Senior Scientist QC Analytical
Senior Scientist QC Analytical
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Job Description
The Senior Scientist QC Analytical is responsible for supporting analytical testing in order to support GMP manufacturing for both clinical and commercial clients. The Senior Scientist QC must demonstrate technical knowledgebe familiar with basic scientific/regulatory principles possess initiative and maintain a strong commitment to scientific excellence.
Catalent Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop manufacture and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma biotech and consumer health customers supporting product development launch and full lifecycle supply. With timetested experience in development sciences delivery technologies and multimodality manufacturing Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites Catalent supplies billions of doses of lifeenhancing and lifesaving treatments for patients annually.
Shift: Monday Friday 210:30pm
The role:
- Perform assays such as ELISA DNA/RNA extraction and gel electrophoresis qPCR ddPCR HPLC Capillary Electrophoresis Appearance Osmo and pH
- Troubleshoot testing issues escalate all needs and provide potential resolutions to maintain successful deliverables to support batch release stability testing and ad hoc testing.
- Mentor and develop other operational staff
- Act as a subject matter expert for at least two techniques. Understanding of the scientific nature current industry norms and functional working of testing in order to support discussion with auditors vendors instrumentation method services and other cross functional teams
- Drive cross functional teams in order to drive continuous improvement projects within the department
- Reports errors deficiencies discrepancies and observations to management that could impact product Quality on release.
- Create lead and manage change requests (CR) and corrective and preventive actions (CAPA) needed to ensure production changes and improvements are implemented in a timely manner.
The candidate:
- Bachelor in a Life Sciences discipline with 4 6 years of experience working in a cGMP QC laboratory.
- Masters in a Life Sciences discipline with at least 2 years of experience working in a cGMP QC laboratory.
- Experience with any of the following techniques is preferred ELISA qPCR ddCPR HPLCCE
- Knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology
- Experience within the biologic pharmaceutical or medical device industry performing direct handson work in QC function with a strong familiarity of general GMP practices
- Experience in writing SOPs
- Broad experience with biochemistry as well as generating/reviewing the documentation that supports such work
The anticipated salary range for this position in Maryland is $93280 $128260 plus an annual bonus target. 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 multistate 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 fastpaced 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 7000 lifesaving and lifeenhancing 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.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability you may submit your request by sending an email and confirming your request for an accommodation and include the job number title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment bank details photocopies of identification social security number or other highly sensitive personal information during the offer process and we NEVER do so via email or social media. If you receive any such request DO NOT respond it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Required Experience:
Senior IC
Employment Type
Full-Time
