What are the responsibilities and job description for the MDAS Group Leader position at 40North?
SUMMARY OF POSITION
The Method Development and Analytical Services (MDAS) Group Leader leads and participates in the activities supporting the laboratory function in executing daily operations of the analytical research and development, analytical validation and testing necessary to support commercialization of pharmaceutical products. The MDAS Group Leader serves as direct supervision of focused laboratory staff as well as an expert, hands-on resource for the execution of laboratory work.
ORGANIZATION STRUCTURE
The MDAS Group Leader reports to the MDAS Manager or the MDAS Director. Direct reports to this position may include: Laboratory Assistant, Research Assistant, Research Associate or other lower level positions within MDAS.
RESPONSIBILITIES
- Responsible for leading and supervising the activities of a focused group of MDAS staff providing analytical support of product development.
- Provides expert-level, hands-on laboratory benchwork, data evaluation, and data management to support product development.
- Provides adequate supervision to group members to ensure accurate, error-free execution of assigned tasks.
- Schedules and delegates work to efficiently meet project needs and deliver within timelines.
- Responsible for the development and execution of the method validation strategy for analytical methods necessary for commercialization of pharmaceutical products. This may include evaluating and defining material specifications, validation/verification/transfer requirements, equipment acquisition/installation, reference standards/reagents authoring methods/reports and other steps as required.
- Serve as a technical resource for the group, ensuring the application of technical knowledge and problem-solving approaches.
- Provides training of personnel according to role and job function to ensure the group can meet its mission and responsibilities.
- Ensures group awareness and use of up-to-date technical information such as procedures, specifications, compendia and guidance.
- Identify exceptional conditions and non-conformance and conduct investigations to determine root cause, assess business impact, and develop actions to assure reconciliation and eliminate repeat occurrence.
- Represent the MDAS function in meetings, providing status updates, participating in the project discussions and confirming commitments for deliverables.
- Makes safety a cultural norm by role modeling safety behaviors for the group and providing corrective feedback for outages.
- Provide support to Agency Inspections and quality audits.
- Maintains all responsibilities of the MDAS Senior Research Associate.
QUALIFICATIONS
- BS plus 10 years progressively responsible experience, including leadership roles in pharmaceutical analytical laboratories or equivalent education and experience.
- Expertise in cGMP concepts, ICH guidelines, and industry standards.
- Strong analytical aptitude, ability to comprehend and apply scientific theory and analytical techniques to solve problems.
- Advanced computer skills specifically in Microsoft Office and ability to master new applications quickly.
- Refined written and verbal communications and presentation skills.
- Ability to manage personnel and drive assigned projects to an on-time delivery.
- Strong organizational skills, ability to manage and complete assigned projects on time.
GMP DECISION-MAKING AUTHORITY
The MDAS Group Leader has authority to perform, supervise, and manage work as assigned supporting method development, validation, sample testing and other requirements associated with the development of manufacturing processes supporting commercialization of pharmaceutical products.
“An Equal Opportunity Employer, including disability/vets.” /
