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 polic