Location: Harmans,MD, USA
The Supervisor, QC is responsible for leading analytical testing, investigations, and key deliverables for the Quality Control (QC) group. The Supervisor, QC must demonstrate expert technical knowledge, mentors direct reports on basic scientific/regulatory principles, possess initiative, and maintains a strong commitment to scientific excellence as well as a strong cGMP understanding and mindset to help drive compliance within the department.
Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
Shift: Monday-Friday 8am-5pm
The role:
* Supervise the day to day operations in assigned area of the QC department.
* Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines
* Drive department process improvements which will increase efficiency and compliance
* Ensure department adherence to batch record, stability protocol timelines and deliverable dates
* Ensure department adherence to target deadlines for deviations, laboratory investigations, and trackwise actions
* Responsible for document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending
* Build effective teams that apply their diverse skills and perspectives to achieve common goals.
* Drive engagement and create a culture where employees are motivated to do their best.
* Oversee daily activity for the group to ensure quality results Performance management for direct reports.
* Understands company/department goals and practices and apply them when resolving a variety of problems.
* Oversee assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC and Capillary Electrophoresis
* Generate internal and external documents such as assay protocols, summary reports, and SOPs
* Work with clients to support resolution of concerns/hurdles seen during GMP manufacturing campaigns, on going stability studies, and method verifications.
The candidate:
* Bachelor in a Life Sciences discipline with 6 - 8 years of experience working in a cGMP QC laboratory.
* Masters' in a Life Sciences discipline with 4 - 6 years of experience working in a cGMP QC laboratory.
* Experience with ELISA, ddPCR, qPCR, Empower 3 preferred but not required.
* Expert relevant to QC analytical methods used for protein chemistry and molecular biology
* Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in QC function with a strong familiarity of general GMP practices
* Experience in writing SOPs
* Expert experience with biochemistry, as well as generating/reviewing the documentation that supports such work
* Expert knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks
The anticipated salary range for this position in Maryland is $93,280-$128,260 plus an annual bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
Why you should join Catalent:
* Competitive medical benefits and 401K
* 152 hours PTO + 8 Paid Holidays
* Dynamic, fast-paced work environment
* Opportunity to work on Continuous Improvement Processes
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
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Catalent is an Equal Opportunity Employer, including disability and veterans.
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