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Actalent Senior Director/director Quality Control- Analytical in Hopkinton, Massachusetts

If interested, please send your resume to marcmill@actalentservices.com

Two openings right now:

Sr Director Salary: 180k-200k

Director Salary: 160k-180k

Top Skills Details:

1.Biologics experience

2.Analytical Development

3.HPLC/Molecular assay (Gels, SDS page, ELISA,)

4.People Management

Description:

The Sr Director/Director if Quality Control-Analytical will manage and oversee Quality Control; within QC this will be from Clinical Development to Clinical Supply production, within a Commercial manufacture at a Contract Development & Manufacturing Organization (CDMO). The candidate will work in close collaboration with Manufacturing, Supply Operations, Process Sciences and Quality Assurance to support continual improvement and cGMP compliance. The Sr Director will work functionally as well as part of a multi-disciplinary team to support the development and approval of our clinical development programs, commercial operations, and implement strategic imperatives within a face paced environment.

Duties and Responsibilities

Will manage teams of Directors/Sr. Managers and professionals within Quality Control

Hire and develop employees within the department, while setting clear expectations for success

Provides active feedback, coaching and employee development

Establish and maintain the Quality Control operations at Milford, MA site

Manage analytical method transfer and method validation activities; An in depth understanding of protein chemistry and analytical chemistry methodologies

Includes, testing such as peptide mapping, glycan analysis, SEC-HPLC, IEX-HPLC, potency analysis by chromogenic assay

Create, organize and maintain a stability program for all client products

Ensure timely execution of client projects and clear communications to Clients

Execute timely testing of drug substance and drug product to cGMP

Identify and initiate improvements to Quality Control Systems, ensuring compliance to all relevant quality standards and regulatory requirements

Verify & establish department readiness for audits by both internal and external authorities, serve as primary Quality Control contact for regulatory inspections and client audits

Provide direct hands-on technical leadership of method qualification and validation

Institute and sustain a robust, timely stability program for clients

Support establishment and/or enhancement of Quality Control and operational metrics

Analyze regulatory authorities’ programs, guidance documents and activities in areas relevant to testing of biological products.

Consistently advise site and Quality management of potential and actual actions that could adversely affect the business; represent quality exposures or represent opportunities to be pursued.

Evaluate the functional strengths and developmental areas in the Quality Control organization and focus on continuous improvement

Coordinate and support the creation of and revisions to Standard Operating Procedures (SOPs) within Quality Control

Collect and report of quality control metrics via Quality Management Reviews and the Quality Council

Promotes a strong Quality Culture based on the core values

ERIC: Ethical, Respect, integrity & Collaborative

Additional Skills & Qualifications:

BS required, MS preferred in a scientific/technical discipline with 15+ years of experience in a QC position within the biological and/or CDMO industry.

10+ years in a management/leadership role(s)

PhD in a scientific/technical discipline a plus.

Experience in microbiological methods and contamination control

Subject matter experiment in method qualification and validation

Ability to apply GMP regulations and international guidelines to all aspects of the position •

Experience with regulatory inspections and client audits specifically within a startup/early phase and commercial QC laboratories

Extensive experience with writing and managing investigations and risk assessments

Proficient in MS Office application suite as well GMP electronic applications such as LIMS

Outstanding leadership abilities with demonstrated analytical and critical thinking skills while managing high performing teams

Proven leader, delegator, and decision maker with the ability to interact with all levels

Executive presence with strong interpersonal and communication skills, verbal and written

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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