Senior Manager, QC Analytical Development

· BS/BA in Chemistry or related scientific field required. Equivalent combinations of education, training, and relevant work experience may be considered.

· 10+ years of cGMP experience in the pharmaceutical industry, Steriles manufacturing experience required.

· 7+ years in a leadership role, committed to employee engagement and development required.

· Outstanding attention to detail and organizational skills.

· Capable of excelling in a fast-paced environment, adept at multitasking. Demonstrates ability to maintain a high degree of confidentiality. Effective time management and prioritization skills.

· Requires discretion and independent judgment.

· Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters.

· Highly effective verbal and written communication skills. Proficiency in Microsoft Suite (Word, Excel, PowerPoint).

· Superior cGMP experience and leadership required.

· Knowledge of quality control statistics, documentation and adherence to SOP’s.

· Upholds Data Integrity and cGMP standards. High attention to detail.

· Makes safety a priority

· Adaptable to changing product release priorities, flexible and structured communication skills. Ability to delegate.

· Knowledge of Microbial test methods including Bacterial Endotoxin and Sterility testing. Particulate Matter testing a plus.

· Ability to write quality technical reports and give effective oral presentations.

· Ability to effectively collaborate with others to achieve team goals and expectations.

· A genuine interest in researching and implementation of new approaches to analysis.

· Provide leadership by driving organizational change, empowering staff, cultivating relationships, building effective teams, fostering engagement, and supporting staff in achieving both personal career goals and organizational objectives.

· Lead chemical Analytical Developmental and method transfer activities for New Business Development projects, and enhance analytical methods as required.

· Assess technical responses to regulatory agencies (e.g., FDA and USP), advise Manufacturing/Quality Operations Division and VP of Operations on analytical chemistry, review regulatory submissions while negotiating analytical support for product revisions and new product introductions.

· Develop and monitor capital equipment and operating budgets, and engage in both short-term and long-range planning for the Lab Services Department.

· Maintain an injury-free and incident-free workspace while aligning with all job-related safety and training requirements.