Senior Group Leader - Cell Bioassay
Pharmaceutical Product Development (PPD)
Middleton, Wisconsin, United States of America
Job Description
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
As a Senior Group Leader, provide line-level management coordination of resources and work schedules for laboratory activities.
Summarized Purpose:
Provides oversight and supervision of staff and resources performing pharmaceutical development studies such as method development and validation, stability, QC, etc. Manages the work activities of group and associate group leaders, resource planning and allocation, client communication, technical document generation and review, mentoring technical staff and troubleshooting method and product-related issues. Ensures the compliance of work performed within the laboratory as well as working with manager to meet the financial goals of the organization.
Essential Functions:
Reviews and approves study protocols, project status reports, final study reports and other project related technical documents. Designs experimental studies and participates in technical troubleshooting.
- Allocates, schedules and manages laboratory resources for group's project activities and updates project status and revenue projections. Reviews timesheet reports for billing accuracy.
- Reviews data for technical quality and compliance to protocols, methods and SOPs. Approves laboratory investigations, deviations, QA facility and data audits. Leads client and FDA audits.
- Responds to clients questions and needs; leads client technical meetings. Provides recommendations to clients on analytical and compliance issues.
- Prepares and approves proposals, project definition and pricing. Participates in project definition and negotiations with client on timelines and budget.
- Identifies business opportunities at conferences, workshops, within the community, through client interaction, etc. Participates in technical sales and marketing; prepares technical marketing materials. Works with business development as technical representative for client visits/discussions.
- Prepares and implements PPD SOPs and company operational policies. Ensures adherence and makes recommendations to quality system improvements.
- Accountable for group's knowledge and application of good practices pertaining to GMP/GLP and / or other laboratory / client requirements.
- Participates in bi-annual SOP review & change. Ownership of changes needed to comply with SOPs.
- Regularly communicates to staff quality related issues and items for staff development and implements quality improvements.
- Demonstrated proficiency on technical operating systems
- Experience in biosafety, biologics safety testing, mycoplasma and viral safety, viral clearance, and adventitious agent
- Background in transmission electron microscopy (TEM) including operation and execution of TEM protocols
- Previous experience with testing of cell banks and production cell cultures on the presence of retroviral particles is a plus
- Proven leadership skills
- Ability to train and mentor junior staff
- Demonstrated ability to be project solution driven
- Good written and oral communication skills as well as presentation skills
- Can independently perform root cause analysis for method investigations
- Technical writing skills; ability to write quality documents (SOPs, investigation forms, etc.)
- Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs
- Ability to independently optimize analytical methods
- Project and time management skills
Work EnvironmentThermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary and/or standing for typical working hours.
- Able to lift and move objects up to 25 pounds.
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology with proficiency.
- May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!
Job posted: 2024-03-21
