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.
This role is a fulltime position working days; Monday - Friday
As a Senior Scientist – Separations in Catalent’s Biologics II team, your work will make a difference. You will support the development novel biotherapeutics. These treatments help make a difference in the lives of patients who have cancer, diabetes, and rare diseases. The Senior Scientist – Separations will develop and qualify/validate novel assays for these therapies. The main activities for the Senior Scientist, Separations include providing and reporting data, as required by project contracts within the Biologics Department. The data may be used for submission in Regulatory packages, release and stability testing of clinical and animal trial dose forms and in support of development projects.
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.
The Role:
In support of large molecule therapeutics, develop and execute laboratory work plans/schedules for self and junior members of team, using customer milestones and Division/Site performance standards and metrics. Sample types include in-process, release or stability. Techniques may include any or all of the following:
HPLC/UPLC techniques/methods (e.g. SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis, etc.)
Karl Fischer,
Compendia assays, (i.e. appearance. pH, etc.)
UV-Vis, Solo-VPE, Nano-Drop
Aggregation techniques such as MFI, AUC, SEC-MALS
Other technologies/methodologies as required by management
In support of large molecule therapeutics, perform and/or guide method validation or transfer activities. Perform method development activities.
Perform activities under cGMP as appropriate.
Authors and may approve technical documents, such as protocols, test methods, text reports, certificates of analysis, and operating procedures
Review technical documents for accuracy, thoroughness and regulatory compliance
Trains, coaches or mentors others on technical, personal development or business issues
Supervises technical staff, including work assignments and performance management
Responsible as Project Technical Lead with responsibility for project outcome and customer interaction
The Candidate
Education:
Degree in life sciences such as chemistry, biochemistry, biology or closely related physical science.
Experience:
Bachelors Degree: >10 years of relevant experience preferred or based on performance at Catalent.
Masters Degree: >8 years of relevant experience preferred or based on performance at Catalent.
Doctorate Degree: >4 years of relevant experience preferred or based on performance at Catalent.
Knowledge/Skills Requirements:
Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
Internal expert on data interpretation, applications, instrumentation and theory in at least one area of expertise. Consistently provides accurate data within the framework of regulatory guidance.
Evaluate and assess impact of proposed changes to controlled documents and/or project scope
Able to combine and interpret data from multiple disciplines for a project
Able to prioritize and suggest alternatives or contingencies to achieve the correct technical solutions with most efficient resource utilization
Can assess new technologies and their impact on Catalent offerings
Based on broad technical skills and drug development experience, anticipates and identifies unmet customer needs.
Understands the elements of a regulatory CMC filing package and the analytical documentation required therein.
Why you should join Catalent:
Medical, Dental, Vision and 401(k) are all offered from day one of employment
19 days of paid time off annually
Potential for career growth within an expanding team
Defined career path and annual performance review and feedback process
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.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
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 [email protected]. 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 [email protected] for us to investigate with local authorities.