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The Senior Manager, Analytical Development reports to the Senior Director of QA\QC. The position requires leading the analytical chemistry laboratory through all phases of product development. The position is responsible for managing the analytical evaluation of drug substances, excipients, drug product intermediate, finished drug product, cleaning assay development and stability samples. The Senior Manager will be required to work in development and regulated environments, including adherence to cGMPs, regional and country specific regulations, as well as internal SOPs. The person is a subject matter expert in assay validation according to pertinent regulatory guidelines. The person leads a dynamic team of advanced degree professionals. The person is responsible for managing a group that supports the regulatory requirements for all assays that are required for drug approval (e.g., extractable and leachable studies, assay\impurities, nitrosamine and trace metal assessments, etc).
ESSENTIAL DUTIES & RESPONSIBILITIES
- Oversee testing activities in several of the following functions but not limited to raw material, component, drug product, stability, validation, investigational, in-process testing, etc.
- Serve as a subject matter expert for analytical testing.
- Lead, guide, and mentor analysts both in analytical development and quality control
- Foster a culture of continuous improvement and collaboration
- Expert in chromatographic methods and a wide variety of detection techniques (e.g., MS, MS\MS, UV\Vis, ELSD, CAD, etc.).
- Build an analytical development staff that compliments each other in skill sets.
- Support formulation, process development, and scale-up activities
- Review and approve analytical data for accuracy and completeness.
- Lead and serve on cross-functional project teams.
- Prepare protocols, technical reports, and other documentation for CMC related activities according to regulatory requirements.
- Identify and resolve project-related issues that have the potential to impact project deliverables.
- Ensure compliance of laboratory personnel and equipment
- Prepare annual laboratory budgeting and manage accordingly.
- Perform annual performance assessments of direct reports.
QUALIFICATIONS
- PhD Degree in chemistry, biology, or related science and 8-10 years of experience in pharmaceutical laboratory management with an emphasis on analytical instrumentation required for pharmaceutical development (e.g, UPLC\HPLC, MS. MS/MS.
- Must possess strong knowledge of SOPs, laboratory procedures, FDA, and ICH guidance, USP regulations, analytical testing techniques, and cGMP.
KNOWLEDGE, SKILLS, & ABILITIES
- Strong track record of leadership skills and influence
- Strong interpersonal skills. Ability to build effective and constructive relationships.
- Ability to work cross-functionally both internally and externally.
- Must be a leader, mentor, and self-motivated to develop a high performing team.
- Must possess excellent written and verbal communication skills, interpersonal skills, management skills, strong work ethic, and organizational skills.
- Demonstrated analytical and problem-solving skills.
- Ability to work with minimal supervision.
- Able to lead complex analytical challenges and communicate to senior leadership and clients
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· Prolonged periods sitting at a desk and working on a computer.
· Must be able to lift up to 15 pounds at times.
August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.
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