foster a safe space where ideas are welcomed, promoting discussion to focus on what's important"”delivering life-changing medicines to patients. Ready to make a big impact? Apply now! Date Posted 29-Oct-2024 Closing Date 14-Nov-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

Created: 2024-10-31