Responsibilities:

The Contract Manager / Senior Manager - CMC QC will:

• Support the external contract organization activities to fulfill the GMP QC testing needs

• Provide internal support to CMC Operations to support the development, manufacture, and material release, including method transfer/qualification/validation and product shelf life. 

• Collaborate with PDAS, Manufacturing, CROs in performing seamless technical transfer of testing methods and assays, troubleshooting.

• Ensure that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies

• Support the development and validation of analytical methods used for QC testing 

• Implement and maintain quality systems to ensure the integrity and reliability of QC data

• Manage, review, and organize release/stability data from active stability programs and generate interim stability trending assessments and reports

• Work within CMC Ops, QA and other departments to address review comments on QC/analytical documents

• Manage/assist the document creation and review via the eQMS (e.g. ZenQMS)

• Create and update batch analysis tables for stability data

• Keep track of contract lab stability time point pulls for different programs

• Create Excel/JMP tables and graphs for stability data trending

• Initiate and manage change controls, deviations and CAPA in the eQMS

• Perform other duties, as needed

Qualifications:

• Bachelor's Degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related Life Science field with 5-8 yrs experience within the biotech/pharma industries

• 3 years of Analytical / Quality Control experience in a GMP environment

• Good understanding of cGMPs, ICH stability, and Regulatory Drug requirements

• Microsoft Office proficient (Excel, Word, etc.)

• Great interpersonal skills

• Excellent communication skills (written and verbal)

• Strong attention to detail

• Highly organized

Desired Skills:

• Working experience and knowledge in a wide variety of Quality Control Stability methodologies

• Experience in conducting Stability Studies per ICH Guidelines

• Proficient in Statistical Analysis software (e.g. JMP)

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.