- 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
- 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.
-
Group Leader
3 weeks ago
American Society Of Gene & Cell Therapy Middleton, United StatesJob Description · At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with th ...
-
Group Leader
2 weeks ago
Thermo Fisher Scientific Middleton, United StatesJob Description · At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with t ...
-
Group Leader
3 weeks ago
Life Technologies Middleton, United StatesJob Description · At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with t ...
-
Group Leader
3 weeks ago
Thermo Fisher Scientific Middleton, United StatesJob Description · At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with t ...
-
Group Leader
2 weeks ago
Life Technologies Middleton, United StatesJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the r ...
-
Civil Engineer Group Leader
1 week ago
Harrison Consulting Solutions Madison, United StatesGrowing Mid-West consulting firm looking to add a Civil EngineerGroup Leader to their growing Madison area office · Responsibilities:Direct/lead group of civil engineering project managers · Manage growth of public/private civil engineering projects · Assist with business develop ...
-
Associate Group Leader
1 week ago
Thermo Fisher Scientific, Inc. Middleton, United StatesSupport QC Routine Release and Stability work/program. Reviews study protocols, project status reports, final study reports and other project-related technical documentation. Reviews, interprets and analyzes data for technical quality and complianc Group Leader, Associate, Leader ...
-
Associate Group Leader
2 weeks ago
Thermo Fisher Scientific, Inc. Middleton, United StatesPerforms lab work in accordance with client protocols, methods and requirements. Prepares study protocols, project status reports, final study reports and other project-related technical documentation. Designs experimental study and participates in Group Leader, Associate, Leader ...
-
Associate Group Leader
2 weeks ago
Thermo Fisher Scientific Inc. Middleton, United StatesJob Description · At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with th ...
-
Associate Group Leader
1 week ago
Thermo Fisher Scientific Inc. Middleton, United StatesJob Description · Job Description · At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide ...
-
Associate Group Leader
1 week ago
Thermo Fisher Scientific Middleton, United StatesJob Description · At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with t ...
-
Associate Group Leader
3 weeks ago
Thermo Fisher Scientific Middleton, United States OTHERJob Description · At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with t ...
-
Associate Group Leader
3 weeks ago
Thermo Fisher Scientific Middleton, United StatesJob Description · At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with t ...
-
Associate Group Leader
1 week ago
Thermo Fisher Scientific Middleton, United StatesJob Description · Job Description · At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provi ...
-
Quality Group Leader
2 weeks ago
TruPath Madison, United States Full timeQuality Group Leader - Metal Manufacturing · We are a well-established and busy, national metal manufacturing organization seeking an experienced Quality Group Leader to join our winning team at our new facility in Huntsville, AL. The ideal candidate will have recent experience i ...
-
Camp Group Leader-Summer
1 week ago
Big Oak Child Care Center Madison, United StatesJob Description · Job Description · Summary · Orton Park Camp is seeking enthusiastic team members for our summer 2024 program from June 10th to August 16th.We are looking for someone who has experience with classroom management for elementary age children. Ideally, this candidat ...
-
Power Utility Infrastructure Group Leader
2 weeks ago
SmithGroup Madison, United StatesSmithGroup is an award-winning, integrated design firm that blends research, data and technology with innovation and a creative spirit to deliver resilient, inclusive spaces that solve our clients' greatest challenges. Our teams create exceptional design solutions for healthcare, ...
-
Central utility plant and group leader
1 week ago
SmithGroup Madison, United StatesSmithGroup is an award-winning, integrated design firm that blends research, data and technology with innovation and a creative spirit to deliver resilient, inclusive spaces that solve our clients' greatest challenges. Our teams create exceptional design solutions for healthcare, ...
-
Engieering Technician
1 week ago
Actalent Madison, United States Full timeSummary · Assemble and test medical device assemblies, final products, and accessories · per the manufacturing documentation provided. Perform assembly diagnosis, · repair with limited supervision. Ensure work is completed in compliance with · company quality system and medical d ...
-
Director Human Resources
3 weeks ago
SSM Health Madison, United States**It's more than a career, it's a calling.** · WI-REMOTE · **Worker Type**: · Regular · **Job Highlights**: · PRIMARY RESPONSIBILITIES · - Partners with business unit leaders to develop and deliver strategic human resource solutions to achieve defined business unit goals. · - Act ...
Senior Group Leader - Middleton, United States - Thermo Fisher Scientific
Description
Job DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
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:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Education and Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years) or equivalent and relevant combination of education, training, & experience.
2+ year of leadership responsibility
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Thermo 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:
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
