Sr. Manager/manager, Analytical Services

Sr. Manager/Manager, Analytical Services

The Sr. Manager/Manager, Analytical Services is a leadership position in the Analytical Sciences team, focused on leading a team of Scientists, Research Associates and Analysts who provide GxP, Non-GxP, & Method Establishment attribute phase appropriate testing support for internal and external programs. The Senior Manager/Manager is also accountable for maintaining an inspection ready laboratory.

Key Responsibilities:

• Department Leadership and Management
• Collaborate with AS Functional Head and People Department to identify needs and participate in recruiting, hiring
• Lead and develop a cohesive, balanced, and high functioning team focused on producing high quality deliverables and outcomes
• Provide support to the team through excellent change management skills
• Optimize the organizational design and allocation of team resources across the Technical Lab Operations to meet the needs of a growing pipeline of products as well as critical non-program strategies and initiatives
• Mentor, coach and inspire Analytical Services team on BioMarin skill and career development
• Ensure all individual training and guidelines are kept current.
• Set short- and long-term Analytical Services department goals oriented to a high performing Analytical Services function (e.g., Objectives and Key Results (OKRs))
• Manage annual budget, operational expenditures, and forecasting activities
• Delegate responsibilities of laboratory equipment qualification and maintenance, where applicable
• Review protocols, experimental designs to support clear instructions for implementation and execution of experiments
• Support analytical design of special studies for product development activities
• Provide technical expertise for analytical methods and analysis of trends for data
• Review and approve documents such as, but not limited to, standard operating procedures, protocols, reports and QMS records
• Collaboratively lead the strategic expansion of laboratory capabilities including drug product forensics capabilities.
• Provide technical support to Manufacturing, Quality and QC during manufacturing and/or investigations, when required

Regulatory and Compliance:

• Ensure the laboratory in an inspection-ready state and that all Analytical Services staff take part in maintaining the lab in an inspection ready state
• Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives when needed
• Ensure the team is compliant to safety and environmental standards

Process Improvement & Training:

• Support the implementation and management of GxP, Non-GxP, & Method and phase-appropriate testing within Analytical Services
• Support improvement activities to ensure delivery of scientifically sound and analytical methods
• Support or lead continuous improvement in procedures and systems to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH)

Skills & Experience:

• Process Development and/or Manufacturing science experience preferred
• Experience in process analytics as part of process development work
• Experience leading teams through organizational change
• Expertise in biochemical techniques such as enzymatic activity, enzyme kinetics, and cell-based method.
• Expertise in separations methods
• Excellent people development skills and team leadership
• Excellent communication and stakeholder management skills
• Organizational skills and aptitude for developing robust processes to improve efficiency in the labs
• Experience supporting CMC teams preferred

Education:

• B.S +10 years experience, MSc + 8 years experience, or PhD + 3-5 years experience

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.