This position requires a variety of skills necessary for biotech company operations. The position is expected to possess a thorough understanding of cell culture and pilot scale bioreactor procedures and can reliably conduct cell culture process development with independence. The Upstream Process Development group is responsible for robust and optimized cell culture manufacturing processes that are developed for every mammalian cell line that has the potential to go into cGMP Manufacturing. In addition, this group is responsible for fulfilling small scale (shake flask through 250L) protein production.
Specific Duties, Activities, and Responsibilities:
This position will perform a variety of laboratory procedures in Upstream Process Development. The position will perform daily work assignments accurately and in a timely and safe manner and assist in the daily supervision of technical staff.
Advanced Delivery Technologies (ADT)
Education and Experience:
Ph.D. in Biotechnology, or related field with a minimum of 0-2 years of industry laboratory
MS in Biotechnology, or related field with a minimum of 2-4 years of industry laboratory experience
B.S/B.A. in Biotechnology, or related field with a minimum of 4-6 years experience of industry laboratory experience
Associates Degree/Certificate/Diploma in laboratory science with minimum of 6-8 years of industry laboratory experience
4+ years bioreactor experience in a process development environment
Exposure to a manufacturing setting for cGMP manufacturing
Experience operating, maintaining, and troubleshooting stirred vessel bioreactors
Experience in the design, execution and reporting of development projects aimed at maximizing cell culture performance
Aseptic technique experience
Mammalian cell culture experience is required
cGMP documentation and experience
Experience writing standard operating procedures, batch production records and internal and external reports
Ability to operate bioreactors, cell culture, and related equipment
Ability to use engineering and biological expertise to collaboratively design, develop and implement upstream processing methodologies suitable for transfer to the Manufacturing department
Ability to serve as a mentor to the technical staff
Ability to serve as a technical expert in cell culture process development on small and large scale bioreactor operations within the Department
Ability to provide technical support/service for the routine analysis of samples from Process Development using BioHT, blood-gas analyzers, Cedex and HPLC
Ability to research, thoroughly test and implement new equipment and procedures.
Communicate effectively and follow detailed written and verbal instruction; ability to clearly communicate with others groups and clients as necessary
Ability to review data to ensure data is well organized with complete documentation
Ability to plan, schedule, delegate, and carry out work for successful project completion
Proficient in the operations of a computer with MS-Excel, MS-Word as well as programs for multiple pieces of laboratory or manufacturing equipment
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in Fiscal 2013 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.?
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
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 along with the job number and title to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.